Weight-bearing Exercise for Trans-tibial Amputees

NCT05095805 | Completed

• 1 other identifier: URIS202102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Amputation

Keywords

trans-tibial prosthesis; weight-bearing; balance; centre of pressure

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in 10m walk test

  Assessment at baseline and after two weeks

• Change in L-test

  Assessment at baseline and after two weeks

Study Arms (2)

Test group

EXPERIMENTAL

additional weight-bearing exercise

Behavioral: additional weight-bearing exercise

Control group

ACTIVE COMPARATOR

standard weight-bearing exercise

Behavioral: standard weight-bearing exercise

Interventions

additional weight-bearing exercise BEHAVIORAL

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

Test group

standard weight-bearing exercise BEHAVIORAL

conventional training for fitting of initial prosthesis

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• bilateral lower limb amputation or any other level of unilateral lower limb amputation,
• not candidates for prosthetic fitting.

Sponsors & Collaborators

• University Rehabilitation Institute, Republic of Slovenia: lead
• Slovenian Research Agency: collaborator

Study Sites (1)

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

Location

Study Officials

• Helena Burger, MD, PhD

  University Rehabilitation Institute, Republic of Slovenia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: October 27, 2021
• Study Start: October 14, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)