Weight-bearing Exercise for Trans-tibial Amputees

Study Overview
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Brief Summary
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A simple weight-bearing exercise has been designed using off-the-shelves devices (Nintendo Wii Balance Board) and centre of pressure (COP) analysis software (Python) for trans-tibial amputees receiving their first prosthesis. A pilot randomised control study will be conducted to check the progress with weight-bearing training using COP-based objective measures. Additionally, gait and functional task performance will be assessed by means of clinical test. Participants will be divided into 2 groups: test group (performing additional weight-bearing exercises) and control group (receiving only conventional training for fitting of initial prosthesis).

Detailed Description
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Each patient meeting the inclusion criteria will be randomised to either the test group or the control group. The patients will perform ten training sessions with the initial prosthesis, each session lasting for about 30 minutes, within the period of two weeks. They will be assessed at baseline and after the training program.

Official Title
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Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait

Conditions
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Amputation

Intervention / Treatment
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* Behavioral: additional weight-bearing exercise
* Behavioral: standard weight-bearing exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: trans-tibial amputation, fitted with first trans-tibial prosthesis, independent mobility for 50m with or without assistive aid, Functional Independence Measure (FIM) Stairs locomotion scale ≥ 5, ability to follow the instructions, Mini Mental State Examination (MMSE) > 25, no severe visual problems, ble to see computer screen, willing to participate. Exclusion Criteria: bilateral lower limb amputation or any other level of unilateral lower limb amputation, not candidates for prosthetic fitting.

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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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 |
| --- | --- |
| Experimental: Test group<br>additional weight-bearing exercise | Behavioral: additional weight-bearing exercise<br>* Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure<br>|
| Active Comparator: Control group<br>standard weight-bearing exercise | Behavioral: standard weight-bearing exercise<br>* conventional training for fitting of initial prosthesis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in centre of pressure (COP) from baseline | Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board | Assessment at baseline and after two weeks | 
| Change in weight distribution in quiet standing | COP assessment for 20s of quiet standing | Assessment at baseline and after two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10m walk test |  | Assessment at baseline and after two weeks | 
| Change in L-test |  | Assessment at baseline and after two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balance, trans-tibial prosthesis, weight-bearing, centre of pressure