Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car

NCT04684576 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY00011386P2CHD101912
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

The use of powered mobility devices for young children with cerebral palsy (CP) has been gaining traction, with evidence that the use of powered mobility at young ages complements (rather than detracts from) other interventions focused on more traditional mobility skills such as crawling and walking. This study will collect preliminary data (both numeric and opinion/perception data) to investigate device use patterns, caregiver perceptions, and developmental outcomes of children with CP as families are introduced to two early powered mobility interventions: the Permobil® Explorer Mini, and a modified ride-on toy car.

Conditions

Cerebral Palsy

Keywords

At risk for cerebral palsy

Outcome Measures

Primary Outcomes (6)

• Change in Child Developmental Outcomes From Baseline to 8 Weeks

  The Bayley Scales of Infant Development (BSID), 4th Edition is an internationally recognized, norm referenced set of tests designed to assess developmental domains from one month to 42 months of age. This BSID-IV assessment includes Cognitive, Receptive Communication, Expressive Communication, Gross Motor, and Fine Motor subscales. Each subscale has unique score value maximums, but on all subscales, higher scores mean a better outcome. Raw score scales are in increments of 1 and range from: Cognitive (0-81); Receptive Communication (0-42); Expressive Communication (0-37); Gross Motor (0-58); Fine Motor (0-46). Mean changes in Raw Scores are reported for each domain in this summary.

  At baseline, after first 8-week device intervention period

• Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks

  The Bayley Scales of Infant Development (BSID), 4th Edition is an internationally recognized, norm referenced set of tests designed to assess developmental domains from one month to 42 months of age. This BSID-IV assessment includes Cognitive, Receptive Communication, Expressive Communication, Gross Motor, and Fine Motor subscales. Each subscale has unique score value maximums, but on all subscales, higher scores mean a better outcome. Raw score scales are in increments of 1 and range from: Cognitive (0-81); Receptive Communication (0-42); Expressive Communication (0-37); Gross Motor (0-58); Fine Motor (0-46). Mean changes in Raw Scores are reported for each domain in this summary.

  After second 8-week device intervention period.

• Change in Child Developmental Outcomes From Baseline to 16 Weeks

  The Bayley Scales of Infant Development (BSID), 4th Edition is an internationally recognized, norm referenced set of tests designed to assess developmental domains from one month to 42 months of age. This BSID-IV assessment includes Cognitive, Receptive Communication, Expressive Communication, Gross Motor, and Fine Motor subscales. Each subscale has unique score value maximums, but on all subscales, higher scores mean a better outcome. Raw score scales are in increments of 1 and range from: Cognitive (0-81); Receptive Communication (0-42); Expressive Communication (0-37); Gross Motor (0-58); Fine Motor (0-46). Mean changes in Raw Scores are reported for each domain in this summary.

  At baseline, and after the second 8-week device period.

• Change in Child Participation and Recreational Activities From Baseline to 8 Weeks

  Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.

  At baseline, after first 8-week device intervention period.

• Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks

  Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.

  After second 8-week device intervention period.

• Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks

  Child Engagement in Daily Life (CEDL). The CEDL is a caregiver survey tool that assesses participation in family and recreational activities and uses a 5-point Likert scale to assess frequency of participation and enjoyment of participation. The CEDL also assesses participation in self-care behaviors and uses a 5-point Likert scale to assess the degree to which the child participates in the daily self-care activities of feeding, dressing, bathing, and toileting. Scores are reported for the first section, Frequency of Participation, and the third section, Participation in Self-Care, using scaled scores validated with individuals with CP, which range between 0-100. For the remaining section (Enjoyment of Participation), only raw scores are reported, with ranges of 11-55, respectively. Higher or increased scores indicate better outcomes on all scales.

  At baseline, and after the second 8-week device period.

Secondary Outcomes (2)

• Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini

  After first 8-week device intervention period.

• Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car

  After second 8-week device intervention period.

