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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Grand Valley State University
Study ID
NCT06347432
Status
Enrolling By Invitation

Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
5 Years - 17 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Aug 29, 2024
Status verified
Mar 2026
Primary completion
Mar 1, 2027
Completion
Mar 1, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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
  • 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

Primary Outcome Measure

Change in understanding how to use a power wheelchair [ 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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Grand Valley State UniversityGrand RapidsMichigan49503-

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