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

Primary Purpose

Hemiplegia, Stroke

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Muscular Strengthening for paretic knee flexor and extensor
conventional physiotherapy
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring stroke, hemiplegia, gait, Strengthening, Physiotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié
  • Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,
  • Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,
  • Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat
  • Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

group 1

group 2

Arm Description

Muscular Strengthening for paretic knee flexor and extensor

conventional physiotherapy

Outcomes

Primary Outcome Measures

Gait comfortable speed

Secondary Outcome Measures

gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)

Full Information

First Posted
December 7, 2007
Last Updated
August 19, 2015
Sponsor
University Hospital, Toulouse
Collaborators
University Hospital, Bordeaux, University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT00570570
Brief Title
Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
Acronym
RenforcHémi
Official Title
Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
University Hospital, Bordeaux, University Hospital, Limoges

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Stroke
Keywords
stroke, hemiplegia, gait, Strengthening, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Other
Arm Description
Muscular Strengthening for paretic knee flexor and extensor
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
conventional physiotherapy
Intervention Type
Procedure
Intervention Name(s)
Muscular Strengthening for paretic knee flexor and extensor
Intervention Description
thrice a week during 6 weeks
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Intervention Description
trice a week during 6 weeks
Primary Outcome Measure Information:
Title
Gait comfortable speed
Time Frame
3 months
Secondary Outcome Measure Information:
Title
gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier D de Boissezon
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié
City
Albi
ZIP/Postal Code
81000
Country
France
Facility Name
Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,
City
Limoges
ZIP/Postal Code
87042 cedex
Country
France
Facility Name
Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat
City
Salies du Salat
ZIP/Postal Code
31260
Country
France
Facility Name
Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032
City
Toulouse
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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

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