Weight-bearing Exercise for Trans-tibial Amputees

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-14

Study Completion Date

2021-12-31

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).

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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.

Conditions

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Amputation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test group

additional weight-bearing exercise

Group Type EXPERIMENTAL

additional weight-bearing exercise

Intervention Type BEHAVIORAL

Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure

Control group

standard weight-bearing exercise

Group Type ACTIVE_COMPARATOR

standard weight-bearing exercise

Intervention Type BEHAVIORAL

conventional training for fitting of initial prosthesis

Interventions

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additional weight-bearing exercise

Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure

Intervention Type BEHAVIORAL

standard weight-bearing exercise

conventional training for fitting of initial prosthesis

Intervention Type BEHAVIORAL

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.