Using Head-mounted, Eye-tracking to Compare Looking, Manual Exploration and Social Interaction During Active Locomotion
Other study identifiers
Sponsor study identifier
interventional
72
1 country
2
Study Start
August 10, 2022
Actual (reported)Primary Completion
November 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- unknown
- Estimated enrollment
- 72 participants
- Study completion date
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Listed locations
- 1 countries · 2 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
June 28, 2022
Actual (reported)First Posted
July 1, 2022
Actual (reported)Study Start
August 10, 2022
Actual (reported)Primary Completion
November 30, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
- Last Updated
- June 7, 2023
- Status Verified
- June 2023
- Last Update Submitted
- June 5, 2023