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| Sponsor: | University Hospital, Toulouse |
|---|---|
| Collaborators: |
University Hospital, Bordeaux University Hospital, Limoges Rehabilitation center Albi Local Hospital Salies du Salat |
| Information provided by: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00570570 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Hemiplegia Stroke |
Other: Muscular Strengthening for paretic knee flexor and extensor Other: conventional physiotherapy |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Comparaison de l'efficacité du Renforcement Des Muscles fléchisseurs et Extenseurs du Genou et de la kinésithérapie Conventionnelle Chez l'hémiplégique en Phase Chronique : étude Prospective, Pragmatique, en Intention de Traiter, randomisée, en Simple Insu, Multicentrique. |
| Estimated Enrollment: | 132 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | March 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Muscular Strengthening for paretic knee flexor and extensor
|
Other: Muscular Strengthening for paretic knee flexor and extensor
thrice a week during 6 weeks
|
|
2: No Intervention
conventional physiotherapy
|
Other: conventional physiotherapy
trice a week during 6 weeks
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Xavier D. de Boissezon, MD, phD | 663171027 ext 33 | deboissezon.x@chu-toulouse.fr |
| Contact: David Gasq | 675246931 ext 33 | phrc_renf_hemi@yahoo.fr |
| France | |
| Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032 | Recruiting |
| Toulouse, France, 31059 | |
| Contact: Xavier de Boissezon, MD, phD 0663171027 ext 33 deboissezon.x@chu-toulouse.fr | |
| Contact: David Gasq 0675246931 ext 33 phrc_renf_hemi@yahoo.fr | |
| Principal Investigator: Xavier de Boissezon, MD, PhD | |
| Sub-Investigator: Philippe Marque, MD, PhD | |
| Sub-Investigator: Evelyne Castel-Lacanal, MD | |
| Sub-Investigator: Sophie Gleizes-Cervera, MD | |
| Service de Médecine Physique et de Réadaptation, Hôpital Pllegrin, CHU de Bordeaux, | Not yet recruiting |
| Bordeaux, France, 33076 | |
| Contact: Patrick Dehail, MD, PhD 0556795546 ext 33 Patrick.dehail@chu-bordeaux.fr | |
| Principal Investigator: Patrick Dehail, MD, PhD | |
| Sub-Investigator: Mathieu de Seze, MD, PhD | |
| Sub-Investigator: François Muller, MD | |
| Sub-Investigator: Hervé Petit, MD | |
| Sub-Investigator: Laurent Wiart, MD | |
| Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges, | Not yet recruiting |
| Limoges, France, 87042 cedex | |
| Contact: Jean-Christophe Daviet, MD, PhD 0555056518 ext 33 jean-christophe.daviet@chu-limoges.fr | |
| Principal Investigator: Jean-Christophe Daviet, MD, PhD | |
| Sub-Investigator: Jean-Yves Salle, Md, PhD | |
| Sub-Investigator: Charlotte Verdié, MD | |
| Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié | Not yet recruiting |
| Albi, France, 81000 | |
| Contact: Eric Maupas, MD, PhD 0563457106 ext 33 emaupas@infomut.fr | |
| Principal Investigator: Eric Maupas, MD, PhD | |
| Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat | Not yet recruiting |
| Salies du Salat, France, 31260 | |
| Contact: Thomas Van den Bossche, MD 0561909344 ext 33 vendenbossche@chu-toulouse.fr | |
| Principal Investigator: Thomas Van den Bossche, MD | |
| Principal Investigator: | Xavier D de Boissezon | University Hospital, Toulouse |
More Information
| Responsible Party: | University Hospital, Toulouse ( Dr Xavier de Boissezon ) |
| Study ID Numbers: | 0702008, PHRC |
| Study First Received: | December 7, 2007 |
| Last Updated: | August 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00570570 History of Changes |
| Health Authority: | France: Ministry of Health |
|
stroke hemiplegia gait Strengthening Physiotherapy |
|
Hemiplegia Cerebral Infarction Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases |
Cerebrovascular Disorders Paralysis Signs and Symptoms Brain Ischemia Neurologic Manifestations Cardiovascular Diseases Brain Infarction |
