Long-term Effectiveness of Different Dosage Parameters of Early Powered Mobility Training for Toddlers With Motor Delays

NCT06000631 | Recruiting

• 1 other identifier: 112WFD2610076
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The three purposes of this study are: 1) to compare the effects on looking behaviors, visual fixation and social interaction through the use of a head- mounted, eye-tracker in toddlers with motor disabilities after receiving different intensity levels of ROC-Stand training; 2) to compare short-term and long-term outcomes in terms of body function, activity and participation across the ICF framework, family perceptions and participation; and 3) to identify factors that predict individual differences in outcomes for toddlers with motor delays with the two dosing protocols. Based on the power analysis from the pilot study, the investigators will recruit 30 toddlers with motor delays and further randomly assign the participants to the 3 groups with the same total amount of 48-hour training, including 2 ROC-Stand groups and 1 conventional therapy group, i.e., an intensity level of 2-hour session of ROC-Stand training (ROC-Stand(2-hr)) (n=10), an intensity level of 1-hour session of ROC-Stand training (ROC-Stand(1-hr)) (n=10), and an intensity level of 1-hour session of conventional therapy (Control(1-hr)) (n=10). The training frequency for the 3 groups is 2 sessions/per week. The whole study duration will be 1 year. The head-mounted cameras worn by the participants will record the visual and interactive behaviors for 20 minutes/per week during intervention. Standardized assessments are provided for a total 4 times, including the time before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4). Assessments include body function, activity and participation across the ICF domains, family perception and participation. The findings of this study will provide guidelines for adjusting the dosage parameters of early powered mobility depending on each child's and family's needs.

Conditions

Young Children With Motor Disabilities

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Frequency of Looking and Fixation Behaviors at 24 weeks

  Every week during the intervention phase, the first 10-minute of driving session and the first 10-minute of natural play session will be recorded from the eye-tracker for coding. The following behaviors will be coded, including looking behaviors (face, body, toy, environment and object looking) and fixation behaviors during different encounters (social, obstacle, manual and destinations).

  20 minutes/per week from the first week until the final week of intervention, up to 24 weeks

Secondary Outcomes (10)

• The Bayley Scales of Infant and Toddler Development-Third Edition (Bayley-III)

  The test will be administered on four occasions: before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4)

• Infant/Toddler Sensory Profile - Chinese version (ITSP-C)

  The test will be administered on four occasions: before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4)

• Peabody Developmental Motor Scales - Second edition (PDMS-2)

  The test will be administered on four occasions: before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4)

• The Revised Dimensions of Mastery Questionnaire (DMQ 18) - Chinese version

  The test will be administered on four occasions: before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4)

• The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C)

  The test will be administered on four occasions: before training (T1), 3 months following initiation of training (T2), 6 months following initiation of training (T3), and the end of a year following initiation of training (T4)

Study Arms (3)

2-hour session of ROC-Stand training for a total of 48 hours (ROC-Stand(2-hr))

ACTIVE COMPARATOR

A licensed, independent therapist and caregivers will provide the training program in the public space in the university for 2 hours/per session, 2 sessions/per week for a total of 12-week intervention based on ecological and dynamic systems theories. Each week the participant will wear a light-weight, head-mounted eye-tracker for recording the first 10-minute of driving and natural play sessions in a 2-hour training session. The 2-hour training session is composed of a 70-minute driving session and a 50-minute natural play session. Training will concentrate on building the concept of casual-effect on the control system and car motion, practicing goal-oriented driving in certain public spaces, upper limb use in functional tasks for exploration in driving sessions, and applying various motor skills for mobility and socialization in natural play sessions. The program will be discussed by the family and the treating therapist.

Behavioral: Ride-On Car Training in a standing posture with a 2-hour session

1-hour session of ROC-Stand training for a total of 48 hours (ROC-Stand(1-hr))

ACTIVE COMPARATOR

The same therapist for the ROC-Stand(2-hr) group will be responsible for the program. The training frequency and guidelines are the same as the ROC-Stand(2-hr) group, except for the training intensity of 1-hour per session and intervention duration for 24 weeks. Each 1-hour session will include a 35-minute car play and a 25-minute natural play. The participants will also wear the head-mounted eye tracker in one training session for recording 20 minutes (the first 10-minute of driving and the first 10-minute of natural play) every week.

