Using Head-mounted, Eye-tracking to Compare Looking, Manual Exploration and Social Interaction During Active Locomotion

NCT05441137 | Unknown

• 1 other identifier: 111WFD2610060
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

The three purposes of this study are: 1) to determine the feasibility of using a head-mounted eye-tracker and examine the effects of the optimal mobility training on increasing visual and manual exploration in toddlers with different severity levels of motor delays, 2) to compare the effectiveness of providing optimal mobility training on outcomes across the ICF framework in toddlers with mild, moderate and severe motor delays, and 3) to determine the effects of optimal mobility training on the relationship among looking and manual actions, caregiver-child interactions and mastery motivation in toddlers with mild, moderate and severe motor delays. Based on the power analysis from the preliminary results of the pilot study, we will recruit 72 toddlers with motor delays and further assign them to the mild, moderate or severe motor delays group. The participants in each group will be randomly assigned to either the ROC training program or conventional therapy (Control) program, resulting the following six training groups: the ROCStand(Mild) group (n=12), the ROC-Stand25(Mod) group (n=12), the ROCSit(Sev) group (n=12), Control(Mild) group (n=12), Control(Mod) group (n=12), and Control(Sev) group (n=12). 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. The head-mounted cameras worn by the participants and caregivers will record the visual and manual behaviors for 40 minutes/per week during intervention. 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 body function, mobility, psychosocial function, family perception and participation. The findings of this study will provide guidelines for arranging the training environment depending on each child's and family's needs.

Conditions

Young Children With Motor Disabilities

Outcome Measures

Primary Outcomes (6)

• Face Looking

  The frequency (number of times) and duration (in seconds) that the child looks at the interacting person (social partner). Looking at the face will be scored any time if the circular cursor contains any part of the social partner's face, between the chin and the hairline; hair and the back of the head are not included. Additionally, we assume participants' gaze to be directed at the social partner's face if both the gaze location and the face are above the boundary of the video frame.

  40-minute each week during the intervention phase

• Body Looking, Toy and Environment Looking

  The frequency (number of times) and duration (in seconds) that the child looks at the person's body or toy. Looking at bodies will be scored when the circular cursor intersects with any part of the body, excluding the face. In addition, body looking is also scored if the gaze cursor falls on a toy held in the hands of the social partner. Body looking includes all person-directed looking except face looking. Looking at the toys is scored any time when the circular cursor contains any part of the toys and does not contain the partner's face. The same video can be counted as both toy and body looking if looking is directed at a toy held by the caregiver. Environment looking includes all looking except face, body and toy looking. Looking at the environment is scored any time when the circular cursor contains any part of an object or physical structure of the environment, e.g., wall, door, floor, box…etc.

  40-minute each week during the intervention phase

• Visual Fixations during Obstacle Encounter

  The frequency (number of times) and duration (in seconds) of fixations will be coded. Obstacle encounter refers to the child's PMD or leading limb contacts the new surfaces, e.g., up, down or over a surface of a different height or texture. Coders will identify fixations in the 5 seconds prior to obstacle encounter. An obstacle fixation is counted if the gaze crosshair rests stably on the obstacle for 3 or more consecutive frames (100ms). We will score any fixation within a car's or step's length of where children actually drive or place their limbs. If the child fixates the surface multiple times in the 5 seconds period, we will only count the fixation occurs closest moment of the encounter. Fixation initiation will be scored from the start of the fixation until the moment of the encounter. Fixation termination will be scored from the last frame of that fixation until the moment of the encounter.

  40-minute each week during the intervention phase

• Visual Fixations during Manual Encounter

  The frequency (number of times) and duration (in seconds) will be coded. Manual encounter refers to the child's hand contacts the objects or toys. We will only count the first object touch during repetitive bouts during which touches of the same object occur within 2 seconds of each other. For each manual encounter, we will score object fixations in the 5 seconds prior to contacting the object with the hand. Because objects may be in motion before the child reaches for them, we will include both fixations and smooth pursuit of objects, provided gaze is stable on the target for 100 ms. We will only count the last fixation before the manual encounter in the event of multiple fixations or smooth pursuits.

  40-minute each week during the intervention phase

• Social Encounter

  The frequency (number of times) and duration (in seconds) will be coded. Social encounter refers to the social partner's any speech sound directs toward the child separated by at least 0.5 seconds from the previous vocalization. We will code each time that the child fixates his/her social partner, including face, hands, or body.

  40-minute each week during the intervention phase

• Fixations to Destinations

  The frequency (number of times) and duration will be coded. Fixations will be counted if the destination is within the 4°gaze indicator for three consecutive frames (\~90 ms). Locomotion ending at destinations are destination directed if the child fixates the destination during the period between the last destination and the current locomotion initiation. Discovery locomotion occurs when the child travels to a new destination that is fixated after the child is already in motion, or if the child stops moving near a destination that is never fixated.

