Clinical trial NCT01907451: Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2013-07-25
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

Brief summary: This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke.


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)
* Patients under guardianship or ward of court.

Primary outcomes:
measure: Neuromotor capacity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 months
measure: functional capacity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: