NCT02297295

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 10, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2014

Enrollment Period

2.3 years

First QC Date

July 10, 2014

Last Update Submit

November 16, 2015

Conditions

Lower Limb Amputees

Keywords

Sequelae of; Amputation, Traumatic, Limb, Lower

Outcome Measures

Primary Outcomes (1)

  • Change in 6 minutes walk test

    at -1, 0, 2 and 4 mounths

Secondary Outcomes (5)

  • Change in Timed Up and Go

    at -1, 0, 2 and 4 mounths

  • Change in Satisfaction towards prothesis questionnaire (SAT-PRO)

    at -1, 0, 2 and 4 mounths

  • Change in Flexibility test

    at -1, 0, 2 and 4 mounths

  • Change in Isokinetic strength testing

    at -1, 0, 2 and 4 mounths

  • Change in Prosthetic Profile of the Amputee

    at -1, 0, 2 and 4 mounths

Study Arms (1)

Physiotherapy

EXPERIMENTAL

Comparing the patients to themselves (spontaneus evolution) before intervention.

Other: Physiotherapy

Interventions

PhysiotherapyOTHER

Physiotherapy three times a week for 8 weeks according to a well-defined protocol

Physiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • previous exercise training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Gilles Caty

    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gilles Caty

CONTACT

003227641650gilles.caty@uclouvain.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2014

First Posted

November 21, 2014

Study Start

June 1, 2014

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

November 17, 2015

Record last verified: 2014-11

Locations

BE(1)