脊髓损伤康复的临床研究
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摘要
目的
本研究对脊髓损伤的康复进行临床研究，主要探讨以下几个方面的问题：①制定一个适合国人文化背景和实际的日常生活活动能力评定量表(AMS)，并对其信度和效度进行分析，以便能够在临床上广泛地应用；②对康复介入的时机进行对照研究，进一步明确早期康复介入的时机以及早期康复对脊髓损伤功能的影响；③通过临床对照研究，证明康复治疗对脊髓损伤功能恢复的重要作用；④合理情绪疗法对脊髓损伤患者心理状态和功能状态的影响。
对象和方法
2004年09月～2006年09月在我院骨科或康复科住院的脊髓损伤患者180例，部分患者出院后仍坚持按原方案继续门诊治疗，直至本研究结束。本研究周期为3个月。
研究设计：双盲法，随机分组对照临床研究。
评定内容：患者的一般状况、损伤平面、ASIA分级、日常生活活动能力评定量表(Activities of daily living Measure Scale，AMS)、Barthel指数(Barthel Index，BI)、功能独立性评定(Functional Independence Measure，FIM)、汉密顿抑郁量表(Hamilton depression rating scale，HAMD)、汉密顿焦虑量表(Hamilton anxietyrating scale，HAMA)、Beck抑郁问卷(Beck depression inventory，BDI)。
评定方法：所有纳入本研究的SCI患者，治疗前、治疗后各进行一次康复评定。评定人员由固定康复科医师、物理治疗师(PT)、心理治疗师(ST)进行，以上评定人员均先进行评估方法及注意事项的培训，以保证评估标准的一致性和数据的可靠性。
康复治疗：康复治疗根据患者的临床不同阶段采用不同的训练方法；心理治疗采用合理情绪疗法(Rational-Emotive Therapy，RET)。
结果
1、AMS的信度和效度分析：本研究选择30例SCI患者进行AMS的信度和效度分析，我们把AMS得分根据量表的结果分别计算其运动得分(AM)、认知得分(AC)、总分(AT)，采用SPSS12.0统计学软件，Pearson相关分析法。
(1)组内信度：同一测试者相隔一周的两次测量的结果比较分析：AM1与AM2、AM1与AT2、AC1与AC2、AT1与AM2的Pearson相关系数分别为0.999、0.983、0.982、0.992、0.992，显示同一评定人两次评定的结果高度相关，说明AMS有较好的组内信度。
(2)组间信度：不同测试者(甲、乙)测量的AMS得分之间进行相关性分析，甲AM与乙AM、甲AM与乙AT、甲AC与乙AC、甲AT与乙AM、甲AT与乙AT之间的Pearson相关系数分别为0.999、0.991、0.964、0.992、0.999，显示不同测试者(甲、乙)评定的结果之间高度相关，说明AMS有较好的组间信度。
(3)表面效度：专家的评价认为，该量表内容和结构较为合理，表中所检测的条目能够反映SCI患者功能状况的基本特征，具有较好的表面效度，能够达到研究的预期目标。
(4)标准效度：将AMS与FIM和BI进行相关性分析，治疗前测试结果显示：AMl与FMl、AMl与FTl、AMl与BIl、ATl与FMl、ATl与FTl、ATl与BIl的Pearson相关系数分别为0.900、0.880、0.924、0.880、0.854、0.903；治疗后测试结果显示：AM2与FM2、AM2与FT2、AM2与B12、AT2与FM2、AT2与FT2、AT2与BI2的Pearson相关系数分别为0.825、0.840、0.788、0.828、0.846、0.790，显示AMS与FIM和BI量表的评分相关，说明AMS具有较好的标准效度。
(5)敏感度：30例SCI患者治疗前AMS得分为33±16.02，治疗后得分为67.57±14.38，前后比较t值12.36，P=0.000，具有统计学意义，说明该量表的敏感性较好。另外又使用效应尺度统计量来评价该量表的敏感度，计算出该效应尺度为2.16，表明该量表具有较大效应，因而敏感性较好。
2、康复治疗介入时机的结果：
选取SCI患者80例，把伤后＜1个月内康复介入和＞1个月康复介入的分为治疗组和对照组各40例，治疗前后分别评定患者的AMS、BI、FIM。结果，治疗前、治疗后、前后差值分别为：AMS得分治疗组38.23±17.88、73.68±27.38、35.45±18.13，对照组42.93±18.75、63.45±19.41、20.53±12.56；BI得分治疗组23.38±15.50、53.13±28.46、29.75±16.01，对照组25.50±17.28、43.63±20.25、18.13±11.80；FIM得分治疗组55.98±16.76、92.78±24.72、36.80±14.97，对照组62.75±14.44、84.50±17.85、21.75±11.62。
统计学分析：各组治疗前后比较，P均为0.000，有统计学意义。治疗前、后两组间的AMS、BI、FIM比较，P＞0.05，无统计学意义；两组间AMS、BI、FIM的差值比较，P均为0.000，有统计学意义。结果说明早期康复介入更有利于SCI患者功能的恢复。
3、康复治疗的研究结果：
本研究对100例患者进行临床对照研究，把因各种原因未能进行康复治疗的50例患者与在临床治疗的同时进行系统康复的50例患者分为对照组和治疗组，治疗前后分别评定患者的AMS、BI、FIM。结果，治疗前、治疗后、前后差值分别为：AMS得分治疗组35.14±16.77、72.64±23.44、37.50±20.81，对照组37.87±19.01、44.92±20.36、7.05±3.95；BI得分治疗组18.50±14.22、56.80±26.45、38.30±18.34，对照组22.40±15.79、29.60±18.95、7.20±4.54：FIM得分治疗组55.88±7.79、94.50±19.75、38.62±18.09，对照组58.24±9.83、67.60±11.18、9.36±3.70。
统计学分析：比较两组间的AMS、BI、FIM得分情况，采用独立样本t检验。结果，治疗前治疗组和对照组的AMS、BI、FIM的t值分别为-0.762、-1.298、-1.330，P值分别为0.448、0.197、0.187，无统计学意义。治疗后两组AMS、BI、FIM得分以及AMS前后差值、BI前后差值、FIM前后差值的t值分别为5.911～11.640，P值为0.000，均有统计学意义。说明康复治疗能明显改善SCI患者运动功能和日常生活活动能力(ADL)。
4、心理治疗的结果：
(1) SCI患者心理状态及相关因素分析：
选取120例SCI患者，进行心理状况的评定，以HAMD、BDI评定患者的抑郁状态，HAMD评定患者的焦虑状态，AMS、BI、FIM评定患者的功能状态。
结果：有抑郁者112例，占93.33％；有明显焦虑(＞21分)和严重焦虑(＞29分)者115例，占95.83％。说明SCI患者普遍存在抑郁和焦虑情绪。
