Effects of Walking Training on Different Surfaces on Walking Ability in Ambulatory Patients With Spinal Cord Injury

Study Overview
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Brief Summary
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The study compares effects of 4-week walking training program on a walking track with difference surface [WTDS] and a firm ground on functional ability of ambulatory individuals with incomplete spinal cord injury [iSCI], using within- and between-group comparisons.

Official Title
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Effects of Walking Training on Different Surfaces on Walking Ability, Balance Control, Lower Limb Muscle Strength, and Falls in Ambulatory Patients With Spinal Cord Injury

Conditions
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Spinal Cord Injuries, Rehabilitation

Intervention / Treatment
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* Other: Rehabilitation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 18 years Having an incomplete SCI (the American Spinal Cord Injury Association (ASIA) Impairment Scale or AIS C or D) (Kirshblum et al., 2011) At a sub-acute or chronic stage of injury (post injury time: PIT > 3 months) (Wirth et al., 2008; Blackwell et al., 2001) Able to walk with or without a walking device for at least 10m (Behrman et al., 2005; Lam et al., 2008; Jackson et al., 2008) Having a body mass index (BMI) between 18.5-29.9 kg/m2 (Woo et al., 2007) Exclusion Criteria: Having an SCI from a progressive disease such as multiple sclerosis or malignancy Having other medical conditions that might affect ambulatory ability, such as pain in the musculoskeletal system with an intensity of pain more than 5 out of 10 on a numeric rating pain scale (Dijkers, 2010), deformities of the spine and lower extremities (i.e. scoliosis, kyphosis, and equinovarus) and other neurological or other medical disorders (thromboembolism, autonomic dysreflexia). Severe spasticity of the lower extremities (Modified Ashworth Scale (MAS) more than 2) (Bohannon & Smith, 1987; Scivoletto et al., 2008).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Different surfaces<br>Subjects are trained to walk over a walking track with different surfaces (WTDS) for 5 days over 4 weeks. | Other: Rehabilitation therapy<br>* Subjects are trained to walk overground (control) or over WTDS (experimental) for 5 days/week over 4 week. Then they will be monthly follow-up for fall data.<br>* Other names: Walking training;|
| Active Comparator: overground<br>Subjects are trained to walk overground for 5 days over 4 weeks. | Other: Rehabilitation therapy<br>* Subjects are trained to walk overground (control) or over WTDS (experimental) for 5 days/week over 4 week. Then they will be monthly follow-up for fall data.<br>* Other names: Walking training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter walk test (10MWT) | Subjects walk at a comfortable pace along a 10m walkway. The test records the time use over the middle 4m of the walkway in order to minimize acceleration and deceleration effects. Then the average time over the 3 trials is converted to walking speed using the formula v=distance (m) /time (s) | Change over 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed up and go test (TUGT) | Subjects stand up from a standard armchair, walk around a traffic cone that is located 3m away from the chair, and return to sit down on the chair at a maximum and safe speed. The test records the time taken from the command Go until the subject's back against the backrest of the chair. Then the average times finding over the 3 trials is used for data analysis. | Change over 4 weeks | 
| Five times sit-to-stand test (FTSST) | The time taken to complete 5 chair-rise cycles at a fastest and safe speed is measured for each subject. Then the average time over the 3 trials is used for data analysis. | Change over 4 weeks | 
| 6-minute walk test (6MWT) | Subjects walk along a rectangular walkway as long as possible in 6 minutes. Every minute during the test, they are informed the time left and encouraged to continue in a good manner. Subjects are able to take a period of rest as needed and continued walking as soon as they can. The distance covered after 6 minutes are recorded | Change over 4 weeks | 
| Incidence of fall | Then subject will be monthly monitored for the fall data during 6 months using a fall diary and telephone. | Six months after completing the training program. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Walking, Spinal cord injury, Rehabilitation, Surfaces