Enrolling by invitation NCT06347432
Em-power: Maximizing Functional Independence for Children With Severe Cerebral Palsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Power wheelchair skills training using the IndieTrainer system.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy. Basic parameters: 5 years — 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other 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 activitie
Primary outcome measures
- 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)]
- Change in power wheelchair skill performance [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 outcome measures (2)
- Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance [Time frame: 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 [Time frame: Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Grand Valley State University — Grand Rapids
Identifiers
NCT: NCT06347432 · 24-119-H