抑郁状态的相关因素：HAMD评分与年龄、性别、损伤平面的Pearson相关系数分别为-0.003、0.008、-0.046，无统计学意义，与ASIA、AMS、BI、FIM的相关系数分别为-0.780、-0.308、-0.540、-0.407，有统计学意义；BDI评分与年龄、性别、损伤平面的Pearson相关系数分别为0.014、-0.034、-0.122，无统计学意义，与ASIA、AMS、BI、FIM的Pearson相关系数-0.673、-0.433、-0.548、-0.429，有统计学意义。说明抑郁状态评分与年龄、性别、损伤平面无关，与ASIA分级和患者的功能状态(AMS、BI、FIM)相关。
焦虑状态的相关因素：HAMA评分与年龄、性别的Pearson相关系数分别为0.010、-0.049，无统计学意义，与损伤平面、ASIA、AMS、BI、FIM的Pearson相关系数-0.887、-0.281、-0.524、-0.639、0.559，有统计学意义。说明焦虑状态评分与年龄、性别无关，与损伤平面、ASIA分级和患者的功能状态(AMS、BI、FIM)相关。
(2)心理治疗对心理状态影响的结果：
对120例SCI患者，根据分组原则和程序分为对照组和治疗组各60例，治疗组增加心理治疗(合理情绪疗法)，应用HAMD、BDI、HAMA评估患者的心理状态。治疗前后结果：HAMD治疗组35.53±8.83、18.43±4.85，对照组36.43±8.90、32.17±9.28；BDI治疗组21.77±5.35、10.65±4.02，对照组23.63±4.97、18.95±5.41；HAMA治疗组39.17±8.57、20.90±6.35，对照组38.53±8.87、34.17±9.04。
统计学分析：采用独立样本t检验，比较分析两组间的HAMD、BDI、HAMA得分情况：治疗前HAMD、BDI、HAMA的t值分别为-0.556、-1.979、0.398，P值分别为0.579、0.055、0.691，无统计学意义；治疗后HAMD、BDI、HAMA的t值分别为-10.179、-9.542、-9.300，P值均为0.000，有统计学意义；两组HAMD、BDI、HAMA治疗前后差值比较，t值分别为-16．289、-8.439、-14.639，P值均为0.000，有统计学意义。说明合理情绪疗法可明显改善脊髓损伤患者的心理状态。
(3)心理治疗对运动功能的结果：
采用AMS、BI、FIM对两组病人治疗前后的运动功能进行评定，以研究心理治疗在改善SCI患者心理状态的同时，对其运动功能的影响。结果：①治疗前后治疗组的AMS分别为34.58±16.47，72.65±23.52，对照组分别为40.51±18.25，56.13±22.40；②治疗前后治疗组的BI分别为18.00±13.78，58.50±26.99，对照组分别为23.92±17.90，42.08±22.20；③治疗前后治疗组的FIM分别为55.38±8.02，95.23±20.04，对照组分别为59.77±13.87，78.73±15.65。
统计学分析：采用独立样本t检验，比较分析两组间的AMS、BI、FIM得分情况：治疗前AMS、BI、FIM比较的t值分别为-1.867、-2.029、-2.119，P值分别为0.064、0.072、0.076，无统计学意义；治疗后AMS、BI、FIM比较的t值分别为3.941、3.639、5.027，P值均为0.000，有统计学意义；③两组AMS、BI、FIM治疗前后差值比较，t值分别为7.514、7.300、7.566，P值均为0.000，有统计学意义。说明合理情绪疗法可明显改善脊髓损伤患者的功能状态，提高他们的ADL能力。
结论
1、日常生活活动能力评定量表(AMS)具有良好的信度和效度，在临床上能够广泛应用于脊髓损伤患者ADL的评定；
2、早期康复介入能明显促进脊髓损伤功能的恢复，康复应尽量在伤后1个月之内介入；
3、康复治疗对脊髓损伤的功能恢复具有重要作用；
4、脊髓损伤患者普遍存在抑郁和焦虑情绪，合理情绪疗法能明显改善脊髓损伤患者心理状态，从而促进患者功能状态的恢复。
本研究创新之处：
1、在国内外率先把合理情绪疗法应用于脊髓损伤的心理治疗。RET是心理治疗的一个重要的治疗方法，根据RET的心理学原理和治疗理念，分析SCI后患者的心理特征，RET作为心理治疗方法对SCI患者的心理障碍确实具有针对性。目前，虽然国内外有不少关于RET的研究，但把RET方法应用于疾病的临床研究较少，特别是应用于SCI的心理治疗未见报道。
2、制定了日常生活活动能力评定量表(AMS)并证明了其具有较高的信度和效度，可以推广应用，能够广泛用于脊髓损伤患者ADL的评定。在康复评定的研究上，目前国内尚无统一的日常生活活动能力的评定量表，不便于多中心的合作研究以及学术交流，因此根据国际上通用的有关日常生活活动能力的评定量表，结合国内的实际及文化背景，制定国内统一的日常生活活动能力评定量表，具有重要的意义。
3、双盲、随机对照的研究方法是临床研究的权威研究设计，本研究在国内首次采用双盲、随机分组对照设计方案对脊髓损伤的康复开展临床研究。康复治疗对于SCI患者的功能恢复具有重要意义，但国内众多的有关SCI康复的研究报道，基本上都是自身前后对照，缺乏随机分组对照研究，更没有设盲；对于早期康复介入的时机，缺乏统一的标准，因此研究结果说服力不强。本研究在国内首次采用双盲、随机分组对照设计的临床研究，证明了康复治疗对SCI的功能恢复具有重要的影响，特别是早期康复，应该在1个月之内介入，对SCI患者的的功能结局更为有利。
Objective: There are several aspects of rehabilitation of spinal cord injury to discuss in this study:①Activity of daily living measure scale(AMS) was established to suit the people cultural context and actual of China. The reliability and validity of AMS was analysed, in order to prove that the AMS can apply on clinic widely;②The rehabilitation involvement opportunity was conducted with the groups comparison, in order to clear further about the opportunity of early rehabilitation involvement as well as the influence of early rehabilitation on the function of patients with SCI;③Through the clinical comparison research, the vital role of the rehabilitation treatment which restores to function of patients with SCI was proved;④The influence of Rational-Emotive Therapy(RET) on the psychologic and functional condition of the patients with SCI.
Object and method: 180 cases patients with spinal cord injury in orthopedics or rehabilitation department in hospital during September 2004 to September 2006 was involved in this study. The partial patients left the hospital still persist in the original rehabilitation program until this research is over. This research duration is 3 months.
Study design: Doulbe-blinded, two groups randomized controlled trial, with pretreatment and posttreatment measures.
Setting: Rehabilitation clinics.
Measure contents: The follow measurement were taken in this study: Patient's general condition, damage plane, ASIA grade, Activities of daily living Measure Scale (AMS), Barthel index (BI), Functional independence measure(FIM), Hamilton depression rating scale(HAMD), Hamilton anxiety rating scale(HAMA), Beck depression inventory (BDI).
Measure methods: All SCI patients integrated in this research were evaluated with above measures pre and post rehabilitation treatment. Rehabilitation assessmet were carried on by rehabilitation doctor, physical therapist (PT), psychological therapist (ST). The measure method and attention notes of rehabilitaion assessment was trained to guarantee the measure standard uniformity and the data reliability.
The rehabilitation treatment program was carried on according to different clinical stage of patient; Rational-Emotive Therapy (RET) was taken in psychotherapy to the patients with SCI.
Results:
1、Reliability and validity analysis of the AMS: The reliability and validity of AMS was analysised by Pearson related analytic method of SPSS12.0 statistics software in 30 cases patients with SCI. The AMS scores is consist of movement score (AM), cognition score (AC), total score (AT).
(1) Intergroup reliability: the AMS scores of two times measured by the identical observer within a week-long was analysis: The Pearson correlation coefficient between AM1 and AM2, AM1 and AT2, AC1 and AC2, AT1 and the AM2 is respective 0.999, 0.983, 0.982, 0.992, 0.992. It showed that the relation between the scores of two times measured by the identical observer is high. It demonstrated that AMS has good inter-group reliability.
(2) Between-groups reliability: The AM,AC,AT scores measued by a observer(A) was compared with another observer(B) by Pearson relation. The Pearson correlation coefficient between AM(A) and AM(B), AM(A) and AT(B), AC(A) and AC(B), AT(A) and AM(B), AT(A) and AT(B) is respective 0.999, 0.991, 0.964, 0.992, 0.999. The results showed highly relations of the scores between two observers. It demonstrated that the AMS has good between-groups reliability.
(3) Face validity: Expert's appraisal believed that the content and structure this measure scale are reasonable, the clause in the table can reflect the basic characteristic to SCI patient's functional condition. It shows that the AMS has the good face validity and the research of rehabilitation assessment on SCI measured by AMS can achieve the anticipated target.
(4) Criteria validity: The correlation analysis AMS and FIM and BI was carried on pre and post treatment by pearson relation. The Pearson correlation coefficient of AM1 and FM1, AM1 and FT1, AM1 and BI1, AT1 and FM1, AT1 and FT1, AT1 and BI1 is respective 0.900, 0.880, 0.924, 0.880, 0.854, 0.903 pre treatment; The Pearson correlation coefficient of AM2 and FM2, AM2 and FT2, AM2 and BI2, AT2 and FM2, AT2 and FT2, AT2 and the BI2 is respective 0.825, 0.840, 0.788, 0.828, 0.846, 0.790 post treatment. It is showed that AMS is relative highly with FIM and the BI and has good criteria validity.
(5) Sensitivity: The AMS scores(67.57±14.38) of post treatment is significant improved comparing with the scores(33±16.02) pre treatment (t=12.36, p=0.000). It shows that the sensitivity of AMS is good. Moreover the effect size statistics was used to evaluate the sensitivity of AMS. The effect size is 2.16 and shows that AMS has big effect. Thus the sensitivity of AMS is good.
2、The results of involvement opportunity of rehabilitation treatment on SCI:
According to the forecited grouping principle and the procedure, 80 cases patients with SCI were divided into two groups. 40 cases rehabilitation treatment involved within 1 month after the wound were divided into the treatmet group(TG). 40 cases rehabilitation treatment involved late to 1 month after the wound were devided into the control groupCG). AMS, BI, FIM were measured pre and post treatment. The AMS scorse pre treatment, post treatment, improved value is respective, TG38.23±17.88, 73.68±27.38, 35.45±18.13, CG42.93±18.75, 63.45±19.41, 20.53±12.56; BI scores is: TG 23.38±15.50, 53.13±28.46, 29.75±16.01, CG 25.50±17.28, 43.63±20.25, 18.13±11.80; FIM scores is: TG 55.98±16.76, 92.78±24.72, 36.80±14.97, CG 62.75±14.44, 84.50±17.85, 21.75±11.62.
Statistics analysis: The AMS,BI,FIM scores pre treatment of each group is significant difference compared with post treatment(statistics: P=0.000). The AMS, BI, FIM scores pre treatment is non-statistics significance compared between two groups (P＞0.05); AMS, BI, FIM scores post treatment as well as their improved value is statistics significance compared between two groups(P=0.000). The results explanation that earlier rehabilitation involvement is more advantageous to function restoration on the SCI patients.
3、rehabilitation treatment results:
100 patients with SC1 included in this study were divided into two groups. 50 cases who has not been able to treated with rehabilitation treatment because of each kind of reason were divided into control group(CG). 50 cases who were provided rehabilitation treatment were divided into treatment group(TG). AMS, BI, FIM were measured pre and post treatment. The AMS scorse pre treatment, post treatment, improved value is respective: TG 35.14±16.77, 72.64±23.44, 37.50±20.81, CG 37.87±19.01, 44.92±20.36, 7.05±3.95; The BI score: TG 18.50±14.22, 56.80±26.45, 38.30±18.34, CG 22.40±15.79, 29.60±18.95, 7.20±4.54; The FIM score: TG 55.88±7.79, 94.50±19.75, 38.62±18.09, CG 58.24±9.83, 67.60±11.18, 9.36±3.70.
Statistics analysis: AMS, BI, F1M score were compared between two groups by the independent sample t-test. The AMS, BI, FIM of pre treatment is non-statistics significance difference compared between TG and CG (t: -0.762, -1.298, -1.330; P 0.448, 0.197, 0.187). AMS, BI, FIM scores post treatment as well as their improved value is statistics significance difference compared between two groups(t=5.911～11.640; P=0.000). It explains rehabilitation treatment can improve the SCI patient movement function and ability of daily life (ADL) obviously.
4、psychology treatment results:
(1) SCI patient's psychology and correlation factors analysis:
120 SCI patients were involved in this study. Depression was evaluated by HAMD, BDI and anxious condition was evaluated by HAMA. AMS, BI, FIM were evaluated to functional condition of SCI patients. In 120 cases, 112(93.33%) patients suffered the depression and 115(95.83%) patients suffered obvious anxious (＞21) and serious anxious (＞29). It explains that there is generally depression and anxious in the SCI patients.
Correlation factors to depression: The Pearson correlation coefficient of HAMD score compared with the age, the sex, the course of illness, the damage section is respective -0.003, 0.008, 0.066, -0.046. HAMD score compared with ASIA, AMS, BI, FIM, The Pearson correlation coefficient is respective -0.780, -0.308, -0.540, -0.407. The Pearson correlation coefficient of BDI score compared with the age, the sex, the course of illness, the damage section is respective 0.014, -0.034, 0.160, -0.122. BDI score compared with ASIA, AMS, BI, FIM, the Pearson correlation coefficient is respective -0.673, -0.433, -0.548, -0.429. It explains that depression of SCI patients do not related with the age, the sex, the course of illness, the damage section and is closly relative with ASIA and patient's functional condition (AMS, BI, FIM).
Correlation factors to anxious: The Pearson correlation coefficient of HAMA compared with the age, the sex, the course of illness is respective 0.010, -0.049, 0.146, HAMA compared with the damage section, ASIA,AMS,BI,FIM, the Pearson correlation coefficient is respective -0.887, -0.281, -0.524, -0.639, 0.559. It explains that the anxious of SCI patients do not related with the age, the sex, the course of illness and is relative with the damage section, ASIA and patient's functional condition(AMS, BI, FIM).
(2) Influence of Rational-Emotive Therapy on psychology condition of SCI patients:
120 SCI patients who were treated with rehabilitation program were divided into the control group(CG) 60 cases and treatment group(TG) 60 cases according to the grouping principle and procedure. The patients in treatment group was treated with RET while they were been suffering rehabilitation training. Psychology assessment was evaluated by HAMD, BDI, HAMA. The HAMD scores of pre and post treatment is: TG 35.53±8.83, 18.43±4.85, CG 36.43±8.90, 32.17±9.28; The BDI scores of pre and post treatment is: TG 21.77±5.35, 10.65±4.02, CG 23.63±4.97, 18.95±5.41; The HAMA scores of pre and post treatment is: TG 39.17±8.57, 20.90±6.35, CG 38.53±8.87, 34.17±9.04.
Statistics analysis: The HAMD, BDI, HAMA scores were compared between two groups by the independent sample t-test. The HAMD, BDI, HAMA scores of pre treatment is non-statistics significance difference compared between two groups(t=-0.556, -1.979, 0.398, P=0.579, 0.055, 0.691). The HAMD, BDI, HAMA scores of post treatment and their improved value is statistics significance difference compared between two groups(t=-16.289～-8.439, P=0.000). It explains that Influence of Rational-Emotive Therapy on psychology condition of SCI patients is remarkable.
(3) Influence of Rational-Emotive Therapy on movement function of SCI patients:
AMS, BI, FIM were evaluated in the assessment of movement function and ADL of SCI patients in order to explore the influence of RET on the movement functional condition while psychology condition were improved. Results: The AMS scores of pre and post treatment is respective: TG 34.58±16.47, 72.65±23.52, CG 40.51±18.25,56.13±22.40; The BI scores of pre and post treatment is respective: TG 18.00±13.78, 58.50±26.99, CG 23.92±17.90, 42.08±22.20; The FIM scores of pre and post treatment is respective: TG 55.38±8.02, 95.23+20.04, CG 59.77±13.87, 78.73±15.65.
Statistics analysis: AMS, BI, FIM scores of pre and post treatment were compared between two groups by the independent sample t-test. The AMS, BI, FIM scores of pre treatment is non-statistics significance difference compared between two groups(t=-1.867, -2.029,-0.119, P=0.064, 0.072, 0.076). The AMS, BI, FIM scores of post treatment is statistics significant difference compared between two groups(t=3.941, 3.639, 5.027, P=0.000). The improved value of AMS, BI, FIM is statistics significant difference compared between two groups(t=7.514, 7.300, 7.566, P=0.000). It is indicated that the RET can improve the movement function and ADL of SCI patients while psychology condition were improved.
Conclusions:
(1) There is the good validity and reliability in Activity of daily living measure scale(AMS). It can be widely applied in clinical to evaluate the movement function and ADL of patients with spinal cord injury.
(2) The early rehabilitation involvement can promote the spinal cord injury function restoration, the rehabilitation to be supposed obviously to involve as far as possible within 1 month after the wound.
(3) Rehabilitation treatment has the vital role to restore function of spinal cord injury.
(4) There are depression and anxious generally in patients with spinal cord injury. The Rational-Emotive Therapy can improve psychology condition of the patients with spinal cord injury obviously, thus promotes the patient's function condition restoration.
Innovation place of this study:
1、It takes the lead that the Rational-Emotive Therapy(RET) was applied to the psychotherapy of patients with spinal cord injury. RET is a important method of psychotherapy. According to the psychology principle and the treatment idea of RET and analysed the psychology characteristic of SCI patients, RET truly has pointed as the psychotherapy to the SCI patient's psychological barrier. At present, although there are many research about the RET in domestic and foreign, but applied the RET to the disease clinical research are less, specially applied to the SCI psychotherapy has not seen the report.
2、There is the good reliability and validity in Activity of daily living Measure Scale(AMS) and the widely appling in clinic to evaluate the movement function and ADL of patients with spinal cord injury. At present in domestic, there is not still a unification measure scale to evaluate ADL of SCI patients. It is very inconvenienced to the multi-central cooperation research as well as the academic exchange. Therefore, according to the international general measure scale related ADL, there is the vital significance to establish domestic unification scale of ADL for SCI patients linked to the domestic reality and the cultural context.
3、Doulbe-blinded, randomized controlled trial is the authority clinical study design. Doulbe-blinded, randomized grouping controlled trial was first designed in this study on rehabilitation of patients with SCI in domestic. Rehabilitation treatment is vital significance to improve the function of patients with SCI. But domestic multitudinous research reported of SCI is all basical own around comparing and lacks the grouping randomized controlled comparison, specially not supposed blindly; The opportunity of early rehabilitation involvement lacks the unification standard. Therefore the findings persuasive power is not strong. Doulbe-blinded, randomized grouping controlled trial was first designed in this study on rehabilitation of patients with SCI in domestic. The results show that the influence of rehabilitation treatment on the function of patients with SC1 is important, specially for the early rehabilitation involvement. The early rehabilitation should involving within 1 month and has more advantageous to functional outcome of patients with SC1.
本研究对脊髓损伤的康复进行临床研究，主要探讨以下几个方面的问题：①制定一个适合国人文化背景和实际的日常生活活动能力评定量表(AMS)，并对其信度和效度进行分析，以便能够在临床上广泛地应用；②对康复介入的时机进行对照研究，进一步明确早期康复介入的时机以及早期康复对脊髓损伤功能的影响；③通过临床对照研究，证明康复治疗对脊髓损伤功能恢复的重要作用；④合理情绪疗法对脊髓损伤患者心理状态和功能状态的影响。
对象和方法
2004年09月～2006年09月在我院骨科或康复科住院的脊髓损伤患者180例，部分患者出院后仍坚持按原方案继续门诊治疗，直至本研究结束。本研究周期为3个月。
研究设计：双盲法，随机分组对照临床研究。
评定内容：患者的一般状况、损伤平面、ASIA分级、日常生活活动能力评定量表(Activities of daily living Measure Scale，AMS)、Barthel指数(Barthel Index，BI)、功能独立性评定(Functional Independence Measure，FIM)、汉密顿抑郁量表(Hamilton depression rating scale，HAMD)、汉密顿焦虑量表(Hamilton anxietyrating scale，HAMA)、Beck抑郁问卷(Beck depression inventory，BDI)。
评定方法：所有纳入本研究的SCI患者，治疗前、治疗后各进行一次康复评定。评定人员由固定康复科医师、物理治疗师(PT)、心理治疗师(ST)进行，以上评定人员均先进行评估方法及注意事项的培训，以保证评估标准的一致性和数据的可靠性。
康复治疗：康复治疗根据患者的临床不同阶段采用不同的训练方法；心理治疗采用合理情绪疗法(Rational-Emotive Therapy，RET)。
结果
1、AMS的信度和效度分析：本研究选择30例SCI患者进行AMS的信度和效度分析，我们把AMS得分根据量表的结果分别计算其运动得分(AM)、认知得分(AC)、总分(AT)，采用SPSS12.0统计学软件，Pearson相关分析法。
(1)组内信度：同一测试者相隔一周的两次测量的结果比较分析：AM1与AM2、AM1与AT2、AC1与AC2、AT1与AM2的Pearson相关系数分别为0.999、0.983、0.982、0.992、0.992，显示同一评定人两次评定的结果高度相关，说明AMS有较好的组内信度。
(2)组间信度：不同测试者(甲、乙)测量的AMS得分之间进行相关性分析，甲AM与乙AM、甲AM与乙AT、甲AC与乙AC、甲AT与乙AM、甲AT与乙AT之间的Pearson相关系数分别为0.999、0.991、0.964、0.992、0.999，显示不同测试者(甲、乙)评定的结果之间高度相关，说明AMS有较好的组间信度。
(3)表面效度：专家的评价认为，该量表内容和结构较为合理，表中所检测的条目能够反映SCI患者功能状况的基本特征，具有较好的表面效度，能够达到研究的预期目标。
(4)标准效度：将AMS与FIM和BI进行相关性分析，治疗前测试结果显示：AMl与FMl、AMl与FTl、AMl与BIl、ATl与FMl、ATl与FTl、ATl与BIl的Pearson相关系数分别为0.900、0.880、0.924、0.880、0.854、0.903；治疗后测试结果显示：AM2与FM2、AM2与FT2、AM2与B12、AT2与FM2、AT2与FT2、AT2与BI2的Pearson相关系数分别为0.825、0.840、0.788、0.828、0.846、0.790，显示AMS与FIM和BI量表的评分相关，说明AMS具有较好的标准效度。
(5)敏感度：30例SCI患者治疗前AMS得分为33±16.02，治疗后得分为67.57±14.38，前后比较t值12.36，P=0.000，具有统计学意义，说明该量表的敏感性较好。另外又使用效应尺度统计量来评价该量表的敏感度，计算出该效应尺度为2.16，表明该量表具有较大效应，因而敏感性较好。
2、康复治疗介入时机的结果：
选取SCI患者80例，把伤后＜1个月内康复介入和＞1个月康复介入的分为治疗组和对照组各40例，治疗前后分别评定患者的AMS、BI、FIM。结果，治疗前、治疗后、前后差值分别为：AMS得分治疗组38.23±17.88、73.68±27.38、35.45±18.13，对照组42.93±18.75、63.45±19.41、20.53±12.56；BI得分治疗组23.38±15.50、53.13±28.46、29.75±16.01，对照组25.50±17.28、43.63±20.25、18.13±11.80；FIM得分治疗组55.98±16.76、92.78±24.72、36.80±14.97，对照组62.75±14.44、84.50±17.85、21.75±11.62。
统计学分析：各组治疗前后比较，P均为0.000，有统计学意义。治疗前、后两组间的AMS、BI、FIM比较，P＞0.05，无统计学意义；两组间AMS、BI、FIM的差值比较，P均为0.000，有统计学意义。结果说明早期康复介入更有利于SCI患者功能的恢复。
3、康复治疗的研究结果：
本研究对100例患者进行临床对照研究，把因各种原因未能进行康复治疗的50例患者与在临床治疗的同时进行系统康复的50例患者分为对照组和治疗组，治疗前后分别评定患者的AMS、BI、FIM。结果，治疗前、治疗后、前后差值分别为：AMS得分治疗组35.14±16.77、72.64±23.44、37.50±20.81，对照组37.87±19.01、44.92±20.36、7.05±3.95；BI得分治疗组18.50±14.22、56.80±26.45、38.30±18.34，对照组22.40±15.79、29.60±18.95、7.20±4.54：FIM得分治疗组55.88±7.79、94.50±19.75、38.62±18.09，对照组58.24±9.83、67.60±11.18、9.36±3.70。
统计学分析：比较两组间的AMS、BI、FIM得分情况，采用独立样本t检验。结果，治疗前治疗组和对照组的AMS、BI、FIM的t值分别为-0.762、-1.298、-1.330，P值分别为0.448、0.197、0.187，无统计学意义。治疗后两组AMS、BI、FIM得分以及AMS前后差值、BI前后差值、FIM前后差值的t值分别为5.911～11.640，P值为0.000，均有统计学意义。说明康复治疗能明显改善SCI患者运动功能和日常生活活动能力(ADL)。
4、心理治疗的结果：
(1) SCI患者心理状态及相关因素分析：
选取120例SCI患者，进行心理状况的评定，以HAMD、BDI评定患者的抑郁状态，HAMD评定患者的焦虑状态，AMS、BI、FIM评定患者的功能状态。
结果：有抑郁者112例，占93.33％；有明显焦虑(＞21分)和严重焦虑(＞29分)者115例，占95.83％。说明SCI患者普遍存在抑郁和焦虑情绪。
抑郁状态的相关因素：HAMD评分与年龄、性别、损伤平面的Pearson相关系数分别为-0.003、0.008、-0.046，无统计学意义，与ASIA、AMS、BI、FIM的相关系数分别为-0.780、-0.308、-0.540、-0.407，有统计学意义；BDI评分与年龄、性别、损伤平面的Pearson相关系数分别为0.014、-0.034、-0.122，无统计学意义，与ASIA、AMS、BI、FIM的Pearson相关系数-0.673、-0.433、-0.548、-0.429，有统计学意义。说明抑郁状态评分与年龄、性别、损伤平面无关，与ASIA分级和患者的功能状态(AMS、BI、FIM)相关。
焦虑状态的相关因素：HAMA评分与年龄、性别的Pearson相关系数分别为0.010、-0.049，无统计学意义，与损伤平面、ASIA、AMS、BI、FIM的Pearson相关系数-0.887、-0.281、-0.524、-0.639、0.559，有统计学意义。说明焦虑状态评分与年龄、性别无关，与损伤平面、ASIA分级和患者的功能状态(AMS、BI、FIM)相关。
(2)心理治疗对心理状态影响的结果：
对120例SCI患者，根据分组原则和程序分为对照组和治疗组各60例，治疗组增加心理治疗(合理情绪疗法)，应用HAMD、BDI、HAMA评估患者的心理状态。治疗前后结果：HAMD治疗组35.53±8.83、18.43±4.85，对照组36.43±8.90、32.17±9.28；BDI治疗组21.77±5.35、10.65±4.02，对照组23.63±4.97、18.95±5.41；HAMA治疗组39.17±8.57、20.90±6.35，对照组38.53±8.87、34.17±9.04。
统计学分析：采用独立样本t检验，比较分析两组间的HAMD、BDI、HAMA得分情况：治疗前HAMD、BDI、HAMA的t值分别为-0.556、-1.979、0.398，P值分别为0.579、0.055、0.691，无统计学意义；治疗后HAMD、BDI、HAMA的t值分别为-10.179、-9.542、-9.300，P值均为0.000，有统计学意义；两组HAMD、BDI、HAMA治疗前后差值比较，t值分别为-16．289、-8.439、-14.639，P值均为0.000，有统计学意义。说明合理情绪疗法可明显改善脊髓损伤患者的心理状态。
(3)心理治疗对运动功能的结果：
采用AMS、BI、FIM对两组病人治疗前后的运动功能进行评定，以研究心理治疗在改善SCI患者心理状态的同时，对其运动功能的影响。结果：①治疗前后治疗组的AMS分别为34.58±16.47，72.65±23.52，对照组分别为40.51±18.25，56.13±22.40；②治疗前后治疗组的BI分别为18.00±13.78，58.50±26.99，对照组分别为23.92±17.90，42.08±22.20；③治疗前后治疗组的FIM分别为55.38±8.02，95.23±20.04，对照组分别为59.77±13.87，78.73±15.65。
统计学分析：采用独立样本t检验，比较分析两组间的AMS、BI、FIM得分情况：治疗前AMS、BI、FIM比较的t值分别为-1.867、-2.029、-2.119，P值分别为0.064、0.072、0.076，无统计学意义；治疗后AMS、BI、FIM比较的t值分别为3.941、3.639、5.027，P值均为0.000，有统计学意义；③两组AMS、BI、FIM治疗前后差值比较，t值分别为7.514、7.300、7.566，P值均为0.000，有统计学意义。说明合理情绪疗法可明显改善脊髓损伤患者的功能状态，提高他们的ADL能力。
结论
1、日常生活活动能力评定量表(AMS)具有良好的信度和效度，在临床上能够广泛应用于脊髓损伤患者ADL的评定；
2、早期康复介入能明显促进脊髓损伤功能的恢复，康复应尽量在伤后1个月之内介入；
3、康复治疗对脊髓损伤的功能恢复具有重要作用；
4、脊髓损伤患者普遍存在抑郁和焦虑情绪，合理情绪疗法能明显改善脊髓损伤患者心理状态，从而促进患者功能状态的恢复。
本研究创新之处：
1、在国内外率先把合理情绪疗法应用于脊髓损伤的心理治疗。RET是心理治疗的一个重要的治疗方法，根据RET的心理学原理和治疗理念，分析SCI后患者的心理特征，RET作为心理治疗方法对SCI患者的心理障碍确实具有针对性。目前，虽然国内外有不少关于RET的研究，但把RET方法应用于疾病的临床研究较少，特别是应用于SCI的心理治疗未见报道。
2、制定了日常生活活动能力评定量表(AMS)并证明了其具有较高的信度和效度，可以推广应用，能够广泛用于脊髓损伤患者ADL的评定。在康复评定的研究上，目前国内尚无统一的日常生活活动能力的评定量表，不便于多中心的合作研究以及学术交流，因此根据国际上通用的有关日常生活活动能力的评定量表，结合国内的实际及文化背景，制定国内统一的日常生活活动能力评定量表，具有重要的意义。
3、双盲、随机对照的研究方法是临床研究的权威研究设计，本研究在国内首次采用双盲、随机分组对照设计方案对脊髓损伤的康复开展临床研究。康复治疗对于SCI患者的功能恢复具有重要意义，但国内众多的有关SCI康复的研究报道，基本上都是自身前后对照，缺乏随机分组对照研究，更没有设盲；对于早期康复介入的时机，缺乏统一的标准，因此研究结果说服力不强。本研究在国内首次采用双盲、随机分组对照设计的临床研究，证明了康复治疗对SCI的功能恢复具有重要的影响，特别是早期康复，应该在1个月之内介入，对SCI患者的的功能结局更为有利。
Objective: There are several aspects of rehabilitation of spinal cord injury to discuss in this study:①Activity of daily living measure scale(AMS) was established to suit the people cultural context and actual of China. The reliability and validity of AMS was analysed, in order to prove that the AMS can apply on clinic widely;②The rehabilitation involvement opportunity was conducted with the groups comparison, in order to clear further about the opportunity of early rehabilitation involvement as well as the influence of early rehabilitation on the function of patients with SCI;③Through the clinical comparison research, the vital role of the rehabilitation treatment which restores to function of patients with SCI was proved;④The influence of Rational-Emotive Therapy(RET) on the psychologic and functional condition of the patients with SCI.
Object and method: 180 cases patients with spinal cord injury in orthopedics or rehabilitation department in hospital during September 2004 to September 2006 was involved in this study. The partial patients left the hospital still persist in the original rehabilitation program until this research is over. This research duration is 3 months.
Study design: Doulbe-blinded, two groups randomized controlled trial, with pretreatment and posttreatment measures.
Setting: Rehabilitation clinics.
Measure contents: The follow measurement were taken in this study: Patient's general condition, damage plane, ASIA grade, Activities of daily living Measure Scale (AMS), Barthel index (BI), Functional independence measure(FIM), Hamilton depression rating scale(HAMD), Hamilton anxiety rating scale(HAMA), Beck depression inventory (BDI).
Measure methods: All SCI patients integrated in this research were evaluated with above measures pre and post rehabilitation treatment. Rehabilitation assessmet were carried on by rehabilitation doctor, physical therapist (PT), psychological therapist (ST). The measure method and attention notes of rehabilitaion assessment was trained to guarantee the measure standard uniformity and the data reliability.
The rehabilitation treatment program was carried on according to different clinical stage of patient; Rational-Emotive Therapy (RET) was taken in psychotherapy to the patients with SCI.
Results:
1、Reliability and validity analysis of the AMS: The reliability and validity of AMS was analysised by Pearson related analytic method of SPSS12.0 statistics software in 30 cases patients with SCI. The AMS scores is consist of movement score (AM), cognition score (AC), total score (AT).
(1) Intergroup reliability: the AMS scores of two times measured by the identical observer within a week-long was analysis: The Pearson correlation coefficient between AM1 and AM2, AM1 and AT2, AC1 and AC2, AT1 and the AM2 is respective 0.999, 0.983, 0.982, 0.992, 0.992. It showed that the relation between the scores of two times measured by the identical observer is high. It demonstrated that AMS has good inter-group reliability.
(2) Between-groups reliability: The AM,AC,AT scores measued by a observer(A) was compared with another observer(B) by Pearson relation. The Pearson correlation coefficient between AM(A) and AM(B), AM(A) and AT(B), AC(A) and AC(B), AT(A) and AM(B), AT(A) and AT(B) is respective 0.999, 0.991, 0.964, 0.992, 0.999. The results showed highly relations of the scores between two observers. It demonstrated that the AMS has good between-groups reliability.
(3) Face validity: Expert's appraisal believed that the content and structure this measure scale are reasonable, the clause in the table can reflect the basic characteristic to SCI patient's functional condition. It shows that the AMS has the good face validity and the research of rehabilitation assessment on SCI measured by AMS can achieve the anticipated target.
(4) Criteria validity: The correlation analysis AMS and FIM and BI was carried on pre and post treatment by pearson relation. The Pearson correlation coefficient of AM1 and FM1, AM1 and FT1, AM1 and BI1, AT1 and FM1, AT1 and FT1, AT1 and BI1 is respective 0.900, 0.880, 0.924, 0.880, 0.854, 0.903 pre treatment; The Pearson correlation coefficient of AM2 and FM2, AM2 and FT2, AM2 and BI2, AT2 and FM2, AT2 and FT2, AT2 and the BI2 is respective 0.825, 0.840, 0.788, 0.828, 0.846, 0.790 post treatment. It is showed that AMS is relative highly with FIM and the BI and has good criteria validity.
(5) Sensitivity: The AMS scores(67.57±14.38) of post treatment is significant improved comparing with the scores(33±16.02) pre treatment (t=12.36, p=0.000). It shows that the sensitivity of AMS is good. Moreover the effect size statistics was used to evaluate the sensitivity of AMS. The effect size is 2.16 and shows that AMS has big effect. Thus the sensitivity of AMS is good.
2、The results of involvement opportunity of rehabilitation treatment on SCI:
According to the forecited grouping principle and the procedure, 80 cases patients with SCI were divided into two groups. 40 cases rehabilitation treatment involved within 1 month after the wound were divided into the treatmet group(TG). 40 cases rehabilitation treatment involved late to 1 month after the wound were devided into the control groupCG). AMS, BI, FIM were measured pre and post treatment. The AMS scorse pre treatment, post treatment, improved value is respective, TG38.23±17.88, 73.68±27.38, 35.45±18.13, CG42.93±18.75, 63.45±19.41, 20.53±12.56; BI scores is: TG 23.38±15.50, 53.13±28.46, 29.75±16.01, CG 25.50±17.28, 43.63±20.25, 18.13±11.80; FIM scores is: TG 55.98±16.76, 92.78±24.72, 36.80±14.97, CG 62.75±14.44, 84.50±17.85, 21.75±11.62.
Statistics analysis: The AMS,BI,FIM scores pre treatment of each group is significant difference compared with post treatment(statistics: P=0.000). The AMS, BI, FIM scores pre treatment is non-statistics significance compared between two groups (P＞0.05); AMS, BI, FIM scores post treatment as well as their improved value is statistics significance compared between two groups(P=0.000). The results explanation that earlier rehabilitation involvement is more advantageous to function restoration on the SCI patients.
3、rehabilitation treatment results:
100 patients with SC1 included in this study were divided into two groups. 50 cases who has not been able to treated with rehabilitation treatment because of each kind of reason were divided into control group(CG). 50 cases who were provided rehabilitation treatment were divided into treatment group(TG). AMS, BI, FIM were measured pre and post treatment. The AMS scorse pre treatment, post treatment, improved value is respective: TG 35.14±16.77, 72.64±23.44, 37.50±20.81, CG 37.87±19.01, 44.92±20.36, 7.05±3.95; The BI score: TG 18.50±14.22, 56.80±26.45, 38.30±18.34, CG 22.40±15.79, 29.60±18.95, 7.20±4.54; The FIM score: TG 55.88±7.79, 94.50±19.75, 38.62±18.09, CG 58.24±9.83, 67.60±11.18, 9.36±3.70.
Statistics analysis: AMS, BI, F1M score were compared between two groups by the independent sample t-test. The AMS, BI, FIM of pre treatment is non-statistics significance difference compared between TG and CG (t: -0.762, -1.298, -1.330; P 0.448, 0.197, 0.187). AMS, BI, FIM scores post treatment as well as their improved value is statistics significance difference compared between two groups(t=5.911～11.640; P=0.000). It explains rehabilitation treatment can improve the SCI patient movement function and ability of daily life (ADL) obviously.
