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

History of Changes

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:

Genetic and Rare Diseases Information Center resources: Hemiplegia

U.S. FDA Resources

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 September 26, 2016

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