NCT04467866

A Randomized Controlled Trial of ride-on Car Training and Locomotor Experience in Toddlers With Different Motor Delays

Completed NA Last updated 28 August 2023

What this trial tests

NA trial testing A Ride-on Car with a Standing Posture in Mobility Limitation in 13 participants. Completed in 31 December 2022.

Timeline

5 August 2020

Primary endpoint
31 August 2022

31 December 2022

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	13
Start date	5 August 2020
Primary completion	31 August 2022
Estimated completion	31 December 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• A Ride-on Car with a Standing Posture
• Regular Therapy Program

Conditions studied

• Mobility Limitation — all drugs for Mobility Limitation →

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 12 Months to 36 Months, any sex, with Mobility Limitation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The three purposes of this study are: 1) to compare the effectiveness of the ROC-Stand training on mobility, psychosocial function and social looking with conventional therapy in toddlers with mild and moderate motor disabilities, 2) to compare the effectiveness of ROC-Stand training on body function level and environmental factors with conventional therapy in toddlers with mild and moderate motor disabilities, according to International Classification of Functioning, Disability and Health (ICF) levels, and 3) to determine the effects of ROC-Stand training on the relationship among social looking, caregiver-child interactions and mastery motivation in toddlers with mild and moderate motor disabilities.

Based on the power analysis from the preliminary results of the pilot study, the investigator will recruit 92 toddlers with motor delays and further assign them to either mild or moderate motor delays group. The participants in each group will be randomly assigned to either the ROC-Stand training program or conventional therapy(Control) program, resulting the following four training groups: the ROC-Stand(Mild) group (n=23), the ROC-Stand(Mod) group (n=23), Control(Mild) group (n=23), and Control(Mod) group (n=23). The whole study duration will be 24 weeks, including a 12-week intervention and a 12-week follow-up. All programs will include 120 minutes/per session, 2 sessions/per week. Participants will continue their regular therapy during the whole study. Standardized assessments are provided for a total three times, including the time before and after the intervention and in the end of the follow-up phase. The head-mounted cameras worn by the participants and caregivers will record the social looking and interaction behaviors for one 2-hour session/per week during intervention. Participants will also wear three accelerometers throughout the 2-hour training. Assessments include mobility, socialization, behavioral coding, body function, family perception and participation. The findings of this study will provide us some optimal, alternative ways to enhance locomotor experience depending on each child's and family's needs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.