Impact of Exercise Medicine on Lower Limb Amputees Accord... | NCT02297295

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

NCT02297295

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status

Unknown status

Last Update Posted

Nov 17, 2015Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Lower Limb Amputees

Interventions

Physiotherapy

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014/09AVR/175	Other Identifier	StLuc

Status Module

Record Verification Date

Nov 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Oct 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Jul 10, 2014

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2015

Last Update Posted Date

Nov 17, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physiotherapy	Experimental	Comparing the patients to themselves (spontaneus evolution) before intervention.	Other: Physiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physiotherapy	Other	Physiotherapy three times a week for 8 weeks according to a well-defined protocol	Physiotherapy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Change in Timed Up and Go		at -1, 0, 2 and 4 mounths
Change in Satisfaction towards prothesis questionnaire (SAT-PRO)	questionnaire	at -1, 0, 2 and 4 mounths

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Gilles Caty	Contact	003227641650		gilles.caty@uclouvain.be

Overall Officials

Name	Affiliation	Role
Gilles Caty	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de médecine physique et réadapation des Cliniques Universitaires Saint-Luc	Recruiting	Brussels		1200	Belgium

Intervention Browse Module

MeSH Terms

ID	Term
D026741	Physical Therapy Modalities

Ancestor Terms

ID	Term
D013812	Therapeutics
D012046	Rehabilitation

Browse Leaves

Not provided

Browse Branches

Not provided