Clinical trial NCT06048419: Acceptability and Efficacy of GO MOVE
Official title: Acceptability and Efficacy of GO MOVE: A Mobile Health Technology for Youth With Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Hemiplegic Cerebral Palsy
Keywords: home program
Lead sponsor: Texas Scottish Rite Hospital for Children
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective cohort
Primary purpose: TREATMENT

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 goal attainment for youth with unilateral cerebral palsy?

Participants will set up and participate in a goal-driven home program using the Go Move mobile website. Participants will spend 1 hour and 15 minutes per week for 6 weeks working on their home program and will complete pre-intervention and post-intervention assessments.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Secondary outcomes:
measure: Goal Attainment Scale (GAS) Light
timeFrame: within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
measure: Assisting Hand Assessment (AHA) (optional)
timeFrame: within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Other outcomes:
measure: Demographic information
timeFrame: within 2 weeks of start of intervention (pre-intervention)
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: within 2 weeks of start of intervention (pre-intervention)
measure: Manual Ability Classification Scale (MACS)
timeFrame: within 2 weeks of start of intervention (pre-intervention)
measure: Mobile App Rating Scale (MARS)
timeFrame: within 2 weeks of end of intervention (post-intervention)
measure: Feasibility and satisfaction with using the Go Move website
timeFrame: within 2 weeks of end of intervention (post-intervention)
Locations:
city: Frisco
country: United States
facility: Scottish Rite for Children
state: Texas
Study officials:
affiliation: Scottish Rite for Children
name: Angela Shierk, PhD
role: PRINCIPAL_INVESTIGATOR
References: