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Trial registered on ANZCTR


Registration number
ACTRN12624001136594
Ethics application status
Approved
Date submitted
23/07/2024
Date registered
20/09/2024
Date last updated
20/09/2024
Date data sharing statement initially provided
20/09/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of hand-arm bimanual intensive therapy including lower extremities (habit-ile) and home-based habit-ile among children with bilateral cerebral palsy
Scientific title
Effectiveness of hand-arm bimanual intensive therapy including lower extremities (habit-ile) and home-based habit-ile among children with bilateral cerebral palsy
Secondary ID [1] 312561 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 334458 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331078 331078 0 0
Occupational therapy
Physical Medicine / Rehabilitation 331079 331079 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is based on motor learning and neuroplasticity principles. In addition to addressing the upper extremities, HABIT-ILE also incorporates the trunk and lower extremities, emphasizing the simultaneous control of both upper and lower extremities.

Dose: Children in the intervention group will receive in total 55 hours of HABIT-ILE from the therapists in camp with 10 hours of home-based HABIT-ILE in 10 consecutive days.

Mode: Groups of 13 children delivered (2:1 therapist to child ratio).

Content and tailoring: For children in group A, they will have HABIT-ILE training in camp for 5.5 hours a day for ten consecutive days, a total of 55 hours. After the daily 5.5 HABIT-ILE training in camp, go home for 1-hour home-based HABIT-ILE training with the therapist remotely guiding the caregiver. Participants in group A will not continue to receive the rehabilitation they originally received in the hospital. Therapists should fill the HABITILE daily log and fill Home-based HABIT-ILE daily log after communicating with Caregivers After the intervention, the children will be reassessed again. A child's abilities and developed functional goals are taken into consideration when selecting activities and tasks to carry out during the intervention. HABIT-ILE involves structured bimanual activities, such as games or functional tasks, requiring systematically the use of both hands, while also involving postural and lower extremity demands. During camp, both upper and lower extremity motor difficulty is gradually increased in complexity as children master the skills.

Intervention Providers: Interventions are provided by physical therapists and occupational therapists under the guidance of the HABIT-ILE developers.

Target intensity: During the intervention, the routine is organized as follows. From 8:00 in the morning, the supervisor will lead the therapist in confirming the list of activities and making preparations. Ensure that the toys needed are well prepared and have been checked. There will be an intervention starting at 9 o'clock until 2.30 p.m., lasting for 5.5 hours, including a lunch activity at noon. Afterward, the therapist communicates with the caregivers for 30-50 minutes and teaches them what games and activities their child is most interested in during the day. This is so that they can have 1 hour of HABIT-ILE at home under remote video supervision once they return home.

Fidelity: HABIT-ILE's original expert team and researcher of this project will supervise therapists throughout the process. Prior to research, supervisors and researcher will train therapists on the principles of motor skill learning, as the principles used for HABITILE. First, a total of eight-hour lectures and a well-prepared handbook designed by supervisors and researchers will be given to recruited therapists. Second, the day before HABIT-ILE and home-based HABIT-ILE, supervisors and researcher will conduct a group meeting with the therapists. Therapists will be supervised in designing interventions and choosing appropriate activities for children. Additionally, supervisors and researcher will guide the grading strategy from accessible to difficult. The interaction between the therapists and the children will be observed during the intervention. Therapists will be provided guidance to make timely adjustments when necessary. There will be assistance from supervisors and researcherin resolving the problems raised. A therapist will guide the caregiver through a home-based HABIT-ILE session through online meeting platform and observe the child's performance to ensure the training plan is adjusted accordingly. After the day's treatment, a discussion time of about an hour is arranged. The therapist needs to report on the child's situation today and discuss with supervisors and researcher to formulate an updated intervention plan for the next day.

Games and activities children may receive: HABIT-ILE involves structured bimanual activities, such as games or functional tasks,requiring systematically the use of both hands, while also involving postural and lower extremity demands. During camp, both upper and lower extremity motor difficulty is gradually increased in complexity as children master the skills. As an example, the activities to determine the evolution of the more affected hand in bimanual activities may begin with it acting as a passive support (such as stabilizing paper with weight to make crafts), progressing toward more complex activities (such as grasping or holding a Lego block). A similar progression is made for postural and lower extremity challenges, starting with more stable positions (e.g., sitting on a bench while playing at a table), then progressing to more demanding situations considering balance (e.g., sitting on a fitness ball) or dynamic postures (e.g., standing, walking, or running when possible). The activities always involve the upper and lower extremities, along with postural control. Either the upper or lower extremities increase in difficulty, but not both simultaneously.

