Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients (RenforcHémi)
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Toulouse
Sponsor:
University Hospital, Toulouse
Collaborators:
University Hospital, Bordeaux
University Hospital, Limoges
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00570570
First received: December 7, 2007
Last updated: January 22, 2013
Last verified: January 2013
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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 |
Procedure: Muscular Strengthening for paretic knee flexor and extensor Other: conventional physiotherapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Toulouse:
Primary Outcome Measures:
- Gait comfortable speed [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | May 2008 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Muscular Strengthening for paretic knee flexor and extensor
|
Procedure: Muscular Strengthening for paretic knee flexor and extensor
thrice a week during 6 weeks
|
|
Active Comparator: 2
conventional physiotherapy
|
Other: conventional physiotherapy
trice a week during 6 weeks
|
Detailed Description:
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 |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00570570
Contacts
| 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 |
Locations
| France | |
| 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 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 | |
| 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 | |
| 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 | |
Sponsors and Collaborators
University Hospital, Toulouse
University Hospital, Bordeaux
University Hospital, Limoges
Investigators
| Principal Investigator: | Xavier D de Boissezon | University Hospital, Toulouse |
More Information
No publications provided
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT00570570 History of Changes |
| Other Study ID Numbers: | 0702008, PHRC |
| Study First Received: | December 7, 2007 |
| Last Updated: | January 22, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by University Hospital, Toulouse:
|
stroke hemiplegia gait Strengthening Physiotherapy |
Additional relevant MeSH terms:
|
Hemiplegia Stroke Cerebral Infarction Paralysis Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on May 16, 2013