Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study

Study Overview
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Brief Summary
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The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.

Detailed Description
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Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.

Official Title
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Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study

Conditions
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Motor-incomplete Spinal Cord Injury

Intervention / Treatment
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* Behavioral: Body-weight supported treadmill training
* Behavioral: Body-weight supported treadmill training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago 19 to 65 years of age use of standing or walking as part of typical activities of daily living controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study Exclusion Criteria: lesion below 11th thoracic level (lower motoneuron injury) weight greater than 300 lbs or height greater than 6'1 femur length <35 cm or >47 cm and body weight >150 kg cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30) participation in rehabilitation therapy or other research study with exercise or mobility outcomes

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking. | Behavioral: Body-weight supported treadmill training<br>* BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.<br>|
| Experimental: 2<br>One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking. | Behavioral: Body-weight supported treadmill training<br>* BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average activity level per day measured before, after, 1-month after, and 6-months after training |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord injury, walking, gait training, body-weight supported treadmill training, rehabilitation