A Novel Program Using Ride-on Toys to Improve Upper Extremity Function in Children With Hemiplegia

NCT06579027 | Recruiting FDA Device

• 2 other identifiers: 23-10-800-9101R21HD109605-01A1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Cerebral Palsy; Children, Only

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Changes in implementation fidelity during training sessions and factors impacting training delivery

  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

  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

  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

  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 (week 1), Mid (week 3), and Late (week 6) training sessions within the 6-week intervention phase

Study Arms (2)

SPEED (Strength and Power in upper Extremities through Exploratory Driving)

EXPERIMENTAL

Children will receive training focused on improving affected arm function using modified, joystick-operated ride-on toys. The commercial ride-on toys will be modified to allow operation in a single joystick control mode provided on the child's affected side. The manualized SPEED sessions will involve 2 components: (a) Multidirectional navigational games where children will use their affected UE to drive and maneuver the toy and (b) Object-based UE tasks completed at intermediate stops/stations during navigation. Navigational opportunities will encourage children to navigate through paths of different shapes, sizes, and complexity levels (e.g., straight, circle, diamond, slalom, obstacle courses etc.) Object-based tasks will encourage functional UE movement patterns during object interactions such as reaching, throwing, catching, pulling, pushing, lifting, knocking, holding, grasping, opening, closing, release, and manipulation.

Device: SPEED Training

CRAFT (Creative Rehabilitation for Arm Functional Training)

ACTIVE COMPARATOR

Children will engage in seated creative motor games focused on promoting gross and fine motor UE function. Training sessions will encourage use of the affected UE during unimanual and bimanual activities. Each training session will involve the following components: (a) Stretching exercises and (b) Task-oriented strengthening activities. Stretching exercises will involve range of motion exercises to encourage active warmup of proximal (shoulder, elbow) and distal (wrist, hand) UE muscles and movement dissociation. Task-oriented strengthening will involve use of the affected UE as a mobilizer and a stabilizer during building (e.g., Play-Doh, blocks, puzzles) and art-craft activities (e.g., folding, cutting, pasting, coloring). Task-oriented practice will emphasize skills such as reaching, grasping, release, and manipulation of training supplies.

Behavioral: CRAFT Training

Interventions

SPEED Training DEVICE

Children will use ride-on toys controlled using their affected arm to navigate through their environment and complete playful theme-based challenges. Children will use their affected UE during navigation to start and stop the toy, move steadily forward and backward, turn to the right and left, perform 180° and 360° turns to either side, and avoid obstacles. Children will complete object-based UE tasks requiring gross and fine motor control at intermediate stops during navigation. Navigational tasks will be progressed by increasing complexity of paths (straight to slalom paths needing more directional changes), spaces (wide to narrow spaces), and precision (obstacle courses and mazes requiring skillful navigation, motor planning, and route finding). Object-based tasks will be progressed in terms of force requirements (small to large forces), range of motion (near to far reaches), precision (manipulation of large to small objects), and speed of movements (slow to fast).

Also known as: Strength and Power in upper Extremities through Exploratory Driving

SPEED (Strength and Power in upper Extremities through Exploratory Driving)

CRAFT Training BEHAVIORAL

Children will engage in predominantly seated activities based on conventional occupational therapy to promote unimanual and bimanual UE function. Training sessions will be based on playful child-friendly themes (e.g., dinosaurs, space exploration, aquatic theme, etc.) and all training activities will incorporate the session theme. Activities will involve practice of functional gross and fine motor UE movement patterns that children typically use during daily life. Training will emphasize the use of the affected UE in different roles (i.e., stabilizer, mobilizer, and active and passive assist) during warm-up, building, and art-craft activities. The training will be progressed in terms of forces needed, range of motion, precision, and movement speed.

Also known as: Creative Rehabilitation for Arm Functional Training

CRAFT (Creative Rehabilitation for Arm Functional Training)

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Connecticut: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Physical Therapy Program, Department of Kinesiology, University of Connecticut

Storrs, Connecticut, 06269, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 38836619 BACKGROUND

• 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.

  PMID: 38863174 BACKGROUND

• Srinivasan S, Kumavor PD, Morgan K. A Pilot Feasibility Study on the Use of Dual-Joystick-Operated Ride-on Toys in Upper Extremity Rehabilitation for Children with Unilateral Cerebral Palsy. Children (Basel). 2024 Mar 29;11(4):408. doi: 10.3390/children11040408.

  PMID: 38671624 BACKGROUND

• Srinivasan S, Kumavor P, Morgan K. A Training Program Using Modified Joystick-Operated Ride-on Toys to Complement Conventional Upper Extremity Rehabilitation in Children with Cerebral Palsy: Results from a Pilot Study. Bioengineering (Basel). 2024 Mar 23;11(4):304. doi: 10.3390/bioengineering11040304.

  PMID: 38671726 BACKGROUND

• Srinivasan S, Amonkar N, Kumavor PD, Bubela D. Measuring Upper Extremity Activity of Children With Unilateral Cerebral Palsy Using Wrist-Worn Accelerometers: A Pilot Study. Am J Occup Ther. 2024 Mar 1;78(2):7802180050. doi: 10.5014/ajot.2024.050443.

  PMID: 38478583 BACKGROUND

• 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.

  PMID: 37232651 BACKGROUND

• 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.

  PMID: 37160396 BACKGROUND

• 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.

  PMID: 36044637 BACKGROUND

MeSH Terms

Conditions

Hemiplegia; Cerebral Palsy

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Central Study Contacts

Sudha M Srinivasan, PhD

CONTACT

860-486-6192; sudha.srinivasan@uconn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: September 26, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: All scientific data generated from this project will be made available as soon as possible, and no later than the time of publication or the end of the funding period, whichever comes first.

Locations

US (1)