An interventional study of Therapist Training on Powered Mobility Implementation and Powered Mobility Intervention for Child-Caregiver Dyads in Cerebral Palsy Children, Motor Disabilities and Developmental Disability, sponsored by Oregon Health and Science University. Recruiting at 3 sites in United States. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Oregon Health and Science University · Not applicable, Interventional, and Treatment
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:
In this study, therapists and families will:
Cerebral palsy (CP) is the most common cause of physical disability in childhood. Children classified at Gross Motor Function Classification System (GMFCS) Levels IV-V experience significant limitations in mobility and typically require assistive technology to move independently. These early months, between 12-36 months, are a critical period for brain development and learning. Without access to independent mobility, children with CP have fewer opportunities to explore, communicate, and engage socially, which can contribute to secondary developmental delays.
Power mobility (PM) devices, such as the Permobil Explorer Mini, provide opportunities for self-initiated exploration of a child's environment. Research has shown that access to PM in early childhood can promote cognitive, social, and motor development, while also supporting participation in family and community life. Despite this growing evidence base, PM use in Part C Early Childhood Settings is infrequent and inconsistent. Many families never receive the option of PM during their child's first years. Barriers include a lack of provider training, limited availability of devices, uncertainty about service delivery models, and the perception that PM should be delayed until school age.
This study directly addresses these gaps by developing and testing a training program for Early Childhood Setting providers to deliver PM interventions with young children with CP (GMFCS IV-V). The project uses a community-engaged, implementation science approach to ensure that the intervention is not only clinically meaningful but also feasible and sustainable within real-world Part C Early Childhood Setting systems.
The research is guided by three aims:
The feasibility trial will combine implementation and child-level outcomes in an effectiveness-implementation hybrid design. Implementation outcomes will include acceptability, appropriateness, feasibility, and fidelity, using validated measures such as the Acceptability of Intervention Measure (AIM), Feasibility of Intervention Measure (FIM), and Implementation Appropriateness Measure (IAM). Fidelity will be examined through session recordings and coding of adherence to intervention strategies.
The intervention itself consists of therapist training in PM use, assessment, and caregiver coaching. Providers will be introduced to the Explorer Mini and will learn strategies to embed mobility into family routines. Therapists will then coach families to use PM with their children during everyday activities, both in the home and community. The emphasis is on real-world use, giving children opportunities to explore, make choices, and participate in their environments.
Child outcomes will include mobility, engagement, and participation, measured through caregiver report, standardized assessments, and observational coding of video-recorded sessions. Family experiences will be assessed through surveys and semi-structured interviews, to better understand acceptability and perceived benefits of PM.
This study is expected to generate critical pilot data on how PM interventions can be implemented in Part C Early Childhood settings, a setting where they are currently underutilized. By focusing on both therapist training and family engagement, this project bridges the gap between evidence and practice. Findings will inform larger-scale trials and lay the groundwork for integrating PM into standard Early Childhood setting services, ensuring that children with CP and significant motor impairments have earlier opportunities to move, explore, and participate fully in daily life.
230 studies on the registry are indexed under Developmental Disabilities; 65 are open to participants now.
This study's planned enrollment of 70 is above the median of 60 across 150 interventional studies indexed under Developmental Disabilities.
Browse Developmental Disabilities studies →Oregon Health and Science University is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 39 (75%) have results posted.
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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.
Children:
Caregivers:
Therapists:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This mixed-methods feasibility trial includes one experimental arm in which all participants receive the powered mobility intervention following a structured therapist training. Trained physical and occupational therapists participate in one to two days of in-person training to learn how to implement the intervention with children with cerebral palsy (GMFCS IV-V) and their caregivers in early childhood settings. Following training, therapists identify eligible child-caregiver dyads from their caseloads and conduct twelve biweekly home-based intervention sessions over six months. Each session focuses on mobility opportunities, caregiver coaching, and integration of powered mobility into daily routines using the Permobil Explorer Mini device. All sessions are video recorded for fidelity monitoring and qualitative analysis.
Behavioral: Therapist Training on Powered Mobility Implementation · Behavioral: Powered Mobility Intervention for Child-Caregiver Dyads
Understanding barriers and facilitators to power mobility use through a mixed-methods approach: Survey, observations, and listening sessions/focus groups
Prioritizing determinants, co-developing implementation strategies and evaluation measures, co-developing therapist training to be piloted in Aim 3.
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.
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.
Intervention Acceptability, Appropriateness, and Feasibility
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.
Time frame: Post-intervention (after 6 months of intervention).
Therapist Knowledge Transfer, Confidence, and Self-Efficacy
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.
Time frame: Pre-training and immediately post-training (within 1 week).
Caregiver Feasibility of Device and Strategy Use
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.
Time frame: Biweekly during 6-month intervention period.
Therapist Intervention Fidelity
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.
Time frame: Per intervention session throughout the 6-month intervention period.
Not enrolling at this site.
Plan to share: No — This is a small, early-stage feasibility study involving young children with cerebral palsy. Given the sensitive nature of pediatric data and the limited sample size, individual participant data will not be shared outside of the study team. However, de-identified, aggregate findings will be disseminated through peer-reviewed publications, conference presentations, and collaboration with community and clinical partners
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