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CompletedNCT00570570RenforcHémiUpdated Aug 20, 2015

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

An interventional study of Muscular Strengthening for paretic knee flexor and extensor and conventional physiotherapy in Hemiplegia and Stroke, sponsored by University Hospital, Toulouse. Completed at 5 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-20.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemiplegia
  • Stroke

Keywords

  • stroke
  • hemiplegia
  • gait
  • Strengthening
  • Physiotherapy
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 91 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
91 participants (actual)

Study arms

  • Other
    group 1

    Muscular Strengthening for paretic knee flexor and extensor

    Procedure: Muscular Strengthening for paretic knee flexor and extensor

  • Active comparator
    group 2

    conventional physiotherapy

    Other: conventional physiotherapy

Interventions

  • ProcedureMuscular Strengthening for paretic knee flexor and extensor

    thrice a week during 6 weeks

  • Otherconventional physiotherapy

    trice a week during 6 weeks

06

What researchers measure

Primary outcomes

  1. Gait comfortable speed

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 3 months

07

Study locations

5 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00570570
Lead sponsor
University Hospital, Toulouse
Collaborators
University Hospital, Bordeaux, University Hospital, Limoges
Responsible party
Sponsor
First posted
Dec 11, 2007
Start date
May 2008
Primary completion
Dec 2013
Completion
Dec 2013
Last update
Aug 20, 2015

Study contacts

Xavier D de Boissezon
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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