NCT06048419

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Feb 2024Dec 2026

First Submitted

Initial submission to the registry

August 29, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

February 20, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

August 29, 2023

Last Update Submit

March 6, 2025

Conditions

Keywords

home program

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Goal Attainment Scale (GAS) Light

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

  • Assisting Hand Assessment (AHA) (optional)

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

Other Outcomes (5)

  • Demographic information

    within 2 weeks of start of intervention (pre-intervention)

  • Gross Motor Function Classification System (GMFCS)

    within 2 weeks of start of intervention (pre-intervention)

  • Manual Ability Classification Scale (MACS)

    within 2 weeks of start of intervention (pre-intervention)

  • +2 more other outcomes

Study Arms (1)

Go Move Home Program

EXPERIMENTAL

Goal driven home program

Behavioral: Home Program

Interventions

Home ProgramBEHAVIORAL

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

Go Move Home Program

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scottish Rite for Children

Frisco, Texas, 75034, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Angela Shierk, PhD

    Scottish Rite for Children

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Shierk, PhD

CONTACT

Heather Roberts, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective cohort
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Scientist

Study Record Dates

First Submitted

August 29, 2023

First Posted

September 21, 2023

Study Start

February 20, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations