HemiplegiaNCT00284115
Efficacy of a Mechanical Gait Repetitive Training Technique in Hemiparetic Stroke Patients (AVC)
A study testing Gait trainer and Conventional rehabilitation in people with Hemiplegia and Stroke, run by Rennes University Hospital at 12 sites in France.
Trial summary
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemiplegia, Stroke
- What is being tested?
- Gait trainer and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 12 sitesFrance
- Study dates
- Mar 2006to May 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged 18 years or more
- Hemiplegia secondary to stroke
- Interval between stroke and study inclusion of 4 month or less
- First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke
- Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1)
- Being able to sit unsupported at the edge of the bed
- No severe impairment of cognition or communication
- Written informed consent
Who cannot join
- Orthopedic and/or rheumatological disease impairing mobility
- Other Neurological associated disease
- History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion
- Chronic pulmonary disease
- Intolerance to stand up
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
France12 sites
Rééducation et Réadaptation Fonctionnelle - Hôpital Intercommunal Robert Ballanger
Aulnay-sous-Bois, 93602
Centre du Docteur Bouffart-Vercelli
Cervera de la Marenda, 66290
Centre de Rééducation de Coubert
Coubert, 77170
Rééducation Fonctionnelle - Hôpital Raymond Poincaré
Garches, 92380
Centre l'espoir
Hellemmes-Lille, 59260
Centre Bretegnier
Héricourt, 70400
Département de Médecine Physique et Réadaptation - Hôpital Jean Rebeyrol
Limoges, 87000
Service de Médecine Physique et Réadaptation - Hôpital de l'Archet
Nice, 06202
Service de Médecine Physique et Réadaptation - Centre Hospitalier Le Grau du Roi
Nîmes, 30029
Service de Rééducation Neuro-orthopédique - Hôpital Rothschild
Paris, 75012
Service de Médecine Physique et Réadaptation - Hôpital Pontchaillou
Rennes, 35033
Centre de l'Arche
Saint-Saturnin, 72650
About this study
Official title: Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.
Read the detailed description
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.
The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.
- Conditions
- Hemiplegia, Stroke
- Being tested
- Gait trainer, Conventional rehabilitation
- Keywords
- Gait trainer, Hemiplegia, Rehabilitation, Stroke
- Medical subject headings
- Hemiplegia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait trainerDevice
Mechanical gait repetitive training
Conventional rehabilitationDevice
Physiotherapeutic conventional rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Mechanical gait repetitive training | Experimental | Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement Receives: Device: Gait trainer |
| Conventional rehabilitation program | Active comparator | Physiotherapeutic conventional rehabilitation program Receives: Device: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program
Measured: after 4 weeks
Secondary outcomes (7)
Functional ambulatory category
Measured: Days 0, 15, 28 and 90.
Walking endurance (6 minute walk)
distance covered in a 6 minutes confortable walk
Measured: days 15, 28 and 90.
Time to self sufficient gait recovery
Measured: Since inclusion Time
Spasticity (modified Ashworth score)
Measured: Days 0, 15, 28 and 90
Motricity index
Measured: Days 0, 15, 28 and 90
Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)
Measured: Days 0, 15, 28 and 90
Economic evaluation (healthcare requirements, rehabilitation unit length of stay)
Measured: At the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionMay 2011
- Study completionMay 2011
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 Rennes University HospitalThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Régine Brissot, MD, Principal investigator, Rennes University HospitalBruno Laviolle, MD, Study chair, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284115
- Sponsor's protocol ID
- AFSSAPS 2005/10/006
- Other IDs
- PHRC/04-02
- Status last verified
- Jul 2012
- First submitted
- 30 Jan 2006
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients
- ClinicalTrials.gov ID
- NCT00284115
- Acronym / sponsor ID
- AFSSAPS 2005/10/006
- Conditions
- Hemiplegia, Stroke
- Keywords
- Gait trainer, Hemiplegia, Rehabilitation, Stroke
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Mar 2006
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 31 Jan 2006 (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.
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.
Detailed description
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.
The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical gait repetitive training | Experimental | Device: Gait trainerBody weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement |
| Conventional rehabilitation program | Active comparator | Device: Conventional rehabilitationPhysiotherapeutic conventional rehabilitation program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men or women aged 18 years or more
- Hemiplegia secondary to stroke
- Interval between stroke and study inclusion of 4 month or less
- First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke
- Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1)
Key exclusion criteria (5 listed)
- Orthopedic and/or rheumatological disease impairing mobility
- Other Neurological associated disease
- History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion
- Chronic pulmonary disease
- Intolerance to stand up
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 |
|---|---|---|
| Gait trainerMechanical gait repetitive training | Device | Mechanical gait repetitive training |
| Conventional rehabilitationPhysiotherapeutic conventional rehabilitation | Device | Conventional rehabilitation program |
Primary outcome
Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program
Time frame: after 4 weeks
7 secondary outcomes
Functional ambulatory category
Time frame: Days 0, 15, 28 and 90.
Walking endurance (6 minute walk)
Time frame: days 15, 28 and 90.
Time to self sufficient gait recovery
Time frame: Since inclusion Time
Spasticity (modified Ashworth score)
Time frame: Days 0, 15, 28 and 90
Motricity index
Time frame: Days 0, 15, 28 and 90
Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)
Time frame: Days 0, 15, 28 and 90
Economic evaluation (healthcare requirements, rehabilitation unit length of stay)
Time frame: At the end of the study
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2012.
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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.
Régine Brissot, MD principal investigator
Rennes University Hospital
Bruno Laviolle, MD study chair
Rennes University Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait trainer and Conventional rehabilitation in people with Hemiplegia and Stroke, run by Rennes University Hospital at 12 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 8 inclusion and 5 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: stopped early, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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 was stopped early. Results are not available in the source record.
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?
Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program (time frame: after 4 weeks). 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 4 Jul 2012.