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Compare the Effectiveness of Modified Toy Cars Training With Various Intensity of Postural Combinations: a Randomized Controlled Trial

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ClinicalTrials.gov Identifier: NCT03707405
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hsiang-Han Huang, Chang Gung Memorial Hospital

Brief Summary:

The three purposes of this study are: 1) to determine the feasibility of applying two types of postural combinations for the ride-on car (ROC) use; 2) to compare the effectiveness of ROC training with various intensity of postural combinations on mobility, socialization and energy expenditure in toddlers with disabilities; and 3) to examine the effects of using the different modes of ROC training (different intensity of postural combinations) on the ICF functioning levels, family perceptions and participation. Researchers have recently focused on reducing the limitations of young children with motor disabilities in psychosocial, cognitive, perceptual, and functional development induced by their early lack of independent mobility. Modified ride-on toy cars (ROCs) as a type of PMDs have become an innovative, alternative option to enhance independent mobility and socialization in young children with disabilities. Studies have found that the novel application of modified ROCs in home-based, community-based, school-based or hospital-based environments may enhance independent mobility, motivation, and social function in young children with motor disabilities. The treatment effects of ride-on toy car training with two different postures (i.e., sitting and standing) on mobility and socialization may be different. Our preliminary results of the randomized controlled study showed more positive changes on mobility for the group with sitting posture and more positive changes on social function for the group with standing posture in toddlers with disabilities. Evidence suggested that dose-response effect and energy expenditure of the two postures used for training may result in the observed differences. Therefore, this study is further to examine the effectiveness of ROC training with various intensity of postural combinations on independent mobility, socialization, motivation, physical activity and overall development through low-cost, family-centered approach.

Based on the power analysis from the preliminary results, the investigators will recruit 92 children with disabilities who are between 1 to 3 years old and diagnosed as motor delay (>1.5 sd). They will be randomly assigned to one of the following four groups: ROC-sit group (n=23), ROC-stand group (n=23), ROC training with 45-min sitting and 25-min standing (n=23), and the ROC training group with 25-min sitting and 45-min standing (n=23). The whole study duration will be 24 weeks, including 12-week intervention and 12-week follow-up; the total amount of treatment will be equal for the four groups. 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. All programs will include 120 minutes/per session, 2 sessions/per week. The research team will provide 90-min behavioral videotaping once/per week and let participants wear three accelerometers throughout the 2-hour training. Assessments include mobility, socialization, behavioral coding, family perception and participation. The findings of this study will provide a novel application of ROC training with various intensity of postural combinations on advancing children's mobility, socialization, development and family participation.


Condition or disease Intervention/treatment Phase
Young Children With Motor Disabilities Behavioral: Ride-On Cars Training with Different Postures Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Compare the Effectiveness of Modified Toy Cars Training With Various Intensity of Postural Combinations on Mobility and Socialization in Toddlers With Motor Disabilities: a Randomized Controlled Trial.
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ROC-sit
Ride-On Cars with Sitting Posture (ROC-sit) 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. The natural play session can be divided into two 20-to-25 sessions depending on the participant's condition. Training will concentrate on building the concept of casual-effect on the switch and car motion, practicing goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person) in public spaces (e.g., hallways, convenient stores, garden, museum) and upper limb use in functional tasks with driving, facilitating hand use in functional tasks for exploration and applying motor skills for mobility and socialization in natural play session. All the programs will be discussed by the family, the treating therapist and the research team.
Behavioral: Ride-On Cars Training with Different Postures
All programs will include 120 minutes/per session, 2 sessions/per week. All participants will continue their regular therapy during the whole study. The treatment strategy of ROC training with different postures will be based on the exploratory learning which focuses on providing opportunities to the participants to explore environmental properties with various motor patterns during the intervention.
Other Names:
  • Ride-On Cars with 45-min Sitting and 25-min Standing Postures
  • Ride-On Cars with 25-min Sitting and 45-min Standing Postures
  • Ride-On Cars with Standing Postures

Active Comparator: ROC-sit45 and stand25
Ride-On Cars with 45-min Sitting and 25-min Standing Postures (ROC-sit45 and stand25) The training guidelines and time are the same as the ROC-sit group, except for the posture of driving. The 70-minute driving session begins with a 45-minute driving with sitting posture and then transfers to the standing posture for driving 25 minutes.
Behavioral: Ride-On Cars Training with Different Postures
All programs will include 120 minutes/per session, 2 sessions/per week. All participants will continue their regular therapy during the whole study. The treatment strategy of ROC training with different postures will be based on the exploratory learning which focuses on providing opportunities to the participants to explore environmental properties with various motor patterns during the intervention.
Other Names:
  • Ride-On Cars with 45-min Sitting and 25-min Standing Postures
  • Ride-On Cars with 25-min Sitting and 45-min Standing Postures
  • Ride-On Cars with Standing Postures

