Weight-bearing Exercise for Trans-tibial Amputees

Amputation Clinical Trial

— Prototest  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095805
• Other study ID #: URIS202102
• Status: Completed
• Phase: N/A
• Start date: October 14, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2022
• Source: University Rehabilitation Institute, Republic of Slovenia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Amputation

Intervention

Behavioral:
• additional weight-bearing exercise
Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
• standard weight-bearing exercise
conventional training for fitting of initial prosthesis

Locations

Country	Name	City	State
Slovenia	University Rehabilitation Institute, Republic of Slovenia	Ljubljana

Sponsors (2)

Lead Sponsor	Collaborator
University Rehabilitation Institute, Republic of Slovenia	Slovenian Research Agency

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in weight distribution in quiet standing	COP assessment for 20s of quiet standing	Assessment at baseline and after two weeks
Secondary	Change in 10m walk test		Assessment at baseline and after two weeks
Secondary	Change in L-test		Assessment at baseline and after two weeks