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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT01907451
First received: July 17, 2013
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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


Condition
Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire Dijon:

Primary Outcome Measures:
  • Neuromotor capacity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 months ] [ Designated as safety issue: No ]

    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.

  • functional capacity [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 12 months ] [ Designated as safety issue: No ]

    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.


Enrollment: 14
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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).

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT01907451     History of Changes
Other Study ID Numbers: Casillas PHRC IR 2009
Study First Received: July 17, 2013
Last Updated: July 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on August 20, 2014