Active Comparator: ROC-sit25 and stand45
Ride-On Cars with 25-min Sitting and 45-min Standing Postures (ROC-sit25 and stand45) The training guidelines and time are the same as the ROC-sit group, except for the posture of driving. The 70-minute driving session begins with a 25-minute driving with sitting posture and then transfers to the standing posture for driving 45 minutes.
Behavioral: Ride-On Cars Training with Different Postures
All programs will include 120 minutes/per session, 2 sessions/per week. All participants will continue their regular therapy during the whole study. The treatment strategy of ROC training with different postures will be based on the exploratory learning which focuses on providing opportunities to the participants to explore environmental properties with various motor patterns during the intervention.
Other Names:
  • Ride-On Cars with 45-min Sitting and 25-min Standing Postures
  • Ride-On Cars with 25-min Sitting and 45-min Standing Postures
  • Ride-On Cars with Standing Postures

Active Comparator: ROC-stand
Ride-On Cars with Standing Postures (ROC-stand) The training guidelines and time are the same as the ROC-sit group, except for the posture of driving. The 70-minute standing session can be divided into two 30-minute sessions with 10-minute break, depending on the child's condition with the standing posture.
Behavioral: Ride-On Cars Training with Different Postures
All programs will include 120 minutes/per session, 2 sessions/per week. All participants will continue their regular therapy during the whole study. The treatment strategy of ROC training with different postures will be based on the exploratory learning which focuses on providing opportunities to the participants to explore environmental properties with various motor patterns during the intervention.
Other Names:
  • Ride-On Cars with 45-min Sitting and 25-min Standing Postures
  • Ride-On Cars with 25-min Sitting and 45-min Standing Postures
  • Ride-On Cars with Standing Postures




Primary Outcome Measures :
  1. Change from Baseline Mobility and Social Function at 12 Weeks [ Time Frame: PEDI will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) is a set of tests for children from 8 months to 6 years old. The PEDI-C quantifies self-care, mobility, and social function, and is particularly useful for tracking changes in functional skills. Each domain can be used separately for data analysis. The inter-rater and intra-rater reliabilities of the study reveal excellent agreement of the observations (0.95-0.99), and good concurrent validity with the Functional Independence Measure for Children (Spearman ρ, 0.92-0.99).

  2. Mobility-Driving Performance [ Time Frame: 30 minutes/per week for a total of 12 weeks ]
    Every week during the intervention phase, the 70-minute driving will be recorded and the most active 30 minutes will be selected for coding. The following behaviors will be coded, including driving categories (independent mobility, assisted mobility, caregiver mobility), visual attention to the switch and stopping categories (independent stop, stops with verbal cues, stops with tactile contacts).

  3. Socialization [ Time Frame: 40 minutes/per week for a total of 12 weeks ]
    The behaviors of social interactions are obtained during the most active 30 minutes of driving and the most active 10 minutes of the recorded 20-minute natural play, i.e., the first 20 minutes of natural play. From these videotapes, the frequency and duration of the following will be coded: physical contacts, initiation of contact with others, other initiated contacts, facial expressions, vocalizations/gestures and mutual play events (e.g. sharing an object or a toy).

  4. Change from Posttest Mobility and Social Function at 12 Weeks [ Time Frame: PEDI will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    The Chinese version of Pediatric Evaluation of Disability Inventory (PEDI-C) is a set of tests for children from 8 months to 6 years old. The PEDI-C quantifies self-care, mobility, and social function, and is particularly useful for tracking changes in functional skills. Each domain can be used separately for data analysis. The inter-rater and intra-rater reliabilities of the study reveal excellent agreement of the observations (0.95-0.99), and good concurrent validity with the Functional Independence Measure for Children (Spearman ρ, 0.92-0.99).


Secondary Outcome Measures :
  1. Change from Baseline Sit-to-Stand at 12 Weeks [ Time Frame: This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    5-repetition Sit-to-stand (STS) is a body function test measures the time required to complete five consecutive sit-to-stand cycles as quickly as possible as timed by a stopwatch. Participants will be tested barefoot on a firm mat and the starting position with hip flexed at 90 degrees and knee flexed at 105 degrees. The intraclass correlation coefficients of intra-session reliability and test-retest reliability were 0.95 and 0.99 respectively. The convergent validity was supported by significant correlation with isometric muscle strength, scores of Gross Motor Function Measure, and gait function (r or rho = 0.45-0.78).

  2. Change from Posttest Sit-to-Stand at 12 Weeks [ Time Frame: This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    5-repetition Sit-to-stand (STS) is a body function test measures the time required to complete five consecutive sit-to-stand cycles as quickly as possible as timed by a stopwatch. Participants will be tested barefoot on a firm mat and the starting position with hip flexed at 90 degrees and knee flexed at 105 degrees. The intraclass correlation coefficients of intra-session reliability and test-retest reliability were 0.95 and 0.99 respectively. The convergent validity was supported by significant correlation with isometric muscle strength, scores of Gross Motor Function Measure, and gait function (r or rho = 0.45-0.78).

  3. Change from Baseline Mastery Motivation at 12 Weeks [ Time Frame: This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    The Revised Dimensions of Mastery Questionnaire (DMQ 18)-Chinese version is a body function test and used to measure mastery motivation through caregivers' report. The DMQ has 7 scales: cognitive/object persistence, gross motor persistence, social mastery motivation with adults, social mastery motivation with children/peers, mastery pleasure, negative reactions to challenge in mastery situations, and general competence. A Likert-type scale of 1-5 is used to rate the similarity; lower score indicates lower similarity. The DMQ 18 has four parallel age-related versions for children aged 6 months to 19 years (infant, preschool, school-age rated by adults, and school-age self-report). We utilized the infant version (approximately 6-23 months) and preschool version (approximately 2-6 years) according to the age of the participants. The DMQ 18 shows good validity, internal consistency, and acceptable intra- and inter-rater reliability.

  4. Change from Posttest Mastery Motivation at 12 Weeks [ Time Frame: This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    The Revised Dimensions of Mastery Questionnaire (DMQ 18)-Chinese version is a body function test and used to measure mastery motivation through caregivers' report. The DMQ has 7 scales: cognitive/object persistence, gross motor persistence, social mastery motivation with adults, social mastery motivation with children/peers, mastery pleasure, negative reactions to challenge in mastery situations, and general competence. A Likert-type scale of 1-5 is used to rate the similarity; lower score indicates lower similarity. The DMQ 18 has four parallel age-related versions for children aged 6 months to 19 years (infant, preschool, school-age rated by adults, and school-age self-report). We utilized the infant version (approximately 6-23 months) and preschool version (approximately 2-6 years) according to the age of the participants. The DMQ 18 shows good validity, internal consistency, and acceptable intra- and inter-rater reliability.

  5. Change from Baseline Developmental Abilities at 12 Weeks [ Time Frame: This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    The Bayley Scales of Development (Bayley) is an internationally recognized set of developmental tests that involve play and parental questionnaires. The Bayley has subsets of tests for motor (fine and gross), language (receptive and expressive), and cognitive development, ages from 0-3 years old. The intra- and inter-rater reliability were high for the Bayley III (ICCs=0.88-0.99 and SEMs=0.59-1.60). For discriminative validity, term infants scored significantly higher than preterm infants on the Bayley II and III cognitive (effect size=0.36-0.92 vs. 0.55-0.62), language (effect size=0.20-0.50 vs. 0.22-0.37), and motor scales (effect size=0.48-0.70 vs. 0.48-0.67) over age (all p<0.05).

  6. Change from Posttest Developmental Abilities at 12 Weeks [ Time Frame: This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    The Bayley Scales of Development (Bayley) is an internationally recognized set of developmental tests that involve play and parental questionnaires. The Bayley has subsets of tests for motor (fine and gross), language (receptive and expressive), and cognitive development, ages from 0-3 years old. The intra- and inter-rater reliability were high for the Bayley III (ICCs=0.88-0.99 and SEMs=0.59-1.60). For discriminative validity, term infants scored significantly higher than preterm infants on the Bayley II and III cognitive (effect size=0.36-0.92 vs. 0.55-0.62), language (effect size=0.20-0.50 vs. 0.22-0.37), and motor scales (effect size=0.48-0.70 vs. 0.48-0.67) over age (all p<0.05).

