- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02785419
Action Selection and Arm Rehabilitation After Stroke
16. juli 2021 opdateret af: Jill Stewart, PT, PhD, University of South Carolina
Targeted Engagement of the Motor Action Selection Network During Arm Rehabilitation After Stroke
After stroke, individuals often have persistent difficulty using the arm and hand in everyday functional tasks that reduces quality of life.
Currently available rehabilitation techniques are not adequate and new protocols are needed that are based on an understanding of how brain regions work together to produce skilled movement.
This research project aims to improve our understanding of how the brain controls movement after stroke and determine whether a period of motor practice that targets specific brain regions through the addition of action selection demands leads to improved arm function.
We hypothesize that arm motor function and the ability to efficiently activate the action selection motor circuit during movement will improve after training.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Rehabilitation of arm impairment after stroke includes the repetitive practice of functional tasks.
In healthy adults, planning plays a vital role in the control of skilled movement, however, the behavioral and neural correlates of planning have largely been unexplored in individuals recovering from stroke.
Action selection is an important motor planning process that engages dorsal premotor cortex (PMd) in controls.
While PMd activation is a commonly reported neural correlate of motor recovery after stroke, the role of PMd in action selection and motor training are not known.
Therefore, the purpose of this study is to determine the effect of training that includes action selection demands on the behavioral and neural correlates of movement after stroke.
Thirty-eight individuals in the chronic phase of stroke will be recruited.
After completion of clinical measures of impairment and function, all participants with stroke will complete a motor action selection task and functional MRI followed by arm training.
Arm training will consist of three weeks (15 sessions) of arm motor training (1.5 hours per session) that includes action selection demands on movement.
Follow-up clinical testing will occur at the end of treatment and three weeks later.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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South Carolina
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Columbia, South Carolina, Forenede Stater, 29208
- University of South Carolina
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- At least 18 years old
- Had stroke at least 6 months ago
- Right-hand dominant prior to stroke
- Some continued arm and hand weakness
- Some ability to move the arm and hand that is weaker from the stroke
Exclusion Criteria:
- Acute medical issues that would interfere with participation
- Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
- Cannot undergo MRI scanning
- Severe apraxia or hemispatial neglect
- Pain in the arm that interferes with movement
- Difficulty maintaining attention or following directions
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Arm Training with Action Selection
Task-oriented, functional arm training with the addition of action selection cues to practice.
All participants receive the same arm training intervention.
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Treatment occurs in 1.5 hour sessions, 5 times a week for 3 weeks.
In each treatment session, you will practice functional tasks with your weaker arm and hand.
Additionally, you will be given cues on a computer screen that dictate your movement response (action selection).
Practice will be scaled to match your current level of function and progressed over time as able.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Action Research Arm Test
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Behavioral assessment of arm function.
Scores range from 0 to 57 with a higher score equating to better function.
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Change from baseline to end of treatment (3 weeks)
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Brain activation during functional MRI
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Brain activation during movement will be captured with functional MRI.
Analyses will investigate changes in magnitude of activation.
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Change from baseline to end of treatment (3 weeks)
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Brain connectivity during functional MRI
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Brain activation during movement will be captured with functional MRI.
Analyses will investigate changes in connectivity between brain regions.
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Change from baseline to end of treatment (3 weeks)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Upper Extremity Fugl-Meyer Motor Assessment
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Stroke Impact Scale Hand Domain
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Box & Blocks Test
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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9-Hole Peg Test
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Grip Strength
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Confidence in Arm and Hand Movements Questionnaire
Tidsramme: Change from baseline to end of treatment (3 weeks)
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Change from baseline to end of treatment (3 weeks)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
8. december 2015
Primær færdiggørelse (Faktiske)
1. december 2020
Studieafslutning (Faktiske)
1. december 2020
Datoer for studieregistrering
Først indsendt
9. maj 2016
Først indsendt, der opfyldte QC-kriterier
24. maj 2016
Først opslået (Skøn)
27. maj 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
16. juli 2021
Sidst verificeret
1. juli 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00032516
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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