Does Dosage Matter: Ride-on Cars to Enhance Social-mobility Function and Motivation in Toddlers With Motor Disabilities

NCT04468451 | Completed

• 1 other identifier: 201802038A3
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Modified ride-on toy cars (ROCs) have been viewed as one Maker Movement and become an innovative, alternative option to enhance independent mobility and socialization in young children with disabilities in the recent years. To increase the applicability of this novel intervention, this study proposes a modified ROC-training program with a less-intensive dose which may be an effective and a more feasible protocol for clinical therapists and caregivers to implement. The three purposes of this study are: 1) to compare the effectiveness of different dosages of ROC training with a standing posture on social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of ROC training with a standing posture that is needed to enhance social-mobility function, mastery motivation and physical activity in toddlers with motor disabilities; and 3) to examine the effects of different dosages of ROC training with a standing posture on the ICF functioning levels, family perceptions and participation. Based on the power analysis from the preliminary results of our RCT study, the investigator will recruit 45 children with disabilities who are between 1 to 3 years old and diagnosed as motor delay. They will be randomly assigned to one of the following three groups: a 48-hour ROC training program with a standing posture (ROC-48) (n=15), a 24-hour ROC training program with a standing posture (ROC-24) (n=15), and a regular therapy program without additional training (n=15). The whole study duration will be 24 weeks, including 12-week intervention and 12-week follow-up. The ROC-48 and ROC-24 programs will include 2 sessions/per week, each session for 1 hour (ROC-24) or 2 hours (ROC-48) training. All 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. Assessments include social mobility, mastery motivation, behavioral coding, body function, family perception and participation. The use of modified toy cars with different dosages will provide the family and therapists a set of novel, alternative ways to increase family participation and facilitate development in toddlers with disabilities, depending on children's and family's needs.

Conditions

Mobility Limitation

Keywords

toddlers with disabilities; modified ride-on cars; social-mobility; mastery motivation; physical activity; family participation

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)

  EDI 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-Mobility Performance

  Every week during the intervention phase, the first 1 hour session will be recorded. The social-mobility behavior is defined as the simultaneous co-occurrence of self-directed locomotion and direct adult interaction, and operationalized as number of minutes observed.

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

Secondary Outcomes (8)

• 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.

• 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 Participation level at 12 weeks and 24 weeks as assessed by The Goal Attainment Scale (GAS)

  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 (3)

ROC-48 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 motor delay. Parents/caregivers and the occupational therapist will be responsible for ride-on car with a standing posture training. The dosage will be 48 hours for a total of 12-week intervention.

Behavioral: A 48-hour ROC training program with a standing posture

ROC-24 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 motor delay. Parents/caregivers and the occupational therapist will be responsible for ride-on car with a standing posture training. The dosage will be 24 hours for a total of 12-week intervention.

Behavioral: A 24-hour ROC training program with a standing posture

Control 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 motor delay. The participant's clinical occupational therapist will be responsible for the regular therapy. The dosage will be their regular dosage for a total of 12-week intervention.

Behavioral: A regular therapy program without receiving any ROC training

Interventions

A 48-hour ROC training program 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-48 group

A 24-hour ROC training program with a standing posture BEHAVIORAL

The 1-hour training session is composed of a 30-to-35-minute car play and a 25-minute natural play. 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-24 group

A regular therapy program without receiving any ROC training BEHAVIORAL

The regular therapy group will be an active control group without receiving any additional training. The training dosage will be their own therapy, including occupational, physical and speech therapy. They will continue their regular therapy, including physical, occupational and speech therapy. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks.

Control 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) 2. can stand independently for two seconds or to tolerate standing with support for 10 minutes 3. can reach for objects/toys with either one or two hands 4. the height is between 69 to 103 cm and the weight is between 7-18 kg 5. 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 2. the height is not between 69 to 103 cm and the weight is not between 7 to 18 kg 3. parents/caregivers are not able to make a time commitment for the training phase

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung University

Taoyuan, Taoyuan County, 33302, Taiwan

Location

MeSH Terms

Conditions

Mobility Limitation; Motor Activity

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Hsiang-Han 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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 13, 2020
• Study Start: August 5, 2020
• Primary Completion: May 5, 2022
• Study Completion: July 29, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

TW (1)