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

This study has been completed.
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: August 19, 2015
Last verified: August 2015
  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: Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients

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 ]

Enrollment: 91
Study Start Date: May 2008
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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   (Adult, Senior)
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

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

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT00570570     History of Changes
Other Study ID Numbers: 07 020 08  PHRC 
Study First Received: December 7, 2007
Last Updated: August 19, 2015
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on July 27, 2016