Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04468451 |
| Other study ID # |
201802038A3 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 5, 2020 |
| Est. completion date |
July 29, 2022 |
Study information
| Verified date |
February 2024 |
| Source |
Chang Gung Memorial Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Modified ride-on toy cars (ROCs) have been viewed as one Maker Movement and become an
innovative, alternative option to enhance independent mobility and socialization in young
children with disabilities in the recent years. To increase the applicability of this novel
intervention, this study proposes a modified ROC-training program with a less-intensive dose
which may be an effective and a more feasible protocol for clinical therapists and caregivers
to implement.
The three purposes of this study are: 1) to compare the effectiveness of different dosages of
ROC training with a standing posture on social-mobility function, mastery motivation and
physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of
ROC training with a standing posture that is needed to enhance social-mobility function,
mastery motivation and physical activity in toddlers with motor disabilities; and 3) to
examine the effects of different dosages of ROC training with a standing posture on the ICF
functioning levels, family perceptions and participation.
Based on the power analysis from the preliminary results of our RCT study, the investigator
will recruit 45 children with disabilities who are between 1 to 3 years old and diagnosed as
motor delay. They will be randomly assigned to one of the following three groups: a 48-hour
ROC training program with a standing posture (ROC-48) (n=15), a 24-hour ROC training program
with a standing posture (ROC-24) (n=15), and a regular therapy program without additional
training (n=15). The whole study duration will be 24 weeks, including 12-week intervention
and 12-week follow-up. The ROC-48 and ROC-24 programs will include 2 sessions/per week, each
session for 1 hour (ROC-24) or 2 hours (ROC-48) training. All participants will continue
their regular therapy during the whole study. 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 social mobility, mastery motivation, behavioral coding,
body function, family perception and participation. The use of modified toy cars with
different dosages will provide the family and therapists a set of novel, alternative ways to
increase family participation and facilitate development in toddlers with disabilities,
depending on children's and family's needs.
Description:
There is increasing evidence of early power mobility training in recent years, which focuses
on the outcomes of motivation and socialization by using standardized measurements, including
the Dimensions of Mastery Questionnaire (DMQ), the pediatric evaluation of disability
inventory (PEDI) and its' computer adaptive test. These studies showed the use of PMDs might
increase the child's independent mobility and motivation to master interpersonal tasks and
result in positive changes on psychosocial functioning. Previous studies have determined the
feasibility of using a modified ride-on car (ROC) as an alternative, novel option for early
mobility training to improve independent mobility and socialization in children aged younger
than 3 years. Of note is that this technology-focused do-it-yourself (DIY) movement has
provided concrete solutions for children with disabilities, which emphasizes "learning by
doing" and is called "the Maker Movement". Awori and Lee has viewed the process of modifying
the ROCs and applying relevant training as one Maker Movement. Due to the participatory model
of innovation, there are over 60 workshops worldwide that have built approximately 5000
ride-on toy cars. In addition to this universal trend of hands-on practice for health
innovation, the use of ROCs may result in the significant improvements in motivation and
physical activity in young children with motor disabilities.
Kenyon and colleagues reported that pediatric occupational therapists and physical therapists
in Canada and the USA recognized the potential benefits of applying power mobility training
in young children who have mobility impairments. In addition, almost all therapists agreed or
strongly agreed that time and practice were equally as important as a child's abilities when
applying power mobility training. However, 69% of these therapists never or seldom provided
these types of experiences to children in their practice. The amount and type of practice may
play an important role while making the clinical decision. Based on the increased evidence
for children with motor disabilities in the past 10-15 years, researchers have suggested that
the type of treatment may matter less than the amount of treatment (dosage). The idea of
providing an intervention at an amount of greater than standard care has generally been
conceptualized with the terms "intensity or intensive treatment". Up to now, several ROC
studies have suggested intensive dose of therapy may be effective on improving
social-mobility function and mastery motivation. Although the participants were able to
complete the 12-week training, the caregivers felt it may be difficult to implement such
program in their clinical settings. Our previous pilot results have shown that 85% of the
caregivers preferred a 1-hr program than a 2-hr program due to the family resources and
geographical concerns. The current ROC training program typically involves long length (9-12
weeks), high frequency (2 sessions per week) and duration (2 hours per session). However, the
high frequency and duration may not be a feasible protocol for therapists and caregivers. In
addition, there is no study comparing the same type of ROC training at contrasting doses and
therefore could not address the relative effectiveness of different doses of therapy. A
further study with the comparison of different doses of training may help to determine the
optimal program for enhancing social-mobility and psychosocial functions in toddlers with
motor disabilities.
It is important to consider the clients' needs and incorporate the suggestions into the
training protocol based on the evidence. To integrate the caregivers' feedback and increase
the applicability of the ROC training program, the investigator further propose a modified
program of using the ROC with less-intensive doses, i.e., a 1 hour session of 30-to-35-minute
standing-driving for exploration and 25-minute natural play for exploration and skills
training. The investigator assume the less-intensive dose of the ROC training will also have
positive effects on social-mobility function and other ICF levels due to the sufficient
amount of practice suggested by previous evidence (at least 20 to 60 min. moderate to
vigorous intensity/per session, 2 sessions/per week). A 3-group comparison design of
different doses of ROC training with a standing posture may provide us a complete examination
on the topic of dose-response effect on mobility and psychosocial function in toddlers with
disabilities. In this study, the investigator will modify the ride-on toy car (standing
style) for toddlers with disabilities for the use in the public spaces in the university for
12 weeks based on our previous RCT study. This RCT will compare the improvements of
social-mobility function, mastery motivation and physical activity resulting of different
dosages for the ROC use with a standing posture. A control group which receives no ROC
training and only involves regular therapy will be applied as an active control group.
