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

Not Applicable

• Conditions: Lower Limb Amputees
• Interventions: Other: Physiotherapy

• Registration Number: NCT02297295
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

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 Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-07-10
• Status Verified: 2014-11
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-21
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17
• Primary Completion: 2016-10
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Physiotherapy	Physiotherapy	Comparing the patients to themselves (spontaneus evolution) before intervention.

Primary Outcome Measures

Name	Time	Method
Change in 6 minutes walk test	at -1, 0, 2 and 4 mounths

Secondary Outcome Measures

Name	Time	Method
Change in Isokinetic strength testing	at -1, 0, 2 and 4 mounths
Change in Flexibility test	at -1, 0, 2 and 4 mounths	measurement of distance between fingers and floor
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	questionnaire
Change in Prosthetic Profile of the Amputee	at -1, 0, 2 and 4 mounths

Trial Locations

Locations (1)

Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium