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Weight-bearing Exercise for Trans-tibial Amputees

NCT05095805 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-27

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Slovenian Research Agency

    collaborator OTHER

  • University Rehabilitation Institute, Republic of Slovenia

    lead OTHER

Principal Investigators

  • Helena Burger, MD, PhD · University Rehabilitation Institute, Republic of Slovenia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-14
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05095805 on ClinicalTrials.gov