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TerminatedNCT01907451letswalkUpdated Jul 25, 2013

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

An observational study in Stroke, sponsored by Centre Hospitalier Universitaire Dijon. Terminated. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-07-25.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
14
Ages
18 Years to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Stroke

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03

In context

Stroke

7,441 studies on the registry are indexed under Stroke; 2,012 are open to participants now.

This study's enrollment of 14 is below the median of 160 across 1,729 observational studies indexed under Stroke.

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Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 499 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
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)

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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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and 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).

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 months

  2. 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.

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 12 months

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01907451
Responsible party
Sponsor
First posted
Jul 25, 2013
Start date
May 2010
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jul 25, 2013
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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