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

NCT06347432 | Enrolling By Invitation

• 1 other identifier: 24-119-H
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in understanding how to use a power wheelchair

  This outcome will be assessed using each participant's score (from a low of Phase 1 to a high of Phase 8) on the Assessment of Learning Powered mobility use. The Assessment of Learning Powered mobility use (ALP) is a process-based measure detailing 8 phases of learning (Phase 1 - Novice to Phase 8 - Expert) within 3 stages: Stage 1 - the Introvert Stage where the child focuses on exploring cause and effect within the function of the power mobility device; Stage 2 - the Explore Sequencing Stage where the child focuses on how to sequence the operations to maneuver the power mobility device; and Stage 3 - the Extrovert Stage where the child is focused on using the power mobility device in daily life. Higher scores therefore indicate a better outcome.

  Baseline (T0) pre-intervention, immediately after the conclusion of the 8-week intervention period (T1), and at the single session retention trial 8 weeks after the end of the intervention period (T2)

• Change in power wheelchair skill performance

  This outcome will be assessed using the Wheelchair Skills Checklist, a task-based measure that evaluates a child's performance of 7 specific power mobility skills using a 3-point ordinal scale from 0-2 where a score of "0" indicates the participant Does Not Perform the skill, a score of "1" indicates that the skill is Emerging, and a score of "2" indicates the participant Performs the Skill. Higher scores therefore indicate a better outcome.

  Baseline (T0) pre-intervention, immediately after the conclusion of the 8-week intervention period (T1), and at the single session retention trial 8 weeks after the end of the intervention period (T2)

Secondary Outcomes (2)

• Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance

  Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)

• Change in children's perceptions of changes in their performance of power wheelchair skill performance

  Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)

Study Arms (2)

Group A: Experimental Group

EXPERIMENTAL

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

Other: Power wheelchair skills training using the IndieTrainer system

Group B: Wait List Control Group

NO INTERVENTION

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

Interventions

Power wheelchair skills training using the IndieTrainer system 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 A: Experimental Group

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Grand Valley State University: lead

Study Sites (1)

Grand Valley State University

Grand Rapids, Michigan, 49503, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

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: Professor

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: August 29, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)