Acceptability and Efficacy of GO MOVE

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048419
• Other study ID #: STU-2023-0531
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Texas Scottish Rite Hospital for Children
• Contact: Angela Shierk, PhD
• Phone: 4694127172
• Email: angela.shierk[@]tsrh.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy
• Hemiplegic Cerebral Palsy
• Paralysis

Intervention

Behavioral:
• Home Program
Home program for 6 weeks (1 hr and 15 minutes per week)

Locations

Country	Name	City	State
United States	Scottish Rite for Children	Frisco	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas Scottish Rite Hospital for Children

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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	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)
Secondary	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)