Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke | NCT01907451 | Trialant
TerminatedObservationalUpdated Jul 25, 2013
Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke
ClinicalTrials.gov ID
NCT01907451
Lead Sponsor
Centre Hospitalier Universitaire DijonOTHER
Overall Status
Terminated
Study Type
Observational
Enrollment
14Actual
Last Update Posted
Jul 25, 2013Estimated
Start Date
May 2010
Primary Completion Date
Sep 2011Actual
Completion Date
Sep 2011Actual
Brief Summary
This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke.
Stroke
No interventions
There are no interventions for this study.
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)