NCT07342348

Brief Summary

Approximately 40% of children with ambulatory cerebral palsy have significant functional asymmetries in arm and hand function. Children with these significant functional asymmetries have difficulties using their more-affected (less preferred) arm and hand in daily activities, especially true in daily activities requiring bilateral hand and arm use. Recent research suggests that power mobility training provided via a ride-on toy may help to motivate these children to use their less preferred arm and hand. This research further notes that participation in power mobility training designed to encourage a child to use their less preferred arm and hand also may help to improve their arm and hand function and use in their daily activities. This exploratory study seeks to explore an innovative intervention using arm- and hand-use focused power mobility training activities, encompassing both navigational/maneuvering activities and embedded play-based reaching and grasping activities. During power mobility training activities, children will be asked to wear a soft mitten or sock on their preferred hand to help them remember to use their less preferred hand and arm. The purpose of this exploratory study is to examine both the effect and feasibility of a 6-week laboratory-based arm-and hand-use focused power mobility training program.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
44mo left

Started Jan 2026

Longer than P75 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 Progress8%
Jan 2026Dec 2029

First Submitted

Initial submission to the registry

January 8, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

January 19, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

January 8, 2026

Last Update Submit

January 8, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Canadian Occupational Performance Measure

    The Canadian Occupational Performance Measure rates parent/caregiver perceptions of their child's performance of 5 arm and hand skills. Each skill is rated from a minimum of 1 to a maximum of 10. A higher score indicates a better outcome. The total score on all 5 items ranges from a minimum of 5 to a maximum of 50. A higher score indicates a better outcome.

    From enrollment to the end of treatment at 6 weeks

  • ABILHAND-Kids-CP Questionnaire

    The ABILHAND measures parents' perceptions of their child's manual ability and provides a comprehensive evaluation of the child's functional arm and hand ability. Parents estimate their child's ease or difficulty in performing 17 activities. Each activity is rated using a 3-point Likery scale as follows: 'Impossible=0, Difficult=1, Easy=2. Higher scores indicate a better outcome.

    From enrollment to the end of treatment at 6 weeks

Secondary Outcomes (2)

  • Shriner's Hospital Upper Extremity Evaluation

    From enrollment to the end of treatment at 6 weeks

  • Grip strength

    From enrollment to the end of treatment at 8 weeks

Study Arms (1)

Arm- and hand-use focused power mobility training group

EXPERIMENTAL

These arm- and hand-use focused power mobility training activities will be provided via a ride-on toy and will encompass both navigational/maneuvering activities and play-based reaching and grasping activities embedded into the navigational/maneuvering activities. During power mobility training activities, children will be asked to wear a soft mitten or sock on their preferred hand to help them remember to use their less preferred hand and arm.

Other: Arm- and hand-use focused power mobility training

Interventions

These arm- and hand-use focused power mobility training activities will encompass both navigational/maneuvering activities and play-based reaching and grasping activities embedded into the navigational/maneuvering activities. During power mobility training activities, children will be asked to wear a soft mitten or sock on their preferred hand to help them remember to use their less preferred hand and arm.

Arm- and hand-use focused power mobility training group

Eligibility Criteria

Age3 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosis of cerebral palsy
  • Demonstrates significantly less functional use of one arm and hand
  • Can get on and off the a ride-on toy with minimal assistance from the researchers
  • Can maintain a sitting position on the a ride-on toy
  • Has sufficient functional vision to safely maneuver the a ride-on toy
  • Has their own bicycle helmet that fits them well and is in good working condition

You may not qualify if:

  • Hand or arm surgery within the past 6 months
  • Their weight exceeds device limits (more than 120 pounds)
  • They do not demonstrate sufficient balance and control in sitting to safely use the ride-on toy
  • If they cannot safely participate in arm- and hand-use focused power mobility training activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49504, United States

RECRUITING

Related Publications (3)

  • Srinivasan SM, Kataria K, Yorns W Jr, Moore TE, Yoo C, Kumavor PD, Morgan K, Friel K. A novel program including ride-on toys to improve upper extremity function in children with hemiplegia: a randomized controlled trial. Disabil Rehabil Assist Technol. 2026 Jan;21(1):173-186. doi: 10.1080/17483107.2025.2534436. Epub 2025 Jul 21.

    PMID: 40689868BACKGROUND
  • Srinivasan S, Shahane V, Kumavor P, Morgan K, Friel K. Joystick-Operated Ride-On Toys as a Therapy Adjunct for a Child With Hemiplegia: A Case Report. Pediatr Phys Ther. 2025 Jul 1;37(3):371-379. doi: 10.1097/PEP.0000000000001209. Epub 2025 Jun 27.

    PMID: 40587602BACKGROUND
  • 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: 36044637BACKGROUND

MeSH Terms

Conditions

Cerebral PalsyHemiplegia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lisa K. Kenyon, PT, DPT, PhD, PCS

    Grand Valley State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa K. Kenyon, PT, DPT, PhD, PCS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2026

First Posted

January 15, 2026

Study Start

January 19, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations