A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia
NCT Number: NCT06579027
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemiplegia|Cerebral Palsy|Children, Only
Interventions: DEVICE: SPEED Training|BEHAVIORAL: CRAFT Training
Sponsor: University of Connecticut
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sex: ALL
Age: CHILD
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2026-09-01
Locations: Physical Therapy Program, Department of Kinesiology, University of Connecticut, Storrs, Connecticut, 06269, United States

Summary:
The purpose of this study is to assess the feasibility and utility of 2 types of play-based training programs co-delivered by researchers and caregivers within home/community settings to promote arm function among 3-to-8-year-old children with hemiplegia. Specifically, investigators will assess the feasibility of implementation and acceptance/satisfaction associated with a researcher-caregiver co-delivered community-based training program involving either joystick-operated powered ride-on toys (SPEED training) or creative upper extremity training (CRAFT training).

The investigators will also compare the effects of these 2 types of training programs on children's arm motor function and spontaneous use of their affected arm during daily activities.

Primary Outcome Measures: Treatment adherence, Researchers and caregivers will maintain training logs to document the frequency (# of sessions/week) and duration (time per session) of training sessions. In the SPEED group, the ride-on toy will collect data on amount of device use during training sessions., From start to end of the 6-week intervention phase on a weekly basis|Treatment retention, Researchers will report treatment retention (# of families who withdrew). The researchers will track the # of families who withdrew from the study, the timepoint within the study timeline of withdrawal, and the reasons for withdrawal., From date of randomization to date of the final data collection visit with the last participant, assessed over 24 months|Treatment satisfaction, The researchers will use the 16-item Physical Activity Enjoyment Scale (PAES) with children (delivered in an interview format) scored on a Likert scale of 1 (Disagree a lot) to 5 (Agree a lot) at posttest to assess perceived competence, pleasure/enjoyment, control, and sense of success. Caregivers will complete exit questionnaires/interviews to assess perceived program satisfaction, burden, willingness to continue training beyond the study, likelihood of recommending training to others, and child motivation/engagement during the training., At 8 weeks (i.e., at the posttest visit conducted following completion of the 6-week intervention phase)|Changes in use of affected arm in functional activities, The Shriner's Hospital Upper Extremity Evaluation (SHUEE) is a video-based test that analyzes affected UE use spontaneously and on tester demand during 16 bimanual tasks in 3-18-year-olds. It has 3 components: spontaneous functional analysis (SFA), dynamic positional analysis (DPA), and grasp-release analysis (GRA), scored on a 2- to 6-point ordinal scale. The SHUEE assessment includes evaluation of spontaneous use of the involved UE and segmental alignment of the affected UE during performance of tasks on demand, for example, unscrewing a bottle cap, removing money from a wallet, putting socks on, etc. The SFA is scored on a scale from 0 to 5 where higher ratings indicate better performance. The DPA is scored on a scale from 0 to 3, where higher ratings indicate better performance. The GRA is scored on scale from 0 to 1, where higher ratings indicate better performance., Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)|Changes in hand grip strength, A calibrated digital Jamar dynamometer will be used to measure grip strength while seated with forearm supported. Following a single sub-maximal practice trial, a single maximal trial of 3-4 seconds will be collected from each hand., Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of the intervention phase)
Secondary Outcome Measures: Changes in implementation fidelity during training sessions and factors impacting training delivery, In both training groups, a coder naïve to study aims will randomly choose and code videos (one each of early, mid, and late researcher-delivered sessions) using custom-designed fidelity checklists to assess adherence to the manualized training protocols. Caregivers will fill exit questionnaires at posttest to report ease of implementation of the training programs, barriers and facilitators related to session delivery, and adequacy of researcher support to deliver caregiver sessions., Early (week 1), Mid (week 3), and late (week 6) training sessions within the 6-week intervention phase and at week 8 (posttest following completion of the intervention phase)|Changes in child engagement during training sessions, The researchers will code 1 early, 1 mid, and 1 late researcher-administered session during the intervention phase in both groups (using Datavyu video coding software) to assess the child's affect and attention to the task. Specifically, in terms of affect, for each training session (early, mid, and late), researchers will code the percent duration of session spent in positive and negative affective states. In addition, training sessions (early, mid, and late session) will be coded for the child's attention patterns. The research team will code the percent duration of the session that the child attended towards task-appropriate and task-inappropriate targets. Specifically, investigators will code for attention directed towards: (a) task, (b) social partners, and (d) elsewhere., Early (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase|Changes in parent-rated scores on functional use of the affected arm, The ABILHAND-Kids is a valid and reliable parent-rated questionnaire assessing parent perceptions of their child's level of ease or difficulty in performing 21 manual activities independently over the last 3 months. The 21 manual activities are rated by parents on a 3-point scale of "impossible", "difficult", or "easy". Items become increasingly difficult in terms of required bimanual function. Investigators will report changes in logit scores over the course of the training program., Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)|Change in affected arm movement control, The Quality of Upper Extremity Skills Test (QUEST) is a criterion-referenced, valid, and reliable measure for use between 18 months-12 years to assesses quality of UE function in 4 domains: dissociated movements, grasp, protective extension, and weight bearing. The tool includes 36 items that evaluate movement patterns and hand function in children with Cerebral Palsy and are scored on a dichotomous scale (minimum value = 1, maximum value = 2), with higher scores indicating better performance. The research team will report total scores and 4 sub-domain scores on the QUEST., Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)|Changes in independent navigational control, Early, mid, \& late training sessions (one session at each time point) of children in the SPEED group will be coded for percent duration of session engaged in assisted (child needs trainer-provided manual assistance) versus independent (child is able to drive the toy unassisted) navigation., Early (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase|Changes in habitual arm activity and arm asymmetry, Children will be asked to wear 2 wrist activity monitors (ActiGraph devices), one each on both wrists, for the duration of 1 week, at 3 time points : (a) baseline/pretest, (b) posttest following completion of the 6-week intervention phase, and (c) followup (i.e., 1 month following intervention completion). Children will be asked to wear the monitors for a period of 1 week at all 3 time points. Children will be asked to wear the monitors continuously when awake and while sleeping (minimum of 4 days - 1 weekend day and 3 weekdays) over the course of the week. Investigators will report extent of asymmetry in affected versus unaffected arm use across the time points., Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)|Changes in maximum UE joint angles and overall range of motion on the affected arm, Movement kinematics will be collected from both UEs during the following tasks: (a) range of motion tasks involving shoulder, elbow, forearm, and wrist movements (adapted from tasks from the QUEST and SHUEE tests) and (b) sequential bimanual tasks adapted from motor tests (i.e., clean-up task with 6 blocks requiring the child to grasp each block, transfer to the other hand, and release into a small cup). Sensors (Inertial Measurement Units (IMUs)) will be placed on both hands, both forearms, both arms, and the C7 spinous process. The research team will report maximum joint angles and overall joint range of motion., Baseline (i.e., pretest conducted in week 1), at 8 weeks (i.e., at posttest after completion of the 6-week intervention), and at 12 weeks (i.e., at 1-month followup after the end of intervention phase)