StrokeletswalkNCT01907451
Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke
An observational study of Stroke, run by Centre Hospitalier Universitaire Dijon.
Trial summary
This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Sep 2011
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients hospitalized in the Physical Medicine and Rehabilitation (PMR) units of Dijon and Besançon CHU, and the Functional Rehabilitation Centres of Divio (Dijon) and Bregille (Besançon)
Who may be able to join
- Patients benefiting from classical rehabilitation following cardiovascular accident (cerebral infarction or spontaneous intracerebral hematoma) according to current recommendations (conference de consensus sur l'orientation des patients atteints d'AVC des societes Françaises de Medecine Physique et Readaptation (MPR), d'Urgence Neuro-Vasculaire et de Geriatrie et Gerontologie), hospitalized in the Physical Medicine and Rehabilitation (PMR) units of Dijon and Besançon CHU, and the Functional Rehabilitation Centres of Divio (Dijon) and Bregille (Besançon)
- Age between 18 and 85 years.
- Etiological examination carried out according to current recommendations (CT scan and/or MRI, Holter ECG and Holter blood pressure, Doppler of the supra-aortic trunks, echocardiography).
- Patients referred to the PMR unit less than one month after the cerebral vascular accident.
- Clinical status considered stable from a cardiovascular and neurological point of view with a well-balanced medical treatment (anti-hypertensives, anti-coagulants or antiplatelets, oral antidiabetics if necessary)
- Patients able to understand the instructions and the interest of retraining.
- Patients who have provided written informed consent for the study.
Who cannot join
- Existence of disorders associated with hemiplegic motor impairment: disorders of memory and superior functions (MMSE < 24) and impaired ability to understand (BDAE <3), deep sensitivity disorders, severe unilateral neglect (bells test).
- Patients referred following meningeal hemorrhage or deep vein thrombosis
- Recurrent stroke, whatever the severity of the sequelae of the previous stroke.
- Existence of cerebellar involvement as a major aspect of the clinical picture
- Myocardial infarction or heart surgery within the preceding 6 months.
- Severe heart failure (NYHA >3 or left ventricular ejection fraction (LVEF) <40%).
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- Subjects presenting with complete non-stabilized arrhythmia
- Any metabolic, infectious, inflammatory, respiratory or cardiovascular disease that is not stabilized or constitutes a contra indication to retraining (chronic respiratory insufficiency (obstructive or restrictive), severe valve disease, obstructive heart disease, severe progressive heart rhythm or conduction disorders, intracavitary thrombus.
- Symptomatic peripheralartery disease (Leriche and Fontaine stage 3 or 4).
- Any other debilitating neurological disease (multiple sclerosis, Parkinson's disease).
- Participation in another biomedical research protocol during the retraining period (8 weeks minimum)
- Patients under guardianship or ward of court.
About this study
This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke.
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The control group | will receive support "traditional"10 hours per week: techniques called neuro-facilitators | |
| test group | enjoy the same support as control group at 7 hours week, coupled with a personalized retraining effort ergometer for 3 hours per week: after a 5 minute warm to 50% of Heart Rate Maximum (HRmax) of the initial test effort (TE), continuous work of 20 minutes at an intensity corresponding to 70% HRmax, followed by a recovery period of 5 min between active 40 and 50% of maximum heart rate (5 times per week). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromotor capacity
The walking speed of 10 meters.
- The level of disability by the scale of the Functional Independence Measure (FIM) - Functional walking ability, assessed clinically by Functional Ambulation Classification (FAC), as amended to Month 2 and Month 6.
- The ability to balance by static posturography: a collection of the path length not the center of the plantar pressure stabilogram.
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 months
functional capacity
The walking speed of 10 meters.
- The level of disability by the scale of the Functional Independence Measure (FIM) - Functional walking ability, assessed clinically by Functional Ambulation Classification (FAC), as amended to Month 2 and Month 6.
- The ability to balance by static posturography: a collection of the path length not the center of the plantar pressure stabilogram.
Measured: participants will be followed for the duration of hospital stay, an expected average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startMay 2010
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907451
- Sponsor's protocol ID
- Casillas PHRC IR 2009
- Acronym
- letswalk
- Status last verified
- Jul 2013
- First submitted
- 17 Jul 2013
- Last updated
- 25 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke
- ClinicalTrials.gov ID
- NCT01907451
- Acronym / sponsor ID
- letswalk / Casillas PHRC IR 2009
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Jul 2013 (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.
This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group | – | –will receive support "traditional"10 hours per week: techniques called neuro-facilitators |
| test group | – | –enjoy the same support as control group at 7 hours week, coupled with a personalized retraining effort ergometer for 3 hours per week: after a 5 minute warm to 50% of Heart Rate Maximum (HRmax) of the initial test effort (TE), continuous work of 20 minutes at an intensity corresponding to 70% HRmax, followed by a recovery period of 5 min between active 40 and 50% of maximum heart rate (5 times per week). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in the Physical Medicine and Rehabilitation (PMR) units of Dijon and Besançon CHU, and the Functional Rehabilitation Centres of Divio (Dijon) and Bregille (Besançon)
Key inclusion criteria (7 listed)
- Patients benefiting from classical rehabilitation following cardiovascular accident (cerebral infarction or spontaneous intracerebral hematoma) according to current recommendations (conference de consensus sur l'orientation des patients atteints d'AVC des societes Françaises de Medecine Physique et Readaptation (MPR), d'Urgence Neuro-Vasculaire et de Geriatrie et Gerontologie), hospitalized in the Physical Medicine and Rehabilitation (PMR) units of Dijon and Besançon CHU, and the Functional Rehabilitation Centres of Divio (Dijon) and Bregille (Besançon)
- Age between 18 and 85 years.
- Etiological examination carried out according to current recommendations (CT scan and/or MRI, Holter ECG and Holter blood pressure, Doppler of the supra-aortic trunks, echocardiography).
- Patients referred to the PMR unit less than one month after the cerebral vascular accident.
- Clinical status considered stable from a cardiovascular and neurological point of view with a well-balanced medical treatment (anti-hypertensives, anti-coagulants or antiplatelets, oral antidiabetics if necessary)
Key exclusion criteria (12 listed)
- Existence of disorders associated with hemiplegic motor impairment: disorders of memory and superior functions (MMSE < 24) and impaired ability to understand (BDAE <3), deep sensitivity disorders, severe unilateral neglect (bells test).
- Patients referred following meningeal hemorrhage or deep vein thrombosis
- Recurrent stroke, whatever the severity of the sequelae of the previous stroke.
- Existence of cerebellar involvement as a major aspect of the clinical picture
- Myocardial infarction or heart surgery within the preceding 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neuromotor capacity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 months
The walking speed of 10 meters. * The level of disability by the scale of the Functional Independence Measure (FIM) - Functional walking ability, assessed clinically by Functional Ambulation Classification (FAC), as amended to Month 2 and Month 6. * The ability to balance by static posturography: a collection of the path length not the center of the plantar pressure stabilogram.
functional capacity
Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 months
The walking speed of 10 meters. * The level of disability by the scale of the Functional Independence Measure (FIM) - Functional walking ability, assessed clinically by Functional Ambulation Classification (FAC), as amended to Month 2 and Month 6. * The ability to balance by static posturography: a collection of the path length not the center of the plantar pressure stabilogram.
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 25 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Centre Hospitalier Universitaire Dijon.
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 7 inclusion and 12 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 25 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
Neuromotor capacity (time frame: participants will be followed for the duration of hospital stay, an expected average of 12 months). The study lists 2 primary outcomes in all. 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 25 Jul 2013.