Acceptability and Efficacy of GO MOVE

Acceptability and Efficacy of GO MOVE: A Mobile Health Technology for Youth With Unilateral Cerebral Palsy

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Hemiplegic Cerebral Palsy
• Intervention / Treatment: Behavioral: Home Program

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Shierk, PhD; Phone Number: 1045 4694127172; Email: angela.shierk@tsrh.org
• Study Contact Backup: Name: Heather Roberts, PhD; Phone Number: 214-794-8117; Email: hroberts3@twu.edu

Study Locations

• United States
  • Texas
    • Frisco, Texas, United States, 75034
      • Recruiting
      • Scottish Rite for Children
      • Contact: Angela Shierk, PhD; Phone Number: 469-412-7172; Email: angela.shierk@tsrh.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Go Move Home Program; Goal driven home program	Behavioral: Home Program; Home program for 6 weeks (1 hr and 15 minutes per week)

What is the study measuring?

Primary 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)

Secondary Outcome Measures

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic information	Demographic in formation will be collected including: age in years and months, gender, etiology of cerebral palsy, qualitative description of previous exposure to therapy	within 2 weeks of start of intervention (pre-intervention)
Gross Motor Function Classification System (GMFCS)	The Gross Motor Function Classification Systems is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy with 1 being the lowest functioning and 5 being the highest	within 2 weeks of start of intervention (pre-intervention)
Manual Ability Classification Scale (MACS)	The Manual Ability Classification Scale describes how children with cerebral palsy use their hands during activities of daily living with 1 being the least functional and 5 being the most functional	within 2 weeks of start of intervention (pre-intervention)
Mobile App Rating Scale (MARS)	The Moblie App Rating Scale is an objective, multidimensional tool to assess the quality of mobile health apps using likert scaling with 1 being the lowest rating and 5 being the highest	within 2 weeks of end of intervention (post-intervention)
Feasibility and satisfaction with using the Go Move website	A likert scale from 1-5 on the satisfaction and ease of using the Go Move website and qualitative data collection with 1 being the lowest rating and 5 being the highest	within 2 weeks of end of intervention (post-intervention)

Collaborators and Investigators

• Sponsor: Texas Scottish Rite Hospital for Children
• Investigators: Principal Investigator: Angela Shierk, PhD, Scottish Rite for Children

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: home program
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: STU-2023-0531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No