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

24 juli 2013 uppdaterad av: Centre Hospitalier Universitaire Dijon
This project aims to study the effects early individualised retraining programme on walking ability in patients following hemiplegic stroke.

Studieöversikt

Status

Avslutad

Betingelser

Studietyp

Observationell

Inskrivning (Faktisk)

14

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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)

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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).

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Neuromotor capacity
Tidsram: participants will be followed for the duration of hospital stay, an expected average of 12 months

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
functional capacity
Tidsram: participants will be followed for the duration of hospital stay, an expected average of 12 months

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2010

Primärt slutförande (Faktisk)

1 september 2011

Avslutad studie (Faktisk)

1 september 2011

Studieregistreringsdatum

Först inskickad

17 juli 2013

Först inskickad som uppfyllde QC-kriterierna

24 juli 2013

Första postat (Uppskatta)

25 juli 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 juli 2013

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 juli 2013

Senast verifierad

1 juli 2013

Mer information

Termer relaterade till denna studie

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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