Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning

November 16, 2015 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Impact of Exercise Medicine on Lower Limb Amputees According to the Three Domains of the International Classification of Functioning

The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF).

The investigators want to determine benefits of exercise medicine on all of these domains.

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Belgium
      • Bruxelles, Belgium, 1200
        • Recruiting
        • Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc

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:

  • unilateral lower limb amputation
  • amputees with prothesis
  • after learning how to walk with the prothesis
  • walking with or without technical aids

Exclusion Criteria:

  • previous exercise training

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physiotherapy
Comparing the patients to themselves (spontaneus evolution) before intervention.
Other: Physiotherapy
Physiotherapy three times a week for 8 weeks according to a well-defined protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in 6 minutes walk test
Time Frame: at -1, 0, 2 and 4 mounths
at -1, 0, 2 and 4 mounths

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Timed Up and Go
Time Frame: at -1, 0, 2 and 4 mounths
at -1, 0, 2 and 4 mounths
Change in Satisfaction towards prothesis questionnaire (SAT-PRO)
Time Frame: at -1, 0, 2 and 4 mounths
questionnaire
at -1, 0, 2 and 4 mounths
Change in Flexibility test
Time Frame: at -1, 0, 2 and 4 mounths
measurement of distance between fingers and floor
at -1, 0, 2 and 4 mounths
Change in Isokinetic strength testing
Time Frame: at -1, 0, 2 and 4 mounths
at -1, 0, 2 and 4 mounths
Change in Prosthetic Profile of the Amputee
Time Frame: at -1, 0, 2 and 4 mounths
at -1, 0, 2 and 4 mounths

Collaborators and Investigators

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

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Gilles Caty, Cliniques universitaires Saint-Luc

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

June 1, 2014

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

July 10, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 21, 2014

Study Record Updates

Last Update Posted (Estimate)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EMA001
  • 2014/09AVR/175 (Other Identifier: StLuc)

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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