Acceptability and Efficacy of GO MOVE
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-17
SponsorTexas Scottish Rite Hospital for Children
About this trial
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
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Home Program
BehavioralHome program for 6 weeks (1 hr and 15 minutes per week)
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Go Move Home ProgramExperimental treatment 1 intervention
Trial outcomes
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)
Time frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)Secondary outcomes
1
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.
Time frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)2
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.
Time frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)Other outcomes
1
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
Time frame
within 2 weeks of start of intervention (pre-intervention)2
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
Time frame
within 2 weeks of start of intervention (pre-intervention)3
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
Time frame
within 2 weeks of start of intervention (pre-intervention)4
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
Time frame
within 2 weeks of end of intervention (post-intervention)Sponsors and contacts
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Source ClinicalTrials.gov