- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07342348
Using Power Mobility Training to Promote Arm & Hand Function in Children With Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Lisa K. Kenyon, PT, DPT, PhD, PCS
- Phone Number: 616-331-5653
- Email: kenyonli@gvsu.edu
Study Locations
-
-
Michigan
-
Grand Rapids, Michigan, United States, 49504
- Recruiting
- Grand Valley State University
-
Contact:
- Lisa K. Kenyon, PT, DPT, PhD, PCS
- Phone Number: 616-331-5653
- Email: kenyonli@gvsu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm- and hand-use focused power mobility training group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canadian Occupational Performance Measure
Time Frame: From enrollment to the end of treatment at 6 weeks
|
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
Time Frame: From enrollment to the end of treatment at 6 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shriner's Hospital Upper Extremity Evaluation
Time Frame: From enrollment to the end of treatment at 6 weeks
|
The Shriner's Hospital Upper Extremity Evaluationis a 16-item video-recorded test to assess spontaneous use and dynamic alignment of the affected UE during bimanual tasks.
Higher scores indicate better outcomes.
|
From enrollment to the end of treatment at 6 weeks
|
|
Grip strength
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Children's grip strength will be measured bilaterally.
Higher values indicate a better outcome.
|
From enrollment to the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lisa K. Kenyon, PT, DPT, PhD, PCS, Grand Valley State University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26-065-H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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