| December 7, 2007 |
| August 21, 2009 |
| May 2008 |
| February 2010 (final data collection date for primary outcome measure) |
| Gait comfortable speed [ Time Frame: 3 months ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00570570 on ClinicalTrials.gov Archive Site |
| 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 ] |
| Same as current |
| |
| Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients |
| Comparaison de l'efficacité du Renforcement Des Muscles fléchisseurs et Extenseurs du Genou et de la kinésithérapie Conventionnelle Chez l'hémiplégique en Phase Chronique : étude Prospective, Pragmatique, en Intention de Traiter, randomisée, en Simple Insu, Multicentrique. |
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. |
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. |
| |
| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Single Group Assignment, Safety/Efficacy Study |
|
|
- Other: Muscular Strengthening for paretic knee flexor and extensor
- Other: conventional physiotherapy
|
- Other: Muscular Strengthening for paretic knee flexor and extensor
- No Intervention: conventional physiotherapy
|
| |
| |
| Recruiting |
| 132 |
| March 2010 |
| February 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years to 80 Years |
| No |
|
|
| France |
| |
| NCT00570570 |
| Dr Xavier de Boissezon, University Hospital, Toulouse |
| 0702008, PHRC |
| University Hospital, Toulouse |
- University Hospital, Bordeaux
- University Hospital, Limoges
- Rehabilitation center Albi
- Local Hospital Salies du Salat
|
| Principal Investigator: |
Xavier D de Boissezon |
University Hospital, Toulouse |
|
|
| University Hospital, Toulouse |
| August 2009 |
