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

Lower Limb Amputees Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02297295
• Other study ID #: EMA001
• Secondary ID: 2014/09AVR/175
• Status: Recruiting
• Phase: N/A
• First received: July 10, 2014
• Last updated: November 16, 2015
• Start date: June 2014
• Est. completion date: December 2016

Study information

• Verified date: November 2014
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Gilles Caty
• Phone: 003227641650
• Email: gilles.caty[@]uclouvain.be
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Lower Limb Amputees

Intervention

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

Locations

Country	Name	City	State
Belgium	Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc	Bruxelles

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 6 minutes walk test		at -1, 0, 2 and 4 mounths	No
Secondary	Change in Timed Up and Go		at -1, 0, 2 and 4 mounths	No
Secondary	Change in Satisfaction towards prothesis questionnaire (SAT-PRO)	questionnaire	at -1, 0, 2 and 4 mounths	No
Secondary	Change in Flexibility test	measurement of distance between fingers and floor	at -1, 0, 2 and 4 mounths	No
Secondary	Change in Isokinetic strength testing		at -1, 0, 2 and 4 mounths	No
Secondary	Change in Prosthetic Profile of the Amputee		at -1, 0, 2 and 4 mounths	No