Robotic Gait Training VS.Conventional Rehabilitation in SCI

Study Overview
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Brief Summary
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Until now, there's still no any strong evidence supported which is the best way to restoration walking ability in spinal cord injury. Most of the evidence suggest that, there is somehow better after gait rehabilitation for ASIA classification C and D but not improved walking ability for ASIA classification A and B. There is an RCT showed the evidence of repetitive locomotor training and physiotherapy could be improved walking and basic activities of daily living after stroke, these might be also really effect in SCI patients.

Detailed Description
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This study aim to study the effectiveness of conventional rehabilitation compare with robotic gait training machine in subacute SCI patients.

Official Title
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Robotic Gait Training VS. Conventional Physical Therapy in Spinal Cord Injury Patients.

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: Robot gait training
* Other: control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subacute spinal cord injury ( C5-T12 level) patients. ASIA classification C and D. No previous joint contracture. No severely active medical condition. Can easily communicate with no obvious cognitive impairment. Given signed inform consent. Exclusion Criteria: Previous injury or other neurological condition that related to neurodeficit in key muscles.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic gait training<br>conventional physical therapy plus robot gait training program for SCI patients. | Device: Robot gait training<br>* Robotic gait training for 20 minute include preparing and rest time for 10 minute plus conventional physical therapy program for 30 minute, totally 60 minute per day for 5 working day per week.<br>* Other names: Gait trainer GT1;|
| No Intervention: control<br>Conventional physical therapy program for 60 minute per day for 5 working day per week. | Other: control<br>* Conventional physical therapy program for 60 minute per day for 5 working day per week.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wernig scale | Walking ability classification in spinal cord injury patients. | 4 weeks. | 
| Barthel index | Measure activity of daily living | 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repas | Spasticity measurement | 4 weeks. | 
| Manual muscle testing | Measure muscle power in each key muscle according to ASIA classification. | 4 weeks | 
| 10 meter walking test | If patients can walk, measure speed of walking with step length. | 4 weeks. | 
| 6 minute walking test | If patient can walk, measure endurance. | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SCI, gait, rehabilitation, robotic