- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01907451
Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke (letswalk)
July 24, 2013 updated by: Centre Hospitalier Universitaire Dijon
This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
14
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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)
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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%).
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
participants will be followed for the duration of hospital stay, an expected average of 12 months
|
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.
|
participants will be followed for the duration of hospital stay, an expected average of 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
July 24, 2013
First Posted (Estimate)
July 25, 2013
Study Record Updates
Last Update Posted (Estimate)
July 25, 2013
Last Update Submitted That Met QC Criteria
July 24, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Casillas PHRC IR 2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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