Weight-bearing Exercise for Trans-tibial Amputees (Prototest)

January 26, 2022 updated by: University Rehabilitation Institute, Republic of Slovenia

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
      • Ljubljana, Slovenia, 1000
        • University Rehabilitation Institute, Republic of Slovenia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test group
additional weight-bearing exercise
Behavioral: additional weight-bearing exercise
Nintendo Wii Balance Board, real-time visual feedback, weight-bearing assessment by center of pressure
Active Comparator: Control group
standard weight-bearing exercise
Behavioral: standard weight-bearing exercise
conventional training for fitting of initial prosthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Assessment at baseline and after two weeks
Change in weight distribution in quiet standing
Time Frame: Assessment at baseline and after two weeks
COP assessment for 20s of quiet standing
Assessment at baseline and after two weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in 10m walk test
Time Frame: Assessment at baseline and after two weeks
Assessment at baseline and after two weeks
Change in L-test
Time Frame: Assessment at baseline and after two weeks
Assessment at baseline and after two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Rehabilitation Institute, Republic of Slovenia

Collaborators

Slovenian Research Agency

Investigators

  • Study Chair: Helena Burger, MD, PhD, University Rehabilitation Institute, Republic of Slovenia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

October 14, 2021

First Submitted That Met QC Criteria

October 14, 2021

First Posted (Actual)

October 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 27, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • URIS202102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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