Treadmill Training With Lower Extremity Amputees

Study Overview
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Brief Summary
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Many people with a leg amputation have difficulty walking even after they have finished their rehabilitation. The purpose of this study is to see if a large amount of walking practice on a treadmill can improve functional abilities.

Conditions
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Traumatic Amputation of Lower Extremity

Intervention / Treatment
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* Other: Treadmill Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Leg amputation that is either below the knee, through the knee, or above the knee Ability to walk with prosthetic Comfortably fitted with a prosthesis for at least 6 months Not currently receiving physical therapy for gait training Able to tolerate a moderate intensity exercise program Exclusion Criteria: People with severe cardiac or pulmonary disease that limits ability to exercise. People with too much discomfort and/or pain that restricts their ability to walk. People with active wounds on their residual limb or contralateral foot. People who weigh more than 360lbs or are taller than 6'11 as the unweighing system can not support any greater load or height.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: No Body weight support<br> | Other: Treadmill Training<br>* The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.<br>|
| Experimental: Body weight support<br> | Other: Treadmill Training<br>* The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in 6-minute walk test | Participants will be assessed 3 times: Baseline, 1 week after completing the training protocol, and then 1 month after completing the training protocol | Baseline, after training, 1 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amputees