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Completed

NCT Number: NCT05095805

Weight-bearing Exercise for Trans-tibial Amputees

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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Key information

Conditions

Amputation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Rehabilitation Institute, Republic of Slovenia

Ljubljana, 1000, Slovenia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

additional weight-bearing exercise

Behavioral

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

standard weight-bearing exercise

Behavioral

conventional training for fitting of initial prosthesis

Primary outcomes

  1. 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

  2. Change in weight distribution in quiet standing

    Time frame: Assessment at baseline and after two weeks

    COP assessment for 20s of quiet standing

Secondary outcomes

  1. Change in 10m walk test

    Time frame: Assessment at baseline and after two weeks

  2. Change in L-test

    Time frame: Assessment at baseline and after two weeks

Sponsors and collaborators

Lead sponsor

University Rehabilitation Institute, Republic of Slovenia

Other

Collaborators

  • Slovenian Research Agency

Registry information

Official study title

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

Acronym: Prototest

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2021
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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