- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00681434
Bilateral Training Versus Unilateral Training in Stroke
Bilateral Training for Upper Extremity Hemiparesis in Stroke
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Upper extremity hemiparesis is the most common post-stroke disability. Longitudinal studies have indicated that 30 to 66 percent of stroke survivors do not have full arm function six months post-stroke. Bilateral arm training has been investigated as a potential rehabilitation intervention for individuals not eligible for constraint induced movement therapy.
This training study included 24 hours of treatment over eight weeks. The protocol consisted of reaching activities with rhythmic auditory cueing emphasizing the proximal arm. Subjects assigned to the bilateral group performed bilateral symmetrical activities while subjects in the unilateral group performed the same activity with the affected arm only. The Motor Assessment Scale-Upper Limb Item and the Motor Status Scale are used as primary outcome measures. The Reaching Performance Scale and strength measures are secondary outcome measures. Assessments are administered pre-/ and post-training by a blind rater.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- cortical or subcortical stroke
- chronic condition (at least six months prior)
- ability to follow 2-step commands
- ability to give consent
Exclusion Criteria:
- lesion in brain stem or cerebellum
- visual field cut
- neglect
- uncontrolled hypertension
- angina
- COPD
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 1
bilateral training
|
Bilateral symmetrical upper extremity training for proximal control for three hours per week for eight weeks.
|
Aktiv komparator: 2
Unilateral training
|
Unilateral upper extremity training for proximal extremity for three hours a week for eight weeks.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Motor Assessment Scale
Tidsramme: pre and post (week one and week 8)
|
pre and post (week one and week 8)
|
Motor Status Scale
Tidsramme: pre and post, Week 0 and Week eight
|
pre and post, Week 0 and Week eight
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Reaching Performance Scale
Tidsramme: pre and post training (Week 0 and week 8)
|
pre and post training (Week 0 and week 8)
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Mary E Stoykov, PhD, University of Illinois at Chicago Department of Kinesiology and Nutrition
- Studiestol: Daniel M Corcos, PhD, University of Illinois at Chicago Department of Kinesiology and Nutrition
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2006-0234
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Kliniske forsøg med bilateral upper extremity training
-
University of FloridaNational Institute of General Medical Sciences (NIGMS)Afsluttet