- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01554137
Interests of Strengthening Isokinetic Upper Extremity Hemiparetic Sequelae in Patients
Stroke (CVA) is the leading cause of death and the leading cause of disability in developed countries as in developing countries (WHO, 2000). In the aftermath of a stroke, patients keep a permanent disability in 75% of cases and only one quarter of them is able to resume work. The post stroke sequelae are sensory-motor and cognitive.
According to literature data, 75-83% of patients who survive a stroke learn to walk only 25 to 45% recover use of their upper limb in activities of daily living (Friedman, 1990).
The existence of a phase called "plateau" in motor recovery after stroke has been suggested (Colautti, 2001). This would occur beyond the 4 th month and would correspond to a phase where the rehabilitation techniques used in the subacute phase are deemed less effective. Recently, Page (2004) speculated that this plateau phase is rather the consequence of adaptation to the type of patient follow-up training and not that of a limit to the possibilities of recovery. In an observational study on the recovery of upper limb conducted over a period of 4 years, Broeks (2004) showed a possible recovery beyond 16 weeks post stroke. The results of studies on different techniques for rehabilitation of chronic stroke patients tend to confirm the hypothesis of page. Therefore, varying the training parameters (type, intensity, frequency) could improve the functional capabilities of these patients, even at a distance of stroke.
Strength training is part of the management of hemiparetic patients. The results of several studies show an improvement in muscle strength and functional ability to walk after a building program isokinetic lower limb (Sharp, 1997).
The objective of our project is to evaluate the effectiveness of a building program of isokinetic muscle on the paretic limb motor recovery in hemiparetic patients over 6 months of a stroke.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Montpellier, Francia, 34000
- Service de Médecine Physique et de Réadaptation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients with more than 6 months post stroke,
- Muscular control greater than or equal to 3 on the extensors and elbow flexors,
- Muscular control greater than or equal to 3 on the flexors and extensors of the wrist,
- Spasticity less than or equal to 3 on the muscle groups mentioned above, s
- Active abduction of the shoulder above 60 ° and painless
- Absence of cognitive impairment (MMS> 22 without any trouble phasic)
- No orthopedic limitations at the elbow and wrist,
Exclusion Criteria:
- Progressive neurological or systemic involvement,
- Orthopedic limitations at the elbow or wrist
- Cognitive,
- Hemineglect,
- Severe aphasia with impaired comprehension,
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: With isokinetic strength training
60 minutes isokinetic strength training on concentric mode
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The experimental group will follow a program of 18 sessions (3 sessions per week for 6 weeks) with a physiotherapy treatment (30 minutes) and occupational therapy (30 minutes), and a building session isokinetic concentric mode extensor and flexor muscles of the elbow extensors and wrist flexors.
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Comparatore placebo: without isokinetic strength training
passive motion 60 minutes
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The control group will follow a program of 18 sessions of physiotherapy and occupational therapy combined with 18 sessions of passive motion in flexion-elbow extension, wrist flexion-extension on the isokinetic device
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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upper limb motor function
Lasso di tempo: 6 weeks
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improving upper limb motor recovery at the end of the program is evaluated by the Fugl-Meyer test.This test evaluates motor impairment of the hemiplegic upper limb, balance, sensitivity, passive joint mobility and joint pain at mobilization.
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6 weeks
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Flavia COROIAN, MD, UH Montpellier
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 8571
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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