Using Head-mounted, Eye-tracking to Compare Looking, Manual Exploration and Social Interaction During Active Locomotion in Toddlers With Mild, Moderate and Severe Motor Delays: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Visual Fixations during Obstacle Encounter
研究概览
简要总结
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.
详细描述
Although environmental and task modifications are powerful methods used to affect function in rehabilitation and frequently used by the therapists, these modifications are typically introduced using a trial and error approach. A better understanding of the fits between the child and the environment may help therapists develop a more structured approach to manipulating environmental and task characteristics in order to enhance the emergent actions of children. The important factors required to achieve positive effects of ride-on car (ROC) training include the"fit"between a child's characteristics, the modified ROC, and the physical and social contexts.
Based on the findings of previous randomized controlled trials (RCTs) (NCT03707405), children with mild motor delay may gain the most from using the ROC-Stand style for 70 minutes (ROC-Stand) while those with moderate motor delay may gain the most with a 25-minute standing posture and a 45-minute sitting posture (ROC-Stand25). Children with severe motor delay may benefit more from the ROC training in a sitting posture (ROC-Sit), which may provide moderate challenges as an optimal mobility training program. Thus, the heterogeneity of the participants regarding severity level of motor delays and environmental considerations may be the factors contributing to the different treatment effects.
A new technical challenge occurs to record and capture young children's visual and haptic exploration. Infants cannot attend to the entire visual field captured by the action camera and their attention constantly shifts between areas of the visual field. It is difficult to differentiate what the targets the child actually fixates at or interacts with. To allow the direct observation of infants' spontaneous eye movements during self-initiated locomotion, Dr. Adolph have used a wireless, head-mounted eye-tracker (Positive Science, LLC) which could measure infants' visual behaviors during free, unfettered locomotion. This novel methodology includes a lightweight and comfortable headgear, transmitter, and battery pack which can record infants' eye gaze. The analysis can focus on where infants look during self-initiated locomotion, object exploration and in response to caregivers' vocalizations. The combination of the ROC training with this head-mounted eye-tracker will allow us to further track what visual and haptic information is obtained during the early PMD use. It is helpful for understanding the influences of environmental factors on psychosocial function in toddlers with motor delays.
To provide a full investigation of the effectiveness of optimal mobility training, this study proposes to compare the effects on toddlers with mild, moderate and severe motor delays. Additionally, a wireless, head-mounted eye-tracker will be applied as the novel method to analyze children's looking, manual behaviors and social interaction during the training phase.
The specific aims 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 level 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •69 to 103 cm height and 7 to 18 kg weight
- •parents agreeing to provide consent for their child's participation in the training program
排除标准
- •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.
结局指标
主要结局
Visual Fixations during Obstacle Encounter
时间窗: 40-minute each week during the intervention phase
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.
Body Looking, Toy and Environment Looking
时间窗: 40-minute each week during the intervention phase
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.
Fixations to Destinations
时间窗: 40-minute each week during the intervention phase
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.
Visual Fixations during Manual Encounter
时间窗: 40-minute each week during the intervention phase
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.
Social Encounter
时间窗: 40-minute each week during the intervention phase
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.
Face Looking
时间窗: 40-minute each week during the intervention phase
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.
次要结局
- The Parenting Stress Index Short Form (PSI/SF)(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 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).)
- 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).)
- Activity Log(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).)
- Goal Attainment Scale (GAS)(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).)
- Parental Perceptions(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).)
- The Chinese version of the Affordance in the Home Environment for Motor Development - Toddler version (AHEMD-Toddler-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).)
研究者
Hsiang-Han Huang
Associate Professor
Chang Gung Memorial Hospital