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

NCT07220590 | Not Yet Recruiting DMC

• 1 other identifier: 1K23HD119273-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Can therapists successfully use the training to provide powered mobility interventions in home and early childhood settings?
2. 2.Do families and children find the intervention acceptable and helpful?
3. 3.What benefits do children show in mobility, participation, and engagement after using powered mobility?
4. 4.Take part in a training program about how to use powered mobility with young children
5. 5.Use powered mobility devices (Permobil Explorer Mini) with children during everyday routines
6. 6.Complete surveys, interviews, and observations about their experiences

Conditions

Developmental Disability; Rehabilitation; Early Intervention; Assistive Technology; Motor Disabilities; Cerebral Palsy Children

Keywords

Power Mobility; Implementation Science; Community-engaged research; Caregiver coaching; Pediatric Rehabilitation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Per intervention session throughout the 6-month intervention period.

Study Arms (1)

Powered Mobility Intervention

EXPERIMENTAL

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

Interventions

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

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.

Powered Mobility Intervention

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability or unwillingness to provide informed consent
• Inability to complete required study procedures

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (3)

Northwest Regional Education Service District

Hillsboro, Oregon, 97124, United States

Location

Multnomah Early Childhood Program

Portland, Oregon, 97230, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (5)

• Sabet A, Feldner H, Tucker J, Logan SW, Galloway JC. ON Time Mobility: Advocating for Mobility Equity. Pediatr Phys Ther. 2022 Oct 1;34(4):546-550. doi: 10.1097/PEP.0000000000000939. Epub 2022 Aug 4.

  PMID: 35943383 BACKGROUND

• Sloane BM, Kenyon LK, Logan SW, Feldner HA. Caregiver perspectives on powered mobility devices and participation for children with cerebral palsy in Gross Motor Function Classification System level V. Dev Med Child Neurol. 2024 Mar;66(3):333-343. doi: 10.1111/dmcn.15718. Epub 2023 Jul 28.

  PMID: 37515376 BACKGROUND

• Feldner HA, Logan SW, Otieno S, Fragomeni A, Kono C, Riordan K, Sloane B, Kenyon LK. Short-Term Powered Mobility Intervention Is Associated With Improvements in Development and Participation for Young Children With Cerebral Palsy: A Randomized Clinical Trial. Phys Ther. 2025 Jan 8;105(1):pzae152. doi: 10.1093/ptj/pzae152.

  PMID: 39450982 BACKGROUND

• Kenyon LK, Jones M, Livingstone R, Breaux B, Tsotsoros J, Williams KM. Power mobility for children: a survey study of American and Canadian therapists' perspectives and practices. Dev Med Child Neurol. 2018 Oct;60(10):1018-1025. doi: 10.1111/dmcn.13960. Epub 2018 Jun 28.

  PMID: 29956320 BACKGROUND

• Kenyon LK, Hostnik L, McElroy R, Peterson C, Farris JP. Power Mobility Training Methods for Children: A Systematic Review. Pediatr Phys Ther. 2018 Jan;30(1):2-8. doi: 10.1097/PEP.0000000000000458.

  PMID: 29252826 BACKGROUND

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Bethany M Sloane, PT, DPT, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bethany M Sloane, PT, DPT, PhD

CONTACT

503-494-3232; sloaneb@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 24, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)