Weight-bearing Training Exercise May Improve Loading of Trans-tibial Prosthesis and Functional Gait
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Change in centre of pressure (COP) from baseline
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Test group
additional weight-bearing exercise
Intervention: additional weight-bearing exercise (Behavioral)
Control group
standard weight-bearing exercise
Intervention: standard weight-bearing exercise (Behavioral)
Outcomes
Primary Outcomes
Change in centre of pressure (COP) from baseline
Time Frame: Assessment at baseline and after two weeks
Calculation of COP (transversal plane, symmetry index, lateral, sagittal directions) from 4 pressure sensors built into the balance board
Change in weight distribution in quiet standing
Time Frame: Assessment at baseline and after two weeks
COP assessment for 20s of quiet standing
Secondary Outcomes
- Change in 10m walk test(Assessment at baseline and after two weeks)
- Change in L-test(Assessment at baseline and after two weeks)