- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Montpellier, Frankrike, 34000
- Service de Médecine Physique et de Réadaptation
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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,
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Placebo komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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upper limb motor function
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Flavia COROIAN, MD, UH Montpellier
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 8571
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