- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02785419
Action Selection and Arm Rehabilitation After Stroke
16 juli 2021 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
32
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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South Carolina
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Columbia, South Carolina, Förenta staterna, 29208
- University of South Carolina
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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 och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Action Research Arm Test
Tidsram: 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
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
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Upper Extremity Fugl-Meyer Motor Assessment
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
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 (Faktisk)
8 december 2015
Primärt slutförande (Faktisk)
1 december 2020
Avslutad studie (Faktisk)
1 december 2020
Studieregistreringsdatum
Först inskickad
9 maj 2016
Först inskickad som uppfyllde QC-kriterierna
24 maj 2016
Första postat (Uppskatta)
27 maj 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2021
Senast verifierad
1 juli 2021
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00032516
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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