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Enrolling by invitationNCT06347432Updated Apr 14, 2026

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

An interventional study of Power wheelchair skills training using the IndieTrainer system in Cerebral Palsy, sponsored by Grand Valley State University. Enrolling by invitation at 1 site in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Grand Valley State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
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Study 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.

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Conditions studied

  • Cerebral Palsy

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03

In context

Cerebral Palsy

1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.

This study's planned enrollment of 16 is below the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Grand Valley State University is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
16 participants (estimated)

Study arms

  • Experimental
    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

    Other: Power wheelchair skills training using the IndieTrainer system

  • No intervention
    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

Interventions

  • OtherPower 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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)

  2. 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.

    Time frame: 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

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

    This outcome will be assessed using the Canadian Occupational Performance Measure to identify, prioritize, and rate parent/caregiver perceptions of children's performance of power wheelchair skills. A total of 4-5 occupational performance issues in the area of power wheelchair skills will be identified and scored on a 1-10 scale, where a "1" is the lowest score and a "10 is the highest score, for both the caregiver's perception of the child's performance and their satisfaction with the child's performance.

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

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

    This outcome will be assessed using the Canadian Occupational Performance Measure to identify, prioritize, and rate child perceptions of their performance of power wheelchair skills. A total of 4-5 occupational performance issues in the area of power wheelchair skills will be identified and scored on a 1-10 scale, where a "1" is the lowest score and a "10 is the highest score, for both the child's perception of their performance and their satisfaction with their performance.

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

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Yes — This study is being funded by the National Institutes of Health (NIH). The NIH requires that research data collected in this study be made available to other researchers. As such, the de-identified data collected in this study will be placed in a repository where it can be accessed by other researchers for future studies.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06347432
Lead sponsor
Grand Valley State University
Responsible party
Lisa Kenyon (Professor, Grand Valley State University) — Principal investigator
First posted
Apr 4, 2024
Start date
Aug 29, 2024
Primary completion
Mar 1, 2027 (estimated)
Completion
Mar 1, 2027 (estimated)
Last update
Apr 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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