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De klinische studie NCT06048419 voor Cerebrale parese, Hemiplegische cerebrale parese is rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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Kaartweergave
Acceptability and Efficacy of GO MOVE 50 Lichaamsbeweging
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De klinische studie NCT06048419 is een interventioneel studie bij Cerebrale parese, Hemiplegische cerebrale parese met de status rekruterend. Het doel is om 50 deelnemers te includeren vanaf 20 februari 2024. De studie wordt geleid door Texas Scottish Rite Hospital for Children en de voltooiing is gepland op 1 december 2026. Laatste update op ClinicalTrials.gov: 10 maart 2025.
Beknopte samenvatting
The goal of this clinical trial is to learn about the acceptability and efficacy of Go Move, a mobile website developed to assist youth with unilateral cerebral palsy and their caregivers with setting goals and selecting exercises and activities to meet the goals. The main question\[s\] it aims to answer are:
- Is Go Move accepted by youth with unilateral cerebral palsy and their caregivers?
- Does Go Move support g...
Officiële titel
Acceptability and Efficacy of GO MOVE: A Mobile Health Technology for Youth With Unilateral Cerebral Palsy
Aandoeningen
Cerebrale pareseHemiplegische cerebrale pareseAndere studie-ID's
- STU-2023-0531
NCT-ID
Startdatum (Werkelijk)
2024-02-20
Laatste update geplaatst
2025-03-10
Verwachte einddatum
2026-12
Inschrijving (Geschat)
50
Studietype
Interventioneel
FASE
N.v.t.
Status
Rekruterend
Trefwoorden
home program
Primaire doel
Behandeling
Toewijzing
N.v.t.
Interventiemodel
Enkele groep
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelGo Move Home Program Goal driven home program | Home Program Home program for 6 weeks (1 hr and 15 minutes per week) |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Canadian Occupational Performance Measure (COPM) | The Canadian Occupational Performance Measure is a criterion referenced, individualized, client-centered outcome measure designed for use by occupational therapists to detect change in a client's self-perception of occupational performance over time on a scale of 1-10 (1 being the lowest) | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Goal Attainment Scale (GAS) Light | The Goal Attainment Scale is an individualized, functional outcome measure involving goal selection and scaling. The scale ranges from -2 to +2 with -2 representing a decline in function, -1 no change, 0 expected outcome, +1 a little more, +2 a lot more. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Assisting Hand Assessment (AHA) (optional) | The Assisting Hand Assessment is a criterion referenced, valid and reliable 22-item measure that assesses the assisting or affected hand in carrying out bimanual activities for children with cerebral palsy or obstetric brachial plexus palsy measured by AHA units on a scale of 0-100 with 0 being the lowest level of function. | within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention) |
Deelname-assistent
Geschiktheidscriteria
Leeftijd van deelnemers
Kind
Minimumleeftijd
3 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Inclusion criteria for participants to enroll in the study include a diagnosis of unilateral CP or a non-progressive brain lesion, injury, or trauma of the developing brain that presents with a unilateral upper limb motor impairment. GMFCS levels 1 or 2. MACS levels 1-3. Age 3-17 years old, ability to follow directions, ability to complete the assessment protocol, and the ability to access the GO MOVE webpage on a personal device. All ethnic/racial groups will be eligible to participate. The ability to participate in everyday activities without restriction from a physician throughout the duration of their participation in the study (does not have restrictions/contraindications following a medical procedure).
- The study will exclude any patients with uncontrolled epilepsy or significant visual impairment. The study will exclude any patient with severe behavioral problems or the inability to complete the assessment protocol or home program.
Texas Scottish Rite Hospital for ChildrenVerantwoordelijke instantie
Angela Shierk, Hoofdonderzoeker, Clinical Scientist, Texas Scottish Rite Hospital for Children
Centraal Contactpersoon
Contact: Angela Shierk, PhD, 4694127172, [email protected]
Contact: Heather Roberts, PhD, 214-794-8117, [email protected]
1 Studielocaties in 1 landen
Texas
Scottish Rite for Children, Frisco, Texas, 75034, United States
Angela Shierk, PhD, Contact, 469-412-7172, [email protected]
Rekruterend