NCT07220590 · Oregon Health and Science University
Implementing Powered Mobility in Early Childhood Settings for Children With Cerebral Palsy
What this study is about
The goal of this clinical trial is to learn if a therapist training program can help providers in Part C Early Childhood Settings use powered mobility (PM) with young children who have cerebral palsy (Gross Motor Function Classification System Levels IV-V). The study will also look at whether this training is practical and useful for therapists, families, and children.
View original scientific description
The goal of this clinical trial is to learn if a therapist training program can help providers in Part C Early Childhood Settings use powered mobility (PM) with young children who have cerebral palsy (Gross Motor Function Classification System Levels IV-V). The study will also look at whether this training is practical and useful for therapists, families, and children. The main questions it aims to answer are: 1. Can therapists successfully use the training to provide powered mobility interventions in home and early childhood settings? 2. Do families and children find the intervention acceptable and helpful? 3. What benefits do children show in mobility, participation, and engagement after using powered mobility? In this study, therapists and families will: 1. Take part in a training program about how to use powered mobility with young children 2. Use powered mobility devices (Permobil Explorer Mini) with children during everyday routines 3.
Interventions
BEHAVIORAL
Therapist Training on Powered Mobility Implementation
Therapists participate in a structured, evidence-based training on implementing powered mobility interventions for children with cerebral palsy (GMFCS IV-V) in early childhood settings. Training consists of one to two days of in-person sessions focused on knowledge transfer, therapist confidence, self-efficacy, and use of caregiver coaching and routines-based strategies. The training is co-designed with a community advisory board of administrators, therapists, and caregivers to ensure contextual relevance and feasibility.
BEHAVIORAL
Powered Mobility Intervention for Child-Caregiver Dyads
Following therapist training, participating therapists deliver a six-month powered mobility intervention to children with cerebral palsy (GMFCS IV-V) and their caregivers. Therapists conduct twelve biweekly home-based sessions focused on providing mobility opportunities, caregiver coaching, and integration of powered mobility into daily routines. The intervention uses the Permobil Explorer Mini device to facilitate self-initiated mobility. All sessions are audio-video recorded for fidelity monitoring and qualitative analysis.
Primary outcome measures
Intervention Acceptability, Appropriateness, and Feasibility
Time frame: Post-intervention (after 6 months of intervention).
Therapist and caregiver perceptions of the powered mobility intervention's acceptability, appropriateness, and feasibility, measured using three validated implementation outcome measures: Acceptability of Intervention Measure (AIM) Intervention Appropriateness Measure (IAM) Feasibility of Intervention Measure (FIM) Each measure consists of 4 items rated on a 5-point Likert scale (1 = completely disagree to 5 = completely agree). Total scores range from 4 to 20 for each measure, with higher scores indicating greater acceptability, appropriateness, or feasibility of the intervention. Mean scores will be calculated for each scale.
Therapist Knowledge Transfer, Confidence, and Self-Efficacy
Time frame: Pre-training and immediately post-training (within 1 week).
Change in therapist knowledge, confidence, and self-efficacy related to powered mobility implementation, measured using a study-specific therapist questionnaire administered via REDCap. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Mean scores will be calculated, with higher scores indicating greater knowledge, confidence, and self-efficacy. Change scores will be computed from pre-training to post-training.
Caregiver Feasibility of Device and Strategy Use
Time frame: Biweekly during 6-month intervention period.
Caregiver-reported feasibility of using the powered-mobility device and implementing facilitating strategies, assessed biweekly with a brief questionnaire. Frequency and mean feasibility ratings over time.
Therapist Intervention Fidelity
Time frame: Per intervention session throughout the 6-month intervention period.
Degree to which therapists deliver the powered mobility intervention as intended, assessed through video-coded observations using a structured fidelity checklist and established coding framework. Fidelity ratings capture adherence, dosage, quality of delivery, participant responsiveness, and program differentiation. Mean percentage of fidelity checklist items completed as intended across sessions.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnosis of cerebral palsy or similar motor impairment
- Gross Motor Function Classification System (GMFCS) Levels IV-V
- Age 12 to 32 months at enrollment
- Enrolled in early intervention services Caregivers:
- Parent or legal guardian of an enrolled child participant
- Age 18 years or older
- English- or Spanish-speaking
- Able and willing to participate in home-based data collection, including caregiver coaching sessions, completion of surveys, and video-recorded sessions
- Able to provide informed consent Therapists:
- Licensed physical therapist or occupational therapist
- Employed at participating early intervention or early childhood special education settings
- Provide services to children with cerebral palsy or motor delays
- No prior powered mobility intervention training required
- Willing to complete powered mobility implementation training and participate in study assessments
Exclusion criteria
- Inability or unwillingness to provide informed consent
- Inability to complete required study procedures
Where
- Hillsboro, Oregon
- Portland, Oregon
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations