Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients

Study Overview
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Brief Summary
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The purpose of this current prospective study is to assess the effects of body weight support treadmill training (BWSTT) in individuals with spinal cord injury (SCI). Training intervention aim at improving: quality of life, walking capability, spasticity, functions in every day life, bone mass density and related hematological factors. The examination consisted of (1) neurological classification by ASIA standard neurological classification of spinal cord injury working sheet, (2) spasticity evaluation of lower limbs by Modified Ashworth Scale, (3) walking independence evaluation by Walking Index for Spinal Cord Injury II (WISCI II), (4) patient's quality of life perspective by World Health Quality of Life- BREF (WHOQOL-BREF), (5) the functional status by 10-item Modified Barthel Index, (6) bone mass density (BMD) by Dual-energy X-ray absorptiometry (DXA) scan, (7) body tissue consistency by full body DXA scan, (8) skeletal system health associated blood factors (calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone) by hematological tests. The results will be collected and evaluated using statistical software (i.e. SPSS).

Official Title
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Body Weight Supported Treadmill Training as Physical Therapy Treatment to Spinal Cord Injury Patients

Conditions
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Spinal Cord Injury/Damage

Intervention / Treatment
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* Procedure: BWSTT (3 days a week for maximum of 20 minutes session)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SCI ASIA classification B, C or D clinical stable Exclusion Criteria: unstable cardiac conditions epilepsy autonomic dysreflexia significant musculoskeletal problems in lower extremities other than SCI Parkinson's disease

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 88 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BWSTT (3 days a week for maximum of 20 minutes session)<br>BWSTT (20 minutes of treadmill training (velocity (≥0.1km/h) and body weight support (≤40% of patients weight) according to patients capability and comfort | Procedure: BWSTT (3 days a week for maximum of 20 minutes session)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WISCI II | Change of walking independence at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASIA standard neurological classification for spinal cord injury patients working sheet | Change of neurological impairment status at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 
| Modified Ashworth scale | Change of spasticity of leg muscles at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 
| WHOQOL-BREF | Change of patients' perspective of life quality at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 
| 10-item Modified Barthel Index | Change of function at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 
| DXA scan | Change of BMD of hip and spine at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 
| Full Body DXA scan | Change of body tissue consistency at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks | 
| Hematological analysis | Change of blood's calcitonin, osteocalcin, 25 OH vitamin D, 1,25- (OH)2 vitamin D, ostase and parathyroid hormone concentrations at six weeks | At the time of Admittance to the rehabilitation department (at baseline) and after six weeks |