The specific aims of this study are: 1) to compare the effectiveness of different dosages of
ROC training with a standing posture on social-mobility function, mastery motivation and
physical activity in toddlers with motor disabilities; 2) to determine the optimal dosage of
ROC training with a standing posture that is needed to enhance social-mobility function,
mastery motivation and physical activity in toddlers with motor disabilities; and 3) to
examine the effects of different dosages of ROC training with a standing posture on the ICF
functioning levels, family perceptions and participation.
Study Design: A randomized, multiple group pretest-posttest control group design will be
applied.62 Three groups will be involved in this novel project: the dosage of a 48-hour ROC
training program with a standing posture (ROC-48), the dosage of a 24-hour ROC training
program with a standing posture (ROC-24), and a regular therapy program without receiving any
ROC training (control). The participants will be randomly assigned to one of the 3 groups by
using a computer program (Research Randomizer Form www.randomizer.org). The study duration
for each participant is 24 weeks, including 12-week intervention and 12-week follow-up.
Recruitment: The participants will be recruited from self-referrals, health care
practitioners, or the hospitals in Taipei or Taoyuan where toddlers with motor delays are
receiving outpatient rehabilitation. The research team will contact the parent/guardian to
explain study details and provide them the opportunity to ask questions. Parents will receive
a letter detailing the procedure; children of parents/guardians who provide informed consent
will participate in the study.
Procedure: Before the pre-intervention assessments, the research team will modify the car's
seat and acceleration to the hand switch-driven. After modifications, they will receive
pre-intervention measurements, including developmental assessments, behavioral videotaping
and self-developed questionnaires. These assessments will occur on three occasions: before
and after the 12-week intervention (T1 & T2) and the end of the 12-week follow-up phase (T3).
During the 12-week intervention, the social-mobility behaviors for the 2 ROC training groups
will also be videotaped by the research team for 1 hour during one session/per week at the
university. In addition, participants will wear three accelerometers on their wrists and
right hip to monitor the minutes of exercise, postural change, activity counts and energy
expenditure for exploration during one training session/each week for 12 weeks. An activity
log used in the previous studies will also be applied to record the driving and play
duration, driving locations, and the caregiver's feedback on the training program every week.
Intervention: The research team will ask caregivers to identify goals (before intervention),
and measure progress using goal-attainment scaling (GAS) at T1 and T2 time points for the 2
ROC training groups. An independent licensed occupational therapist who will not involve the
administration of assessments will provide the intervention with the caregivers. The training
principles are similar to those applied in our previous studies of ROC training in various
environments. To record the total driving time, locations, and caregivers' feedback regarding
training, an activity log will be used for each week. All groups will continue their regular
therapy from their own therapists throughout the 24-week duration of the study, including
physical therapy, occupational therapy, and speech therapy. The research team do not provide
regular therapy during the study.
On licensed, independent OT will provide the ROC training programs for the two ROC training
groups. The ROC-48 will receive the program in the university for 2 hours/per session, 2
sessions/per week for a total of 12-week intervention. For the ROC-24 group, the participants
will have a 30-to-35-minute car play and a 25-minute natural play and the frequency is 2
sessions/per week for a total of 12 weeks. The training programs for the two ROC training
groups will be based on the ecological and dynamic systems theory. All the programs will be
discussed by the family, the treating therapist and the research team. The program for the
control group will only involve their regular therapy provided by their own clinical
therapists.
Follow-up: This period will involve a 12-week phase following the above treatment programs;
during this time no treatment programs will be delivered to the participants except for their
own regular therapy.
Data Reduction and Analysis: Social-mobility measures will be obtained every week during the
intervention phase, including the simultaneous co-occurrence of self-directed locomotion and
direct adult interaction, and operationalized as number of minutes observed. All data records
will exclude names to provide anonymity of the participant. Two independent coders will code
all the videotapes related to social-mobility and mastery motivation performances. In
addition, they will determine the physical activity for exploration by combining the data
from activity monitors and the videotapes. All the coding criteria of social-mobility and
mastery motivation are established based on the previous studies.
Descriptive statistics including frequency, means, standard deviations, as well as
nonparametric data medians and interquartile ranges will be calculated. Kolmogorov-Smirnov
will be used to examine whether the data follows a normal distribution. To compare the
baseline characteristics of the 3 groups, one-way ANOVA (for data with normal distribution)
and Kruskal-Wallis test (for data with non-normal distribution) will be conducted. If there
is a significant difference among the 3 groups, the specific baseline characteristics will be
analyzed and further determined as the co-variate for the subsequent analysis, e.g., regular
therapy. Data will be analyzed based on an intention-to-treat analysis. A repeated measures
analysis of variance (group [3] × time [3]) will be employed to evaluate the treatment
effects on the primary and secondary outcomes among the 3 groups at T1, T2, and T3, followed
by a post-hoc analysis using Bonferroni test to determine between which groups the
differences occur. SPSS 20.0 (SPSS Inc. Chicago, Illinois, USA) will be used for statistical
analysis. Significance level will be set at p < 0.05.
