Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
RenforcHémi
2 other identifiers
interventional
91
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2008
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2007
CompletedFirst Posted
Study publicly available on registry
December 11, 2007
CompletedStudy Start
First participant enrolled
May 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedAugust 20, 2015
August 1, 2015
5.6 years
December 7, 2007
August 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Gait comfortable speed
3 months
Secondary Outcomes (1)
gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)
3 months
Study Arms (2)
group 1
OTHERMuscular Strengthening for paretic knee flexor and extensor
group 2
ACTIVE COMPARATORconventional physiotherapy
Interventions
thrice a week during 6 weeks
Eligibility Criteria
You may qualify if:
- Hemipegia due to ischaemic or hemorrhagic stroke more than 6 months ago
- st 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Toulouselead
- University Hospital, Bordeauxcollaborator
- University Hospital, Limogescollaborator
Study Sites (5)
Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié
Albi, 81000, France
Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,
Bordeaux, 33076, France
Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,
Limoges, 87042 cedex, France
Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat
Salies-du-Salat, 31260, France
Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032
Toulouse, 31059, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xavier D de Boissezon
University Hospital, Toulouse
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 7, 2007
First Posted
December 11, 2007
Study Start
May 1, 2008
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
August 20, 2015
Record last verified: 2015-08