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NCT Number: NCT06048419

Acceptability and Efficacy of GO MOVE

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Hemiplegic Cerebral Palsy Nervous System Diseases

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scottish Rite for Children

Frisco, Texas, 75034, United States

Location status: Recruiting

Location contact

Angela Shierk, PhD

CONTACT

[email protected]

469-412-7172

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Home Program

Behavioral

Home program for 6 weeks (1 hr and 15 minutes per week)

Primary outcomes

  1. Canadian Occupational Performance Measure (COPM)

    Time frame: within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)

    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)

Secondary outcomes

  1. Goal Attainment Scale (GAS) Light

    Time frame: within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)

    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.

  2. Assisting Hand Assessment (AHA) (optional)

    Time frame: within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)

    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.

Other outcomes

  1. Demographic information

    Time frame: within 2 weeks of start of intervention (pre-intervention)

    Demographic in formation will be collected including: age in years and months, gender, etiology of cerebral palsy, qualitative description of previous exposure to therapy

  2. Gross Motor Function Classification System (GMFCS)

    Time frame: within 2 weeks of start of intervention (pre-intervention)

    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

  3. Manual Ability Classification Scale (MACS)

    Time frame: within 2 weeks of start of intervention (pre-intervention)

    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

  4. Mobile App Rating Scale (MARS)

    Time frame: within 2 weeks of end of intervention (post-intervention)

    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

  5. Feasibility and satisfaction with using the Go Move website

    Time frame: within 2 weeks of end of intervention (post-intervention)

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Shierk, PhD

CONTACT

[email protected]

4694127172 ext. 1045

Heather Roberts, PhD

CONTACT

[email protected]

214-794-8117

Sponsors and collaborators

Lead sponsor

Texas Scottish Rite Hospital for Children

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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