  40-minute each week during the intervention phase

Secondary Outcomes (10)

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

  The test will be administered on three occasions: before and after the 12-week intervention (T1 & T2) and the end of the 12-week follow up phase (T3).

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

  The test will be administered on three occasions: before and after the 12-week intervention (T1 & T2) and the end of the 12-week follow up phase (T3).

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

  The test will be administered on three occasions: before and after the 12-week intervention (T1 & T2) and the end of the 12-week follow up phase (T3).

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

  The test will be administered on three occasions: before and after the 12-week intervention (T1 & T2) and the end of the 12-week follow up phase (T3).

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

  The test will be administered on three occasions: before and after the 12-week intervention (T1 & T2) and the end of the 12-week follow up phase (T3).

Study Arms (6)

A ROC with a Standing Posture for Toddlers with Mild Motor Delays (ROC-Stand(Mild))

ACTIVE COMPARATOR

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. Each week the research team will help the participant wear a wireless, head-mounted eye-tracker (46g) for recording the first 20-minute of both 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 40-to-50-minute natural play session, with a 10-mintue break if necessary according to the previous ROC-related studies. The natural play session can be divided into two 20-to-25-minute sessions depending on the participant's condition. The head-mounted cameras worn by the participants and caregivers will record the visual and manual behaviors for 40 minutes/per week during intervention. All programs will be discussed by the family, the treating therapist and the research team.

Behavioral: Ride-On Cars Training with Different Postures

A ROC with a 25-minute Standing Posture for Children with Moderate Motor Delays (ROC-Stand25(Mod))

ACTIVE COMPARATOR

The training guidelines and time are the same as the ROC-Stand(Mild) group, except for the participant's severity level of motor delay and using a 25-minute standing and 45-mnute sitting posture for driving. The participants will also wear the head-mounted eye tracker in one training session every week.

Behavioral: Ride-On Cars Training with Different Postures

A ROC with a Sitting Posture for Children with Severe Motor Delays (ROC-Sit(Sev))

ACTIVE COMPARATOR

The training guidelines and time are the same as the ROC-Stand(Mild) group, except for the participant's severity level of motor delay and using a sitting posture for driving. The participants will wear the head-mounted eye tracker in one training session every week.

Behavioral: Ride-On Cars Training with Different Postures

Conventional Therapy for Children with Mild Motor Delays (Control(Mild))

PLACEBO COMPARATOR

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. Each participant will have the opportunity to walk on certain 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 in one training session every week.

Behavioral: Conventional Therapy

Conventional Therapy for Toddlers with Moderate Motor Delays (Control(Mod))

PLACEBO COMPARATOR

The training guidelines and time are the same as the Control(Mild) group, except for the participant's severity level of motor delay. The participants will wear the head-mounted eye-tracker in one training session every week.

Behavioral: Conventional Therapy

Conventional Therapy for Toddlers with Severe Motor Delays (Control(Sev))

PLACEBO COMPARATOR

The training guidelines and time are the same as the Control(Mild) group, except for the participant's severity level of motor delay. The participants and caregivers will also head-mounted eye-tracker in one training session every week.

Behavioral: Conventional Therapy

Interventions

Ride-On Cars Training with Different Postures 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: Ride-On Cars with Standing Postures, Ride-On Cars with 25-min Sitting and 45-min Standing Postures, Ride-On Cars with Sitting Postures

A ROC with a 25-minute Standing Posture for Children with Moderate Motor Delays (ROC-Stand25(Mod)); A ROC with a Sitting Posture for Children with Severe Motor Delays (ROC-Sit(Sev)); A ROC with a Standing Posture for Toddlers with Mild Motor Delays (ROC-Stand(Mild))

Conventional Therapy BEHAVIORAL

The other independent OT will be responsible for providing conventional therapy 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 mobility, socialization and upper limb use in functional tasks.

Conventional Therapy for Children with Mild Motor Delays (Control(Mild)); Conventional Therapy for Toddlers with Moderate Motor Delays (Control(Mod)); Conventional Therapy for Toddlers with Severe Motor Delays (Control(Sev))

Eligibility Criteria

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

You may qualify if:

• motor delays that resulted in motor impairments preventing independent walking (standard deviation \[SD\] \<-1.5, 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 were unable to make the time commitment for the program and children with severe emotional disorders resulting in strong reactions and causing possible harms.

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

MeSH Terms

Interventions

Sitting Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: June 28, 2022
• First Posted: July 1, 2022
• Study Start: August 10, 2022
• Primary Completion: November 30, 2024
• Study Completion: July 31, 2025
• Last Updated: June 7, 2023

Record last verified: 2023-06

Locations

TW (2)