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

NCT ID: NCT02297295

Last Updated: 2015-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Lower Limb Amputees

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Physiotherapy

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

Group Type EXPERIMENTAL

Physiotherapy

Intervention Type OTHER

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

Interventions

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Physiotherapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilles Caty

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Gilles Caty

Role: CONTACT

[email protected]
003227641650

Other Identifiers

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2014/09AVR/175

Identifier Type: OTHER

Identifier Source: secondary_id

EMA001

Identifier Type: -

Identifier Source: org_study_id