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Clinical Trial NCT06048419 for Cerebral Palsy, Hemiplegic Cerebral Palsy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Acceptability and Efficacy of GO MOVE 50 Exercise-Based
Clinical Trial NCT06048419 is an interventional study for Cerebral Palsy, Hemiplegic Cerebral Palsy that is recruiting. It started on 20 February 2024 with plans to enroll 50 participants. Led by Texas Scottish Rite Hospital for Children, it is expected to complete by 1 December 2026. The latest data from ClinicalTrials.gov was last updated on 10 March 2025.
Brief Summary
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...
Official Title
Acceptability and Efficacy of GO MOVE: A Mobile Health Technology for Youth With Unilateral Cerebral Palsy
Conditions
Cerebral PalsyHemiplegic Cerebral PalsyOther Study IDs
- STU-2023-0531
NCT ID Number
Start Date (Actual)
2024-02-20
Last Update Posted
2025-03-10
Completion Date (Estimated)
2026-12
Enrollment (Estimated)
50
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
home program
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalGo Move Home Program Goal driven home program | Home Program Home program for 6 weeks (1 hr and 15 minutes per week) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child
Minimum Age
3 Years
Eligible Sexes
All
- 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 ChildrenStudy Responsible Party
Angela Shierk, Principal Investigator, Clinical Scientist, Texas Scottish Rite Hospital for Children
Study Central Contact
Contact: Angela Shierk, PhD, 4694127172, [email protected]
Contact: Heather Roberts, PhD, 214-794-8117, [email protected]
1 Study Locations in 1 Countries
Texas
Scottish Rite for Children, Frisco, Texas, 75034, United States
Angela Shierk, PhD, Contact, 469-412-7172, [email protected]
Recruiting