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NCT Number: NCT07220590

Implementing Powered Mobility in Early Childhood Settings for Children With Cerebral Palsy

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. Complete surveys, interviews, and observations about their experiences

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Key information

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Regional Education Service District, Hillsboro, Oregon, United States

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About this study

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:

  • Identify provider needs and barriers through surveys and focus groups with providers.
  • Co-design a training program with input from a Community Advisory Board that includes clinicians, families, administrators and researchers. This process ensures that the training reflects real-world challenges and priorities.
  • Conduct a feasibility trial to test the training program with providers and families of young children with CP.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Children:

  • 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

Treatment and study plan

Therapist Training on Powered Mobility Implementation

Behavioral

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.

Powered Mobility Intervention for Child-Caregiver Dyads

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany M Sloane, PT, DPT, PhD

CONTACT

[email protected]

503-494-3232

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

Bridging the Gap: Implementing A Powered Mobility Intervention Into Early Childhood Settings for Young Children With Cerebral Palsy (GMFCS IV-V)

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 24, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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