Other Outcomes (5)

• Changes in Caregiver Perceptions of Powered Mobility Devices, Facilitators and Barriers to Use, and Perceptions of Their Child's Developmental Progress Between 8 Weeks and 16 Weeks.

  After second 8-week device intervention period.

• Changes in Caregiver Perceptions of Powered Mobility Devices, Facilitators and Barriers to Use, and Perceptions of Their Child's Developmental Progress Between Baseline and 8 Weeks.

  At baseline, after first 8-week device intervention period.

• Change in Child Participation and Environmental Supportiveness From 8 Weeks to 16 Weeks.

  After second 8-week device intervention period.

Study Arms (2)

Explorer Mini First (AB Arm)

EXPERIMENTAL

Children randomized into this arm will first trial a Permobil Explorer Mini powered mobility device over an 8-week intervention period, then trial a modified ride-on car over a second 8-week intervention period in their home and community environments.

Device: Permobil Explorer Mini; Device: Modified Ride-On Car

Modified Ride On Car First (BA Arm)

ACTIVE COMPARATOR

Children randomized into this arm will first trial a modified ride-on car over an 8-week intervention period, then trial a Permobil Explorer Mini powered mobility device over a second 8-week intervention period in their home and community environments.

Device: Permobil Explorer Mini; Device: Modified Ride-On Car

Interventions

Permobil Explorer Mini DEVICE

The use of powered mobility devices for young children with cerebral palsy is increasingly recommended. The Permobil Explorer Mini is a new pediatric powered wheelchair that has been cleared by the FDA. The Explorer Mini will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child.

Explorer Mini First (AB Arm); Modified Ride On Car First (BA Arm)

Modified Ride-On Car DEVICE

Access to commercial powered mobility devices is often limited by funding or size. Many families use toy ride-on cars for early mobility, which can be easily adapted for safety and accessibility. The modified ride-on car will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child.

Explorer Mini First (AB Arm); Modified Ride On Car First (BA Arm)

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The child will:
• be between 12-36 months old;
• have a medical diagnosis of CP with any level (I-V) of associated motor ability according to the Gross Motor Function Classification System (GMFCS) or be at risk for CP according to birth history and current developmental status;
• be able to attain a seated position with or without support;
• be able to tolerate upright sitting with or without support while moving through space for 30 minutes;
• live in a household where English is spoken proficiently.
• Adults will:
• be 18 years or older and be the legal caregiver for the child participant;

You may not qualify if:

• Child will be excluded if:
• they have not been given a medical diagnosis of CP or are not at risk for CP (per parent report of birth history and current developmental status);
• if they cannot attain a seated position with or without support;
• if they cannot tolerate upright sitting with or without support for 30 minutes;
• Adult caregivers will be excluded if:
• they are not proficient in English (determined per screening process).

Sponsors & Collaborators

• University of Washington: lead
• Oregon State University: collaborator
• Grand Valley State University: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (3)

Grand Valley State University

Grand Rapids, Michigan, 49503, United States

Location

Oregon State University

Corvallis, Oregon, 97330, United States

Location

University of Washington

Seattle, Washington, 98028, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Dr. Heather Feldner, Study PI
• Organization: University of Washington Department of Rehabilitation Medicine

hfeldner@uw.edu

2065433721

Study Officials

• Heather A Feldner, PT, PhD, PCS

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will be completing the developmental assessment scoring will be masked as to which device the child has used and when.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Model Details: A mixed-methods, randomized, counterbalanced 2x2 crossover intervention study. Condition A is 8-weeks of Permobil Explorer Mini Use, and Condition B is 8-weeks of modified ride-on car use.

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 24, 2020
• Study Start: April 15, 2021
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD will be made available 6 months following publication of study results.
• Access Criteria: Study results and summaries will be publicly available at clinicaltrials.gov. For specific IPD, the study PI and co-investigators will review all requests for data sharing. Data will be shared for purposes of secondary analysis, contribution to a population-related database, or similar reasons that are intended to advance the evidence-based provision of family-centered care for children with disabilities.

Locations

US (3)