Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04467866 |
Other study ID # |
MOST 109-2314-B-182-032 - |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 5, 2020 |
Est. completion date |
December 31, 2022 |
Study information
Verified date |
March 2022 |
Source |
Chang Gung Memorial Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The three purposes of this study are: 1) to compare the effectiveness of the ROC-Stand
training on mobility, psychosocial function and social looking with conventional therapy in
toddlers with mild and moderate motor disabilities, 2) to compare the effectiveness of
ROC-Stand training on body function level and environmental factors with conventional therapy
in toddlers with mild and moderate motor disabilities, according to International
Classification of Functioning, Disability and Health (ICF) levels, and 3) to determine the
effects of ROC-Stand training on the relationship among social looking, caregiver-child
interactions and mastery motivation in toddlers with mild and moderate motor disabilities.
Based on the power analysis from the preliminary results of the pilot study, the investigator
will recruit 92 toddlers with motor delays and further assign them to either mild or moderate
motor delays group. The participants in each group will be randomly assigned to either the
ROC-Stand training program or conventional therapy(Control) program, resulting the following
four training groups: the ROC-Stand(Mild) group (n=23), the ROC-Stand(Mod) group (n=23),
Control(Mild) group (n=23), and Control(Mod) group (n=23). 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. 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. The head-mounted cameras worn by the participants and caregivers will record the
social looking and interaction behaviors for one 2-hour session/per week during intervention.
Participants will also wear three accelerometers throughout the 2-hour training. Assessments
include mobility, socialization, behavioral coding, body function, family perception and
participation. The findings of this study will provide us some optimal, alternative ways to
enhance locomotor experience depending on each child's and family's needs.
Description:
Locomotor posture as upright can increase infants' visual availability of destinations and
induce their motivation to interact and explore with environment. Using a modified ride-on
car (ROC) with a standing posture (ROC-Stand) may result in the similar effects. Our previous
world's first randomized controlled trial (RCT) manipulated the parameters of the ROC
experience by increasing the demands of postural control during the course of locomotion. The
initial findings were positive and inspiring. After an intensive 12-week training program,
toddlers with motor delays in the ROC-Stand group had significant improvements in mobility
and social function. Moreover, the ROC-Stand group tended to have the most improvements than
the ROC-Sit and conventional therapy groups, including mobility, social function and mastery
motivation. The ROC-Stand group also had the highest goal achievement scores. In addition,
the pilot results of caregivers' perceptions showed over 80% of the caregivers involved in
the ROC training programs had decreased concerns on children's motor and social development.
Their expectations changed due to the observed improvements in children's movements,
cognition, and motivation. The intensive 3-month ROC training program, particularly the
standing one, was feasible and beneficial for toddlers with motor delays and their
caregivers.
However, the severity level of motor delay should be considered in the early PMDs and require
further investigation on the related treatment effects. Thus, a further study of toddlers
with different severity levels of motor delays will provide us a full investigation on the
effectiveness of ROC-Stand training on mobility, psychosocial function and locomotor
experience. Moreover, the integration of information regarding the social looking behaviors,
motor cost, caregiver-child interactions and caregivers' perceptions will be beneficial for
clarifying the influences of these factors on the outcomes. The purpose of this study is to
examine the effectiveness of ROC-Stand training on mobility, psychosocial function and social
looking in toddlers with mild and moderate motor disabilities. To obtain the information of
social looking and interactions with their caregivers, the investigator will use the
lightweight, head-mounted action camera to record children's behaviors. Up to now, there is
no ROC-related study applying this methodology to investigate the ecological validity in
toddlers with motor delays. This design may help us to capture the novelty and variability of
real-world locomotor experience regarding social looking, exploration and interactions.
The specific aims of this study are: 1) to compare the effectiveness of the ROC-Stand
training on mobility, psychosocial function and social looking with conventional therapy in
toddlers with mild and moderate motor delays, 2) to compare the effectiveness of ROC-Stand
training on body function level and environmental factors with conventional therapy in
toddlers with mild and moderate motor delays, according to the ICF, and 3) to determine the
effects of ROC-Stand training on the relationship among social looking, caregiver-child
interactions and mastery motivation in toddlers with mild and moderate motor delays.
Study Design: A randomized, multiple group pretest-posttest control group design will be
applied. Four groups will be involved in this project: ride-on car training with a standing
posture for toddlers with mild motor delays (ROC-Stand(Mild)), ride-on car training with a
standing posture for toddlers with moderate motor delays (ROC-Stand(Mod)), conventional
therapy for toddlers with mild motor delays (Control(Mild)) and conventional therapy for
toddlers with moderate motor delays (Control(Mod)). The investigator will use stratified
randomization. They will be arranged to one of the two groups based on the motor composite
(MC) scores assessed by Bayley-III. Subsequently, the participants in each group will be
randomly assigned to either the ROC-Stand training program or conventional therapy program by
using a computer program (Research Randomizer Form www.randomizer.org). The study duration
for each participant is 24 weeks, including a 12-week training phase (intervention) and a
12-week follow-up phase.
