Long-Term Effects Of An Early Individualised Retraining Programme On Walking Ability In Patients Following Hemiplegic Stroke

NCT ID: NCT01907451

Last Updated: 2013-07-25

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 14 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-09-30

Brief Summary

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

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

The control group

will receive support "traditional"10 hours per week: techniques called neuro-facilitators

No interventions assigned to this group

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).

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Casillas PHRC IR 2009

Identifier Type: -

Identifier Source: org_study_id