NCT05095805

Weight-bearing Exercise for Trans-tibial Amputees

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University Rehabilitation Institute, Republic of Slovenia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation

Interventions

Type	Name	Description
BEHAVIORAL	additional weight-bearing exercise	Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
BEHAVIORAL	standard weight-bearing exercise	conventional training for fitting of initial prosthesis

Timeline

• Start date: 2021-10-14
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2021-10-27
• Last updated: 2022-01-27

Locations

1 site across 1 country: Slovenia