N/A
Completed N=24
Early Powered Mobility for Toddlers With Cerebral Palsy Using the Permobil® Explorer Mini and a Modified Ride-On Car
Source: ClinicalTrials.gov NCT04684576 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Change in Child Developmental Outcomes From Baseline to 8 Weeks — 5.8; 0.25; 3.9; 2.8 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Child Developmental Outcomes From Baseline to 8 Weeks |
5.8; 0.25; 3.9; 2.8; 3.9; 2 | — |
| PRIMARY Change in Child Developmental Outcomes From 8 Weeks to 16 Weeks |
1.1; 7.4; -0.1; -0.5; 0.4; 0.9 | — |
| PRIMARY Change in Child Developmental Outcomes From Baseline to 16 Weeks |
6.8; 7.7; 3.8; 2.3; 4.3; 2.9 | — |
| PRIMARY Change in Child Participation and Recreational Activities From Baseline to 8 Weeks |
3.8; -0.9; -0.1; 2; 7.3; 0.3 | — |
| PRIMARY Change in Child Participation and Self-care Activities From 8 Weeks to 16 Weeks |
0.2; 2.9; 0.4; -1.1; 2.8; 0.3 | — |
| PRIMARY Change in Child Participation and Self Care Outcomes From Baseline to 16 Weeks |
4; 2; 0.3; 0.9; 10.1; 0.6 | — |
| SECONDARY Acceptability, Intervention Appropriateness, and Feasibility of The Explorer Mini |
4.5; 4.3; 3.8; 4; 4.1; 4.1 | — |
| SECONDARY Acceptability, Intervention Appropriateness, and Feasibility of the Ride-On Car |
3.4; 4.5; 3.0; 4.6; 3.5; 4.1 | — |
Eligibility Criteria
Inclusion Criteria
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;
- demonstrate proficiency in English. Inclusion criteria will be secured via caregiver report using screening questions.
Exclusion Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04684576). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.