HemiplegiaRenforcHémiNCT00570570
Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
A study testing Muscular Strengthening for paretic knee flexor and extensor and conventional physiotherapy in people with Hemiplegia and Stroke, run by University Hospital, Toulouse at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Muscular Strengthening for paretic knee flexor and extensor and conventional physiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 5 sitesFrance
- Study dates
- May 2008to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Centre Mutualiste de Rééducation Fonctionnelle, rue Angély Cavlié
Albi, 81000
Service de Médecine Physique et de Réadaptation, Hôpital Pellegrin, CHU de Bordeaux,
Bordeaux, 33076
Service de Médecine Physique et de Réadaptation, Hôpital Jean Rebeyrol, CHU de Limoges,
Limoges, 87042 cedex
Service de Médecine Physique et de Réadaptation, Hôpital de Salies du Salat
Salies-du-Salat, 31260
Service de Médecine Physique et de Réadaptation, Hôpital Rangueil, CHU de Toulouse, TSA 50032
Toulouse, 31059
About this study
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.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Muscular Strengthening for paretic knee flexor and extensor, conventional physiotherapy
- Keywords
- stroke, hemiplegia, gait, Strengthening, Physiotherapy
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscular Strengthening for paretic knee flexor and extensorProcedure or surgery
thrice a week during 6 weeks
conventional physiotherapyOther
trice a week during 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Other | Muscular Strengthening for paretic knee flexor and extensor Receives: Procedure: Muscular Strengthening for paretic knee flexor and extensor |
| group 2 | Active comparator | conventional physiotherapy Receives: Other: conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait comfortable speed
Measured: 3 months
Secondary outcomes (1)
gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startMay 2008
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Limoges
- Responsible party
- Sponsor
- Investigators
- Xavier D de Boissezon, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570570
- Sponsor's protocol ID
- 07 020 08
- Other IDs
- PHRC
- Acronym
- RenforcHémi
- Status last verified
- Aug 2015
- First submitted
- 7 Dec 2007
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscular Strengthening for Paretic Knee Flexor and Extensor by Conventional Physiotherapy on Chronic Hemiplegic Stroke Patients
- ClinicalTrials.gov ID
- NCT00570570
- Acronym / sponsor ID
- RenforcHémi / 07 020 08
- Conditions
- Hemiplegia, Stroke
- Keywords
- stroke, hemiplegia, gait, Strengthening, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Limoges
- Study start
- May 2008
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Other | Procedure: Muscular Strengthening for paretic knee flexor and extensorMuscular Strengthening for paretic knee flexor and extensor |
| group 2 | Active comparator | Other: conventional physiotherapyconventional physiotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscular Strengthening for paretic knee flexor and extensorthrice a week during 6 weeks | Procedure or surgery | group 1 |
| conventional physiotherapytrice a week during 6 weeks | Other | group 2 |
Primary outcome
Gait comfortable speed
Time frame: 3 months
1 secondary outcome
gait analysis (gait maximal speed, kymographic and dynamometric analysis, quality of gait parameter) FIM MOS-SF36 Spasticity (Tardieu Scale)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier D de Boissezon principal investigator
University Hospital, Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscular Strengthening for paretic knee flexor and extensor and conventional physiotherapy in people with Hemiplegia and Stroke, run by University Hospital, Toulouse at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait comfortable speed (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2015.