Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients

NCT ID: NCT00570570

Last Updated: 2015-08-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-12-31

Brief Summary

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Gait impairment remain one of the main problem for hemiplegic stroke patients. After the 6 first months, stroke patients are classically described with moderate or no improvement. Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way.

Detailed Description

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Gait impairment remain one of the main problem for most of chronic hemiplegic stroke patients. After the 6 first months, stroke patients are classically described with moderate or no improvement for motor skills. However, physiothertapy is very often delivered to try to increase motor performance. Here, we want to compare the effectiveness of a flexor and extensor paretic knee muscular strengthening program with conventional physiotherapy delivered by the local physiotherapist of the patient, in a very ecological way. Patients will be randomly affected to one group with the same amount of physiotherapy (at least 3 times weekly for 6 weeks). Assessment will be done blindly by another physiotherapist, before, after the 6-week treatment and 6 weeks later to evaluate immediate and remaining benefits of each treatment.

Conditions

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Hemiplegia Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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group 1

Muscular Strengthening for paretic knee flexor and extensor

Group Type OTHER

Muscular Strengthening for paretic knee flexor and extensor

Intervention Type PROCEDURE

thrice a week during 6 weeks

group 2

conventional physiotherapy

Group Type ACTIVE_COMPARATOR

conventional physiotherapy

Intervention Type OTHER

trice a week during 6 weeks

Interventions

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Muscular Strengthening for paretic knee flexor and extensor

thrice a week during 6 weeks

Intervention Type PROCEDURE

conventional physiotherapy

trice a week during 6 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Hemipegia due to ischaemic or hemorrhagic stroke more than 6 months ago
* 1st and unique cerebral lesion (Xscan or MRI)
* ability to walk 15 m with or without cane or crutch
* able to understand and give approved consent
* quadriceps at 3/5 (MRC) or stronger

Exclusion Criteria

* Current treatment with botulinum toxin for spasticity of the paretic flexor or extensor of the knee
* Cardiovascular disease contra-indicating effort and strengthening
* Pregnancy
* Evolving pathology
* Rheumatic disease of the knee contraindicating strengthening
* Aphasia with severe comprehension impairment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role collaborator

University Hospital, Limoges

OTHER

Sponsor Role collaborator

University Hospital, Toulouse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xavier D de Boissezon

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

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Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié

Albi, , France

Site Status

Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,

Bordeaux, , France

Site Status

Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,

Limoges, , France

Site Status

Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat

Salies-du-Salat, , France

Site Status

Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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PHRC

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

07 020 08

Identifier Type: -

Identifier Source: org_study_id

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