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

Study Description

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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

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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

Arms and Interventions

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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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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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
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