Clinical trial NCT06347432: Em-power: Maximizing Functional Independence for Children with Severe Cerebral Palsy
Official title: Em-power: Maximizing Functional Independence for Children with Severe Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: Grand Valley State University
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in understanding how to use a power wheelchair
timeFrame: 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)
measure: Change in power wheelchair skill performance
timeFrame: 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:
measure: Change in parental/caregiver perceptions of changes in their children's performance of power wheelchair skill performance
timeFrame: Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)
measure: Change in children's perceptions of changes in their performance of power wheelchair skill performance
timeFrame: Baseline (T0) pre-intervention and immediately after the conclusion of the 8-week intervention period (T1)
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Grand Valley State University
state: Michigan
Study officials:
References: