Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy

NCT ID: NCT06347432

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-29
• Study Completion Date: 2027-03-31

Brief Summary

For children with severe cerebral palsy, a powered wheelchair (PWC) may provide their only option for functional mobility and independence. PWC use is often restricted to a small percentage of children who can quickly demonstrate proficient PWC skills within a single 30-minute PWC trial. This 2-arm, parallel group, single blinded, pre-test-post-test randomized controlled trial will test our hypothesis that an 8-week PWC skills training intervention will produce greater improvements in children's PWC skills capacity immediately after the intervention and at an 8-week follow-up assessment.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A: Experimental Group

Group A: The Experimental Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer System following T0 baseline testing

Group Type: EXPERIMENTAL

Power wheelchair skills training using the IndieTrainer system

Intervention Type: OTHER

The IndieTrainer system will be used to provide the power wheelchair (PWC) skills training sessions. The IndieTrainer is comprised of a mobility device and an array of video-based gamified training modules designed to facilitate PWC training. The IndieTrainer mobility device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. Principles outlined in the Assessment of Learning Powered mobility use (ALP) Facilitating Strategies for each ALP Assessment phase will guide the intervention sessions.

Group B: Wait List Control Group

Group B: The Wait List Control Group will receive the 8-week evidence-based PWC skills training using the IndieTrainer System following T2 testing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Power wheelchair skills training using the IndieTrainer system

The IndieTrainer system will be used to provide the power wheelchair (PWC) skills training sessions. The IndieTrainer is comprised of a mobility device and an array of video-based gamified training modules designed to facilitate PWC training. The IndieTrainer mobility device temporarily converts a manual wheelchair into a powered wheelchair, thereby allowing children to remain in their own manual wheelchair and use their own custom seating system during power wheelchair skills training activities. Principles outlined in the Assessment of Learning Powered mobility use (ALP) Facilitating Strategies for each ALP Assessment phase will guide the intervention sessions.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of severe CP (Gross Motor Function Classification System Level IV or V)
• Inability to functionally walk or functionally propel a manual wheelchair as assessed by the Principal Investigator a licensed physical therapist
• Demonstrate cause and effect skills in the IndieTrainer consistent with an Assessment of Learning Powered mobility use (ALP Assessment) Phase 4 or higher (i.e., understand that they are moving the IndieTrainer using the switch(es) or joystick) as assessed by the Principal Investigator, a licensed physical therapist.
• In addition, one parent/caregiver must be conversant in English and be able to provide their child's medical and health history and be willing to take on the parent participant role.

Exclusion Criteria

• The inability to sit in their own manual wheelchair or adaptive stroller for 60 minutes (as this would preclude them safely using the IndieTrainer System for the 60-minute intervention sessions)
• Their manual wheelchair or adaptive stroller cannot be safely used with the IndieTrainer System
• They already have an individually prescribed power wheelchair
• If the Principal Investigator, a licensed physical therapist, determines that based on the child's medical and health history, that they cannot safely participate in power wheelchair skills training.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Grand Valley State University

OTHER

Sponsor Role: lead

Responsible Party

Lisa Kenyon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Grand Valley State University

Grand Rapids, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Kenyon, PhD

Role: CONTACT

kenyonli@gvsu.edu

616-331-5653

Facility Contacts

Lisa K Kenyon, PT, DPT, PhD

Role: primary

kenyonli@gvsu.edu

616-331-5653

Other Identifiers

24-119-H

Identifier Type: -

Identifier Source: org_study_id