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

NCT04467866 | Completed

• 1 other identifier: MOST 109-2314-B-182-032 -
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mobility Limitation

Keywords

toddlers with motor delays; modified ride-on cars; severity level; locomotor experience; mobility; psychosocial function

Outcome Measures

Primary Outcomes (2)

• Change from baseline in General Mobility and Social Development at 12 weeks and 24 weeks as assessed by the Cinese version of Pediatric Evaluation of Disability Inventory (PEDI)

  PEDI is a set of tests for children from 8 months to 6 years old. The PEDI quantified self-care, mobility, and social functions. The PEDI is especially useful for tracking changes in functional skills.

  Assessment will occur 3 times during the whole study, including the first and last week of the 12-week intervention, and the end of the 12-week follow-up phase

• Social Looking and Interactions

  The behaviors of social looking and interactions are recorded from the head-mounted action cameras.The frequency and duration of the following will be coded: face looking, body looking, toy and environment looking, participants' and caregivers' vocalizations, child-initiated and caregiver-initiated vocalizations/gestures, concurrent/overlapping vocalizations, conversational units and visual scan.

  The socialization behaviors will be followed for the duration of implementing the intervention phase, an expected average of 12 weeks.

Secondary Outcomes (8)

• Physical Activity for Exploration as assessed by the number of counts recorded from the accelerators wearing on both wrists and the hip

  The socialization behaviors will be followed for the duration of implementing the intervention phase, an expected average of 12 weeks.

• Change from baseline in General Development at 12 weeks and 24 weeks as assessed by The Bayley Scales of Development

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in General Development at 12 weeks and 24 weeks as assessed by The Affordances in the Home Environment for Motor Development (AHEMD)

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in Body Function/Structure at 12 weeks and 24 weeks as assessed by 5-repetition Sit-to-stand (STS) test

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

• Change from baseline in Body Function/Structure at 12 weeks and 24 weeks as assessed by Revised Dimensions of Mastery Questionnaire (DMQ 18) - Chinese version

  It will be administered a total of 3 times during the whole study, including the beginning and end of the 12-week intervention, and the end of the 12-week follow up.

Study Arms (4)

ROC-Stand(Mild) group

EXPERIMENTAL

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as mild motor delay. Parents/caregivers and occupational therapists will be responsible for ride-on car with standing posture training.

Behavioral: A Ride-on Car with a Standing Posture

ROC-Stand(Mod) group

EXPERIMENTAL

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as moderate motor delay. Parents/caregivers and occupational therapists will be responsible for ride-on car with standing posture training.

Behavioral: A Ride-on Car with a Standing Posture

Control(Mild) group

ACTIVE COMPARATOR

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as mild motor delay. The other occupational therapist will be responsible for regular therapy.

Behavioral: Regular Therapy Program

Control(Mod) group

ACTIVE COMPARATOR

The participant's performance is indicative of the extent to which early power mobility training is feasible for 1 to 3 years old and diagnosed as moderate motor delay. The other occupational therapist will be responsible for regular therapy.

Behavioral: Regular Therapy Program

Interventions

A Ride-on Car with a Standing Posture BEHAVIORAL

The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.

ROC-Stand(Mild) group; ROC-Stand(Mod) group

Regular Therapy Program BEHAVIORAL

The goals are to improve certain motor skills or psychosocial skills based on each participant's current developmental stage. The general propose of the training is to facilitate the developmental scales and improve mobility, socialization and upper limb use in functional tasks. Each participant will have the opportunity to walk on the hallway/public space and interact with the therapist and caregivers depending on his/her motor abilities.

Control(Mild) group; Control(Mod) group

Eligibility Criteria

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

You may qualify if:

• motor delays that resulted in motor impairments that prevented independent walking (standard deviation (SD) \< -1.5, assessed by the Chinese Child Development Inventory (CCDI) via a pediatric physician)
• can sit independently without support for 3 seconds
• can stand independently for two seconds or to tolerate standing with support for 10 minutes
• can reach for objects/toys with either one or two hands
• the height is between 69 to 103 cm and the weight is between 7-18 kg
• parents are able to provide consent for their child's participation in training programs

You may not qualify if:

• children with severe sensory impairments such as blindness, deafness
• the height is not between 69 to 103 cm and the weight is not between 7 to 18 kg
• parents/caregivers are not able to make a time commitment for the training phase

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Chang Gung University

Taoyuan, Taoyuan County, 33302, Taiwan

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• HsiangHan Huang, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: August 5, 2020
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: August 28, 2023

Record last verified: 2022-03

Locations

TW (1)