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- Klinische proef NCT07698522
Digital Technology-Informed Stroke Rehabilitation
The goal of this study is to determine the effects of lab and home-based technology guidance during movement training post-stroke. The study will compare movement training informed by lab-based technology to training delivered with technology at home. The main questions it aims to answer are:
- How well do lab and home-based technologies help individuals post-stroke improve their movement patterns?
- Is there a difference in improvement between the in-lab and at-home training groups?
- Which technologies lead to the most improvement?
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
The study is a randomized, controlled feasibility trial investigating rehabilitation to improve movement patterns after stroke. The study will recruit participants who have had a stroke that led to upper-extremity impairment. Individuals will be assigned to one of two digital technology-guided groups. One group will be guided through exercises in a home-based setting, the other will be lab-based.
Participants will engage in training sessions multiple days a week for up to 6 weeks, either in-lab or at home. Both groups will visit the lab weekly for movement assessments.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Samantha McNeill
- Telefoonnummer: (385) 215-9146
- E-mail: samantha.mcneill@utah.edu
Studie Locaties
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84112
- Werving
- Kennecott Mechanical Engineering Building
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Contact:
- Scott Uhlrich, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age between 30-85 years.
- Diagnosis of stroke.
- Stroke onset of at least six months prior to the time of participation.
- Fugl Meyer Upper Extremity between 30-50 (mild-moderate)
- Cognitive skills to consent and actively participate, as indicated by scores of ≥ 24 on the Mini- Mental Status Examination
- Able to visit lab up to 5x per week for 3 weeks
Exclusion Criteria:
- Presence of severe aphasia preventing the ability to follow 1-step directions at least 80% of the time.
- Excessive spasticity of the wrist, elbow, and shoulder, defined as a Modified Ashworth Score >2.
- Diagnosis of neurological disorders other than stroke.
- Orthopedic/musculoskeletal conditions (e.g., severe arthritis) affecting the upper extremity.
- Currently or planning to become pregnant.
- Participation in concurrent occupational therapy.
- Unilateral neglect, defined as failure of the Line Bisection Task
- Upper extremity pain >= 7/10 on Numeric Rating Scale
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: At-Home Training
Participants will train at-home.
|
Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently.
This guidance will be delivered using home-based technologies, such as a computer or tablet.
|
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Experimenteel: In-Lab Training
Participants will train in the lab.
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Participants will receive computer-generated guidance on how to perform different activities of daily living efficiently.
The guidance will be delivered using lab-based sensing and feedback technology.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Kinematic movement quality score
Tijdsspanne: From enrollment to the end of treatment at 3 weeks.
|
A score based on subject kinematics during a daily task (like reaching), comparing the subject's reaching kinematics to normative kinematics.
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From enrollment to the end of treatment at 3 weeks.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
FMA-UE Score
Tijdsspanne: From enrollment to the end of treatment at 3 weeks.
|
Upper Extremity Fugl-Meyer Score
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From enrollment to the end of treatment at 3 weeks.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Scott Uhlrich, PhD, University of Utah
Studie record data
Bestudeer belangrijke data
Studie start (Geschat)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- IRB_00203244
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- ANALYTIC_CODE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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