Clinical trial NCT06579027: A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia
Official title: A Novel, Child-friendly, Home-based Navigation Training Program Using Joystick-operated Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegia
Cerebral Palsy
Children, Only
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Prior to the start of the study, researchers will conduct a phone screening with the family to confirm their child's eligibility to participate in the study. Once eligibility is confirmed, during the pretest session (week 1), standardized assessments will be conducted to evaluate the child's ability to use their affected arm for different functional activities. During this testing visit, researchers will also attach small sensors on the child's arms and ask them to complete arm movements and functional tasks (e.g., lifting blocks and putting them into a small cup). At the pretest, the child will also be provided 2 activity monitors (similar to wrist watches) to wear on both wrists for 1 week. The activity monitors will allow the researchers to track the child's habitual arm activity over the duration of a week. In addition, caregivers will be asked to complete questionnaires to obtain information on their child's overall health, development, and their ability to use their affected arm for various activities of daily living.

Assessments and questionnaires will be repeated again at the posttest (i.e., at week 8 that corresponds with completion of the 6-week intervention phase) and at 1-month follow-up following intervention completion (i.e., week 12).

Following the pretest, the child will be randomized into one of the training groups (SPEED or CRAFT). During the 6-week intervention phase, the research team will visit the child's home/community 2 times/week to provide the training. Caregivers will be requested to practice 2 additional sessions every week with their child in both groups.

Children in the Strength and Power in upper Extremities through Exploratory Driving (SPEED) training group will engage in multidirectional navigation games and object-based upper extremity quests using the ride-on toys. The toy will be modified to enable operation in a single joystick control mode with the joystick control provided on the child's affected side. The training activities will be designed to encourage children to use their affected arm for training activities. The training will involve children driving through incrementally challenging courses/paths and completing object-based tasks that require use of their affected arm for reaching, grasping, release, and fine manipulation activities. Children will be asked to wear a mitten on their unaffected hand during the sessions. Children in the Creative Rehabilitation for Arm Functional Training (CRAFT) group will engage in seated creative motor games that will encourage use of their affected arm. Training activities will involve stretching and strengthening exercises, building activities (e.g., using Play-doh, blocks, etc.), and art-craft projects, all of which will require the skillful use of the affected arm for reach, grasp, release, and manipulation activities.

Research-delivered sessions in both groups will last around 30-45 minutes. Caregivers will be encouraged to provide 2 more sessions every week lasting about 15-20 minutes/session. The research team will provide caregivers in both groups with the required materials for caregiver sessions. In the SPEED group, the ride-on toy will be left with the family for the duration of the intervention (i.e., 6 weeks). Both researchers and caregivers will be asked to keep track of training sessions (duration, frequency, etc.) using a training log. During the course of the study, children in both groups will continue to receive treatment-as-usual through school or private settings. Families will be asked to log the therapies their child is receiving every week over the course of the study using a training diary (# of times/week, duration of each session, type of therapy received) provided by the researchers. Researchers will video record all testing and researcher-delivered training sessions so that children's performance can be scored later.

Eligibility criteria: Inclusion Criteria:

* Boys and girls between the ages of 3 - 8 years
* Diagnosed with hemiplegia by a medical doctor with clear asymmetry in upper extremity strength and control (i.e., one upper limb is clearly weaker than the other)
* Can maintain a supported sitting position for at least 15 minutes

Exclusion Criteria:

* Only lower limb involvement
* Recent history (within past 6 months) of trauma or surgery or Botox
* Uncorrected blindness/profound visual impairment
* Fixed deformities at wrist or hand
* No active control in affected UE
* Inability to follow 2-step directions
* Weight \> 150 lbs.

Primary outcomes:
measure: Treatment adherence
timeFrame: From start to end of the 6-week intervention phase on a weekly basis
measure: Treatment retention
timeFrame: From date of randomization to date of the final data collection visit with the last participant, assessed over 24 months
measure: Treatment satisfaction
timeFrame: At 8 weeks (i.e., at the posttest visit conducted following completion of the 6-week intervention phase)
measure: Changes in use of affected arm in functional activities
timeFrame: 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)
measure: Changes in hand grip strength
timeFrame: 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 outcomes:
measure: Changes in implementation fidelity during training sessions and factors impacting training delivery
timeFrame: 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)
measure: Changes in child engagement during training sessions
timeFrame: Early (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase
measure: Changes in parent-rated scores on functional use of the affected arm
timeFrame: 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)
measure: Change in affected arm movement control
timeFrame: 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)
measure: Changes in independent navigational control
timeFrame: Early (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase
measure: Changes in habitual arm activity and arm asymmetry
timeFrame: 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)
measure: Changes in maximum UE joint angles and overall range of motion on the affected arm
timeFrame: 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)
Other outcomes:
Locations:
city: Storrs
country: United States
facility: Physical Therapy Program, Department of Kinesiology, University of Connecticut
state: Connecticut
Study officials:
References:
citation: Srinivasan S, Amonkar N, Kumavor PD, Bubela D, Morgan K. Joystick-Operated Ride-On Toy Navigation Training for Children With Hemiplegic Cerebral Palsy: A Pilot Study. Am J Occup Ther. 2024 Jul 1;78(4):7804185070. doi: 10.5014/ajot.2024.050589.
citation: Shahane V, Kumavor PD, Morgan K, Srinivasan S. Fast and Fun: A Pilot Feasibility Study Using Dual Joystick-Operated Ride-on Toys for Upper Extremity Rehabilitation in Children with Hemiplegia. Phys Occup Ther Pediatr. 2024;44(6):844-864. doi: 10.1080/01942638.2024.2360462. Epub 2024 Jun 11.
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citation: Srinivasan S, Amonkar N, Kumavor P, Morgan K, Bubela D. Outcomes Associated with a Single Joystick-Operated Ride-on-Toy Navigation Training Incorporated into a Constraint-Induced Movement Therapy Program: A Pilot Feasibility Study. Behav Sci (Basel). 2023 May 15;13(5):413. doi: 10.3390/bs13050413.
citation: Shahane V, Kumavor P, Morgan K, Friel KM, Srinivasan SM. A protocol for a single-arm interventional study assessing the effects of a home-based joystick-operated ride-on-toy navigation training programme to improve affected upper extremity function and spontaneous use in children with unilateral cerebral palsy (UCP). BMJ Open. 2023 May 9;13(5):e071742. doi: 10.1136/bmjopen-2023-071742.
citation: Amonkar N, Kumavor P, Morgan K, Bubela D, Srinivasan S. Feasibility of Using Joystick-Operated Ride-on-Toys to Promote Upper Extremity Function in Children With Cerebral Palsy: A Pilot Study. Pediatr Phys Ther. 2022 Oct 1;34(4):508-517. doi: 10.1097/PEP.0000000000000944. Epub 2022 Aug 30.