- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03025776
One vs. Two Hand Use After Stroke: Role of Task Requirements (FSIFall2016)
25. januar 2018 opdateret af: Maureen Whitford, Cleveland State University
To further develop interventions, the investigators need a better understanding of which task requirements (i.e.
size or weight of object, location in workspace, etc.) drive a person after stroke to use 2 hands (as opposed to 1), and how the severity of their injury impacts this relationship and compare this to reaching in age-matched healthy controls subjects.
A better understanding of this relationship will promote more informed development of rehabilitative interventions.
This study proposes to explore in people after stroke and healthy controls: i.) how specific functional tasks requirements relate to 1 vs. 2 handed use, and ii.) how stroke severity impacts this arm use.
We are proposing to study 15 individuals more than 6 months after stroke in the CSU Motor Behavior Lab for a two x 3 hour session of task-related reaching in sitting and 33 age matched (double sample size) healthy controls.
The investigators will systematically vary task requirements (i.e.
object size or weight, location in workspace, etc.), and record use of 1 versus 2 hands using videotaping as well as recording of quality of arm movement (kinematics) and muscle activity (EMG) in both arms.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
48
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Cleveland, Ohio, Forenede Stater
- Cleveland State University
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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
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
adults > 18 years old chronic post-stroke with upper extremity paresis yet able to complete a reach-to-grasp task independently with their paretic arm healthy controls > 18 years old (as per above)
Beskrivelse
Inclusion Criteria:
subjects post-stroke
- passive flexibility (i.e. passive range of motion) in both arms such that the elbows can be straightened within 15 degrees of normal and shoulders be flexed (lifted up) at least 90 degrees and the hand needs to be able to open at least 75% of the way
- Actively (of each subject's own accord/ability) they must be able to, without assist in sitting and standing: straighten each elbow within 15 degrees of full range of motion, lift each arm up at at least 60 degrees from at the side, open each hand from a gross grasp volitionally.
- able to lift a glass jar using 1 or 2 hands in sitting and standing 10" above the table top.
- able to come to CSU for two x 3 hour visits with or without assistance of their caregiver/significant other
- No arm/hand injury within the last 3 months. * Individuals with common visual deficits post-stroke (1 side partial visual field cut aka homonymous hemianopsia) will be included.
Healthy controls:
-age matched (double sample size); no known injury to arms within last 3 months, able to carry out experimental task, no neurologic diagnoses/perceptual or sensory deficits affecting arm movement
Exclusion Criteria:
- Individuals who have any additional/other neurologic condition (i.e. Parkinsons Disease, multiple sclerosis, spinal cord injury)
- severe perceptual neglect (tested using clock drawing test ).
- Any individual who cannot answer phone screen questions competently and/or follow simple 2 step commands during the in-person screen
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
stroke
individuals chronic (> 6 months) post-stroke
|
sitting reaching under various task conditions (size, speed, location)
sitting reaching under various task conditions (size, speed, location), told how many & which hand to use, kinematic data collected
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|
age matched health controls
age matched (double sample size anticipated) healthy controls
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sitting reaching under various task conditions (size, speed, location)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Hand Use (qualitative analysis of how many hands, which hand used) via video
Tidsramme: within 1st day session only (assessed w/i 2-3 hour session only)
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within 1st day session only (assessed w/i 2-3 hour session only)
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upper extremity kinematics (peak velocity, index of curvature, total movement time)
Tidsramme: within 2nd day session only (assessed w/i 2-3 hour session only)
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measured on Day 2 session using electromagnetic sensors
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within 2nd day session only (assessed w/i 2-3 hour session only)
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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
1. september 2016
Primær færdiggørelse (Faktiske)
1. december 2017
Studieafslutning (Faktiske)
1. december 2017
Datoer for studieregistrering
Først indsendt
14. december 2016
Først indsendt, der opfyldte QC-kriterier
17. januar 2017
Først opslået (Skøn)
20. januar 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-FY2016-332
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 .
Kliniske forsøg med Reaching
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