4、psychology treatment results:
(1) SCI patient's psychology and correlation factors analysis:
120 SCI patients were involved in this study. Depression was evaluated by HAMD, BDI and anxious condition was evaluated by HAMA. AMS, BI, FIM were evaluated to functional condition of SCI patients. In 120 cases, 112(93.33%) patients suffered the depression and 115(95.83%) patients suffered obvious anxious (＞21) and serious anxious (＞29). It explains that there is generally depression and anxious in the SCI patients.
Correlation factors to depression: The Pearson correlation coefficient of HAMD score compared with the age, the sex, the course of illness, the damage section is respective -0.003, 0.008, 0.066, -0.046. HAMD score compared with ASIA, AMS, BI, FIM, The Pearson correlation coefficient is respective -0.780, -0.308, -0.540, -0.407. The Pearson correlation coefficient of BDI score compared with the age, the sex, the course of illness, the damage section is respective 0.014, -0.034, 0.160, -0.122. BDI score compared with ASIA, AMS, BI, FIM, the Pearson correlation coefficient is respective -0.673, -0.433, -0.548, -0.429. It explains that depression of SCI patients do not related with the age, the sex, the course of illness, the damage section and is closly relative with ASIA and patient's functional condition (AMS, BI, FIM).
Correlation factors to anxious: The Pearson correlation coefficient of HAMA compared with the age, the sex, the course of illness is respective 0.010, -0.049, 0.146, HAMA compared with the damage section, ASIA,AMS,BI,FIM, the Pearson correlation coefficient is respective -0.887, -0.281, -0.524, -0.639, 0.559. It explains that the anxious of SCI patients do not related with the age, the sex, the course of illness and is relative with the damage section, ASIA and patient's functional condition(AMS, BI, FIM).
(2) Influence of Rational-Emotive Therapy on psychology condition of SCI patients:
120 SCI patients who were treated with rehabilitation program were divided into the control group(CG) 60 cases and treatment group(TG) 60 cases according to the grouping principle and procedure. The patients in treatment group was treated with RET while they were been suffering rehabilitation training. Psychology assessment was evaluated by HAMD, BDI, HAMA. The HAMD scores of pre and post treatment is: TG 35.53±8.83, 18.43±4.85, CG 36.43±8.90, 32.17±9.28; The BDI scores of pre and post treatment is: TG 21.77±5.35, 10.65±4.02, CG 23.63±4.97, 18.95±5.41; The HAMA scores of pre and post treatment is: TG 39.17±8.57, 20.90±6.35, CG 38.53±8.87, 34.17±9.04.
Statistics analysis: The HAMD, BDI, HAMA scores were compared between two groups by the independent sample t-test. The HAMD, BDI, HAMA scores of pre treatment is non-statistics significance difference compared between two groups(t=-0.556, -1.979, 0.398, P=0.579, 0.055, 0.691). The HAMD, BDI, HAMA scores of post treatment and their improved value is statistics significance difference compared between two groups(t=-16.289～-8.439, P=0.000). It explains that Influence of Rational-Emotive Therapy on psychology condition of SCI patients is remarkable.
(3) Influence of Rational-Emotive Therapy on movement function of SCI patients:
AMS, BI, FIM were evaluated in the assessment of movement function and ADL of SCI patients in order to explore the influence of RET on the movement functional condition while psychology condition were improved. Results: The AMS scores of pre and post treatment is respective: TG 34.58±16.47, 72.65±23.52, CG 40.51±18.25,56.13±22.40; The BI scores of pre and post treatment is respective: TG 18.00±13.78, 58.50±26.99, CG 23.92±17.90, 42.08±22.20; The FIM scores of pre and post treatment is respective: TG 55.38±8.02, 95.23+20.04, CG 59.77±13.87, 78.73±15.65.
Statistics analysis: AMS, BI, FIM scores of pre and post treatment were compared between two groups by the independent sample t-test. The AMS, BI, FIM scores of pre treatment is non-statistics significance difference compared between two groups(t=-1.867, -2.029,-0.119, P=0.064, 0.072, 0.076). The AMS, BI, FIM scores of post treatment is statistics significant difference compared between two groups(t=3.941, 3.639, 5.027, P=0.000). The improved value of AMS, BI, FIM is statistics significant difference compared between two groups(t=7.514, 7.300, 7.566, P=0.000). It is indicated that the RET can improve the movement function and ADL of SCI patients while psychology condition were improved.
Conclusions:
(1) There is the good validity and reliability in Activity of daily living measure scale(AMS). It can be widely applied in clinical to evaluate the movement function and ADL of patients with spinal cord injury.
(2) The early rehabilitation involvement can promote the spinal cord injury function restoration, the rehabilitation to be supposed obviously to involve as far as possible within 1 month after the wound.
(3) Rehabilitation treatment has the vital role to restore function of spinal cord injury.
(4) There are depression and anxious generally in patients with spinal cord injury. The Rational-Emotive Therapy can improve psychology condition of the patients with spinal cord injury obviously, thus promotes the patient's function condition restoration.
Innovation place of this study:
1、It takes the lead that the Rational-Emotive Therapy(RET) was applied to the psychotherapy of patients with spinal cord injury. RET is a important method of psychotherapy. According to the psychology principle and the treatment idea of RET and analysed the psychology characteristic of SCI patients, RET truly has pointed as the psychotherapy to the SCI patient's psychological barrier. At present, although there are many research about the RET in domestic and foreign, but applied the RET to the disease clinical research are less, specially applied to the SCI psychotherapy has not seen the report.
2、There is the good reliability and validity in Activity of daily living Measure Scale(AMS) and the widely appling in clinic to evaluate the movement function and ADL of patients with spinal cord injury. At present in domestic, there is not still a unification measure scale to evaluate ADL of SCI patients. It is very inconvenienced to the multi-central cooperation research as well as the academic exchange. Therefore, according to the international general measure scale related ADL, there is the vital significance to establish domestic unification scale of ADL for SCI patients linked to the domestic reality and the cultural context.
3、Doulbe-blinded, randomized controlled trial is the authority clinical study design. Doulbe-blinded, randomized grouping controlled trial was first designed in this study on rehabilitation of patients with SCI in domestic. Rehabilitation treatment is vital significance to improve the function of patients with SCI. But domestic multitudinous research reported of SCI is all basical own around comparing and lacks the grouping randomized controlled comparison, specially not supposed blindly; The opportunity of early rehabilitation involvement lacks the unification standard. Therefore the findings persuasive power is not strong. Doulbe-blinded, randomized grouping controlled trial was first designed in this study on rehabilitation of patients with SCI in domestic. The results show that the influence of rehabilitation treatment on the function of patients with SC1 is important, specially for the early rehabilitation involvement. The early rehabilitation should involving within 1 month and has more advantageous to functional outcome of patients with SC1.
引文
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