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

Stroke Clinical Trial

— letswalk  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01907451
• Other study ID #: Casillas PHRC IR 2009
• Status: Terminated
• Phase: N/A
• First received: July 17, 2013
• Last updated: July 24, 2013
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: July 2013
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	participants will be followed for the duration of hospital stay, an expected average of 12 months	No
Primary	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.	participants will be followed for the duration of hospital stay, an expected average of 12 months	No