Clinical trial NCT00570570: Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
Official title: Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Stroke
Keywords: stroke
hemiplegia
gait
Strengthening
Physiotherapy
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: University Hospital, Bordeaux
name: University Hospital, Limoges
First posted: 2007-12-11
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Gait comfortable speed
timeFrame: 3 months
Secondary outcomes:
measure: gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)
timeFrame: 3 months
Other outcomes:
Locations:
city: Albi
country: France
facility: Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié
city: Bordeaux
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,
city: Limoges
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,
city: Salies du Salat
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat
city: Toulouse
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032
Study officials:
affiliation: University Hospital, Toulouse
name: Xavier D de Boissezon
role: PRINCIPAL_INVESTIGATOR
References: