ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00570570
Recruitment Status : Completed
First Posted : December 11, 2007
Last Update Posted : August 20, 2015
Sponsor:
Collaborators:
University Hospital, Bordeaux
University Hospital, Limoges
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Hemiplegia Stroke Procedure: Muscular Strengthening for paretic knee flexor and extensor Other: conventional physiotherapy Not Applicable

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
Study Start Date : May 2008
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
group 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: group 2
conventional physiotherapy
 Other: conventional physiotherapy
trice a week during 6 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Gait comfortable speed [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale) [ Time Frame: 3 months ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00570570


Locations
France
Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié
Albi, France, 81000
Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,
Bordeaux, France, 33076
Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,
Limoges, France, 87042 cedex
Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat
Salies du Salat, France, 31260
Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032
Toulouse, France, 31059
Sponsors and Collaborators
University Hospital, Toulouse
University Hospital, Bordeaux
University Hospital, Limoges
Investigators
Principal Investigator: Xavier D de Boissezon University Hospital, Toulouse
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00570570     History of Changes
Other Study ID Numbers: 07 020 08
PHRC ( Other Grant/Funding Number: 07 020 08 )
First Posted: December 11, 2007    Key Record Dates
Last Update Posted: August 20, 2015
Last Verified: August 2015

Keywords provided by University Hospital, Toulouse:
stroke
hemiplegia
gait
Strengthening
Physiotherapy

Additional relevant MeSH terms:
Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms