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

Stroke Clinical Trial

— RenforcHémi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00570570
• Other study ID #: 07 020 08
• Secondary ID: PHRC
• Status: Completed
• Phase: N/A
• First received: December 7, 2007
• Last updated: August 19, 2015
• Start date: May 2008
• Est. completion date: December 2013

Study information

• Verified date: August 2015
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Procedure:
• Muscular Strengthening for paretic knee flexor and extensor
thrice a week during 6 weeks

Other:
• conventional physiotherapy
trice a week during 6 weeks

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Toulouse	University Hospital, Bordeaux, University Hospital, Limoges

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gait comfortable speed		3 months	No
Secondary	gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)		3 months	No