  7. Change from Baseline Home Affordances at 12 Weeks [ Time Frame: This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    The Affordances in the Home Environment for Motor Development (AHEMD) is a reliable and valid assessment to assess the quality and quantity of motor development opportunities in the home during early childhood. Age-related AHEMD questionnaires were developed (3-to-18 months; and 18-to-42 months) and translated into four different languages: English, Chinese, Portuguese, and Spanish. Test-retest reliabilities for AHEMD-Toddler-C were adequate (0.46~0.93). For convergent validity, the correlation coefficients between AHEMD and HOME were 0.44.

  8. Change from Posttest Home Affordances at 12 Weeks [ Time Frame: This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    The Affordances in the Home Environment for Motor Development (AHEMD) is a reliable and valid assessment to assess the quality and quantity of motor development opportunities in the home during early childhood. Age-related AHEMD questionnaires were developed (3-to-18 months; and 18-to-42 months) and translated into four different languages: English, Chinese, Portuguese, and Spanish. Test-retest reliabilities for AHEMD-Toddler-C were adequate (0.46~0.93). For convergent validity, the correlation coefficients between AHEMD and HOME were 0.44.

  9. Change from Baseline Goal Achievements at 12 Weeks [ Time Frame: This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    Goal Attainment Scale (GAS) is a family-centered, criterion-referenced and responsive tool. There are 5 possible outcomes: a score of 0 means the child has attained the goal, whereas scores of -2 and -1 represent lower than expected performance and +1 and +2 are higher than expected performance. Level of satisfaction with goal achievement was also assessed by parents on a weekly basis using a 5-point. Likert scale: 1=very satisfied, 2=somewhat satisfied, 3=neither satisfied nor unsatisfied, 4=somewhat unsatisfied, 5=very unsatisfied. It has excellent inter-rater agreements with inter-class correlations of 0.90 or above. GAS was shown to correlate strongly with other measures that showed change, and it discriminated between lower and higher functional or QOL status.

  10. Change from Posttest Goal Achievements at 12 Weeks [ Time Frame: This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    Goal Attainment Scale (GAS) is a family-centered, criterion-referenced and responsive tool. There are 5 possible outcomes: a score of 0 means the child has attained the goal, whereas scores of -2 and -1 represent lower than expected performance and +1 and +2 are higher than expected performance. Level of satisfaction with goal achievement was also assessed by parents on a weekly basis using a 5-point. Likert scale: 1=very satisfied, 2=somewhat satisfied, 3=neither satisfied nor unsatisfied, 4=somewhat unsatisfied, 5=very unsatisfied. It has excellent inter-rater agreements with inter-class correlations of 0.90 or above. GAS was shown to correlate strongly with other measures that showed change, and it discriminated between lower and higher functional or QOL status.

  11. Change from Baseline Parental Stress at 12 Weeks [ Time Frame: This test will be administered on two occasions: before and after the 12-week intervention (T1 & T2). ]
    Parental Perceptions-Parenting Stress Index (PSI) is a tool that was designed to measure the overall level of parenting stress experienced by parents of children between the ages of 1 month and 12 years. PSI was also translated into Chinese language (PSI-C) and showed very god reliability (from parent : .55-.80). The validity was well established (factorial validity: 41% of variance on child section accounted for by 6 factors; 44% on Parent section by 7 parent factors).

  12. Change from Posttest Parental Perceptions at 12 Weeks [ Time Frame: This test will be administered on two occasions: after the 12-week intervention (T2) and the end of the 12-week follow-up phase (T3). ]
    Parental Perceptions is a set of self-developed questionnaires from the previous studies, which will also be used at T1, T2 and T3 to provide examine parental perceptions on the PMDs use and children's capabilities.

  13. Energy expenditure for Exploration [ Time Frame: 2 hours each week for a total of 12 weeks ]
    Each week the participant wears the accelerometers (ActiGraph®GT9X) on each wrist and right hip during the 2-hour training session, one session/ peer week. The accelerometers code the energy expenditure and physical activity for driving and playing. Combining with the results from the activity logs and videotapes, this data enables us to monitor the energy expenditure, minutes of exercise, postural change, and activity counts for exploration.



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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. motor delays that resulted in motor impairments that prevented independent walking (standard deviation (SD) > 1.5, assessed by the Chinese Child Development Inventory59,60 via a pediatric physician)
  2. can stand independently for two seconds or to tolerate standing with support for 10 minutes
  3. can reach objects 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 the ROC training programs.

Exclusion Criteria:

  1. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707405


Contacts
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Contact: Huang Hsianghan, ScD +886-3-2118800 ext 3821 hsianghan@mail.cgu.edu.tw

Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Hsiang-Han Huang, Assistant Professor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03707405     History of Changes
Other Study ID Numbers: 107WFD2610149
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No