Behavioral: Ride-On Car Training in a standing posture with a 1-hour session

1-hour session of conventional therapy for a total of 48 hours (Control(1-hr))

ACTIVE COMPARATOR

Another licensed, independent therapist will provide the training program to the Control(1-hr) group for 1 hours/per session, 2 sessions/per week for a total of 24-week intervention. The conventional therapy provided in the Control(1-hr) group is based on the developmental and motor learning theories. 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 certain mobility, socialization and upper limb use in functional tasks. Each participant will have the opportunity to walk on the same public space as the ROC training groups and interact with the therapist and caregivers depending on his/her motor abilities. The participants will also wear the head-mounted eye-tracker for the first 20 minutes in one training session every week.

Behavioral: Conventional Therapy with a 1-hour session

Interventions

Ride-On Car Training in a standing posture with a 2-hour session BEHAVIORAL

A licensed, independent therapist and caregivers will provide the training program in the public space in the university for a total of 12-week intervention based on ecological and dynamic systems theories. Training will concentrate on building the concept of casual effect on the control system and car motion, practicing goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person, play hide-and-seek) in certain public spaces, including hallways, convenient stores, garden, museum and upper limb use in functional tasks with driving, facilitating hand use in functional tasks for exploration and applying various motor skills for mobility and socialization in natural play session. Every week's treatment program will preplanned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Participants will continue their regular therapy during the whole study.

Also known as: ROC-Stand(2-hr)

2-hour session of ROC-Stand training for a total of 48 hours (ROC-Stand(2-hr))

Ride-On Car Training in a standing posture with a 1-hour session BEHAVIORAL

A licensed, independent therapist and caregivers will provide the training program in the public space in the university for a total of 24-week intervention based on ecological and dynamic systems theories. Training will concentrate on building the concept of casual effect on the control system and car motion, practicing goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person, play hide-and-seek) in certain public spaces, including hallways, convenient stores, garden, museum and upper limb use in functional tasks with driving, facilitating hand use in functional tasks for exploration and applying various motor skills for mobility and socialization in natural play session. Every week's treatment program will preplanned and adjusted by the therapist and the caregivers through discussion and clinical observation of the participant's performance in the previous session. Participants will continue their regular therapy during the whole study.

Also known as: ROC-Stand(1-hr)

1-hour session of ROC-Stand training for a total of 48 hours (ROC-Stand(1-hr))

Conventional Therapy with a 1-hour session BEHAVIORAL

The other independent OT will be responsible for providing conventional therapy in the same location as the ROC-Stand training for a total of 24-week intervention based on the developmental and motor learning theories. The goals are to improve certain motor skills or psychosocial skills based on each participant's current developmental stage. The general purpose of the training is to facilitate the developmental scales and improve mobility, socialization, and upper limb use in functional tasks.

Also known as: Control(1-hr)

1-hour session of conventional therapy for a total of 48 hours (Control(1-hr))

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 1-3 years old
• motor delays that resulted in motor delays that prevented independent walking (\> 1.5 standard deviation \[SD\] below the mean, assessed by the Chinese Child Development Inventory via a pediatric physician)
• being able to stand independently for two seconds or tolerate standing with support for 10 minutes
• being able to reach objects with either one or both hands
• to 103 cm height and 7 to 18 kg weight
• parents agreeing to provide consent for their child's participation in the training program

You may not qualify if:

• children with severe sensory impairments (including blindness or deafness)
• exceeding the height or weight criteria
• parents/guardians who are unable to make the time commitment for the program
• children with severe emotional reactions which may result in harm

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (2)

Chang Gung University

Taoyuan, Taoyuan County, 33302, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan, Taoyuan County, 33302, Taiwan

RECRUITING

Study Officials

• Hsiang-Han Huang, ScD

  Chang Gung University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsiang-Han Huang, ScD

CONTACT

+886-3-2118800; hsianghan@mail.cgu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 21, 2023
• Study Start: August 30, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 11, 2024

Record last verified: 2024-01

Locations

TW (2)