There will be 4 groups, including the ROC-Stand(Mild) group (23 toddlers), the ROC-Stand(Mod)
group (23 toddlers), the Control(Mild) group (23 toddlers) and Control(Mod) group (23
toddlers). The age group of infants/preschool children is selected based on the previous
studies of ROC training in young children with motor disabilities.
Recruitment: The children will be recruited from self-referrals, health care practitioners,
or the hospitals in Taipei and Taoyuan, Taiwan where children with motor delays are receiving
outpatient rehabilitation. Parents/guardians will obtain information about the study through
the flyers and their therapists. When the research team contacts the parents, study will be
explained and parents will receive a letter detailing the procedure and given an opportunity
to ask questions. Parents/guardians will sign this informed consent form at the time of the
first visit.
Procedure: Before randomization, the participants will receive pre-intervention measurements,
including developmental assessments, the evaluations of environmental factors and
self-developed questionnaires. The self-developed questionnaires were designed to examine
parental perceptions on the training program and children's capabilities in the previous
studies. The pretest and posttest developmental assessments and questionnaires will be
completed in a testing room at Chang Gung University by a licensed occupational therapist who
is blinded to the study purpose and not involved in the training programs. These assessments
will occur on three occasions: before and after the 12-week training phase, i.e.,
intervention (T1 & T2) and the end of the 12-week follow-up phase (T3). After the pretest,
participants will be randomly assigned into 4 groups and started the training programs in the
university.
During the 12-week intervention, the locomotor experience of social looking behaviors and
interactions for the four training groups will be videotaped by the head-mounted action
cameras worn by the participants and the caregivers for one 2-hour session/per week at the
university. In addition, participants will wear three accelerometers on their wrists and
right hip to monitor the energy expenditure and activity counts during the intervention
phase. An activity log used in the previous studies will also be applied in the 4 groups to
record the training conditions and the caregiver's feedback on the training program every
week during the 12-week intervention. The activity log will be mostly qualitative data that
involves caregivers' descriptions. For the 12-week follow-up phase, all participants will not
receive any training program from the research team. They only have their regular therapy
from their own hospitals or clinics. The information of regular therapy, including the type,
the frequency and the dosage, will be collected at T1, T2 and T3.
Intervention: The research team and independent therapists will ask caregivers to identify
goals (before the first training session), and measure progress using goal-attainment scaling
(GAS) at T1, T2 and T3 time points for the four groups. Two independent licensed occupational
therapists (OTs) who will not involve the administration of assessments will provide the
ROC-Stand training and conventional therapy programs, respectively. All participants in the 4
groups will continue their regular therapy from their own hospitals or clinics throughout the
24-week duration of the study, including physical therapy, occupational therapy, and speech
therapy. All groups will receive the training program in the university for 2 hours/per
session, 2 sessions/per week for a total of 12-week intervention. On licensed, independent OT
will provide the ROC training programs and the other licensed, independent OT will provide
the conventional therapy. 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 programs for the two control group
will be based on developmental and motor learning theories.
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 Looking and Interactions Measures: To examine
participant's social looking and interactive behaviors, the following measures will be
obtained via coding video footage during the 12-week intervention phase. Because young
children, like adults, keep their eyes relatively centered in view most of the time. Thus,
studies have been applied the center of the visual field to indicate the focus point. On the
basis of these studies, the coding variables included face looking, body/toy/environment
looking, child's and social partner's vocalizations, child-initiated and caregiver-initiated
vocalizations/gesture, concurrent/overlapping vocalizations, conversation units and visual
scan.
To compare the baseline characteristics of the major 2 groups categorized as mild and
moderate motor delay, independent t-test (for data with normal distribution) and The
Mann-Whitney U test (for data with non-normal distribution) will be conducted. Data will be
analyzed based on an intention-to-treat analysis. A repeated measures analysis of variance
(group [4] × time [3]) will be employed to evaluate the treatment effects on the primary and
secondary outcomes among the 4 groups at T1, T2, and T3, followed by a post-hoc analysis
using Bonferroni test to determine between which groups the differences occur.
For those data collected during the 12-week intervention, descriptive statistics (frequency,
means, standard deviations) of social looking and interactions will be calculated and
repeated measures analysis of variance (group [4] × time [12]) will be used to compare the
effects among the 4 training groups during intervention. Furthermore, the quantitative data
of energy expenditure and activity counts obtained from the ActiGraph® during intervention
will be organized and calculated. A repeated measures analysis of variance (group [4] × time
[12]) will also be used to compare the differences among the 4 groups. The mean frequency of
total social looking and interactions will be calculated from the coding results of the
12-week intervention. SPSS 20.0 (SPSS Inc. Chicago, Illinois, USA) will be used for
statistical analysis. Significance level will be set at p < 0.05.