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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Toulouse
Sponsor:
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: November 8, 2013
Last verified: November 2013
  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: December 2013
Estimated Primary Completion Date: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: November 8, 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 July 23, 2014