Sampling method: Recruitment of subjects is conducted using the convenience sample method. Participants were assigned to the intervention or control group in the order in which they entered the study (the first 13 participants will be assigned to the intervention
group, and the last 13 participants were assigned to the control group).
Intervention code [1] 329074 0
Rehabilitation
Intervention code [2] 329246 0
Treatment: Other
Comparator / control treatment
Children in control group will receive in total 55-hour usual care in the rehabilitation hospital. These interventions include occupational therapy, physical therapy. There are neurodevelopmental treatments (NDT) that are used in the intervention. Rather than relying on a set of standardised techniques, this approach relies on clinical reasoning to make decisions. Prior to beginning or adjusting the treatment, the therapist observes, analyses, and interprets the performance of the task. A child's specific needs, aims, and goals are taken into account when formulating the approach. The NDT approach takes the patient's sensory-motor, emotional, social, and functional problems into consideration when determining the best treatment plan for them. The theory behind NDT is that by inhibiting or modifying spastic limitations and abnormal reflex patterns it is possible to recover movement that has been affected by these deficits. During therapy, the therapist helps the patient to move through various points of control, such as the neck, shoulders, and pelvis, to help them to move. To enhance motor performance, the therapist uses sensory inputs, as well as compensatory motor behaviors, in order to enhance motor performance.

The control group received in total 10 hour cognitive training provided by the caregiver, including reading storybooks, learning English, recognising colours, calculating and recognising physical quantities including shape, size, weight, etc., watching videos and reviewing the content learned in kindergarten and primary school classes. The cognitiveactivity will not involve physical activity. The purpose is to provide the children in the control group with similar attention from the therapist and caregiver.
Control group
Active

Outcomes
Primary outcome [1] 338851 0
Motor Proficiency (The Bruininks-Oseretsky Test of Motor Proficiency-2).
Timepoint [1] 338851 0
Immediately post intervention (within two days).
Primary outcome [2] 338854 0
Hand function (Jebsen Hand Function Test).
Timepoint [2] 338854 0
Immediately post intervention (within two days).
Primary outcome [3] 338855 0
Occupational performance score (Canadian occupational performance measure).
Timepoint [3] 338855 0
Immediately post intervention (within two days).
Secondary outcome [1] 437689 0
Caregiver’s perception of the upper extremity function of children (Caregiver Functional Use Survey).
Timepoint [1] 437689 0
Immediately post intervention (Within three days).
Secondary outcome [2] 437690 0
Gross motor function (Gross Motor Function Measure 66 Item Set).
Timepoint [2] 437690 0
Immediately post intervention (within three days).
Secondary outcome [3] 437691 0
Quality of life (Pediatric Quality of Life Inventory).
Timepoint [3] 437691 0
Immediately post intervention (within two days).
Secondary outcome [4] 437692 0
Parenting Stress (Parenting Stress Index).
Timepoint [4] 437692 0
Immediately post intervention (within two days).
Secondary outcome [5] 437695 0
Implementation dose.
Timepoint [5] 437695 0
Daily after daily log has been completed.
Secondary outcome [6] 438757 0
Occupational satisfaction scores (Canadian Occupational Performance Measure).
Timepoint [6] 438757 0
Immediately post intervention (within two days).
Secondary outcome [7] 438758 0
Perceptions of compliance of therapist with the supervision.
Timepoint [7] 438758 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [8] 438759 0
The difficulty for therapists to complete the HABIT-ILE.
Timepoint [8] 438759 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [9] 438760 0
The child’s tolerance of the intervention at camp.
Timepoint [9] 438760 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [10] 438761 0
The child’s attention at camp.
Timepoint [10] 438761 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [11] 438762 0
Therapist's satisfaction with the intervention offered.
Timepoint [11] 438762 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [12] 438763 0
The child’s performance at camp.
Timepoint [12] 438763 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [13] 438764 0
Difficulty in completing home-based HABIT-ILE under guidance from the therapist.
Timepoint [13] 438764 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [14] 438765 0
The child’s attention during the intervention at home.
Timepoint [14] 438765 0
Daily for 10 days post-intervention, after daily log has been completed.
Secondary outcome [15] 438766 0
The caregiver’s satisfaction with the intervention offered at home.
Timepoint [15] 438766 0
Daily for 10 days post-intervention, after daily log has been completed.

Eligibility
Key inclusion criteria
Inclusion criteria for child’s participants:
i. age 5 - 12 years old;
ii. diagnosed as bilateral CP with Gross motor functional classification (GMFCS) from
levels II to IV;
iii. could grasp light objects and lift the more affected arm 15cm above a table surface;29
iv. could understand the game and test instructions.

Inclusion criteria for caregiver’s participants:
i. able to provide one-on-one 1-hour training to the child per day;
ii. have a computer or iPad with a camera;
iii. had high school education level;
iv. age 59 years or younger.
Minimum age
5 Years
Maximum age
59 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for child’s participants:
i. has uncontrolled seizures;
ii. received botulinum neurotoxin injections or orthopaedic surgery in the previous six
months or during the study period;
iii. visual problems interfering with treatment;
iv. inability to walk even with a walker.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data analysis will be conducted using IBM Statistical Package for the Social Sciences 25 (SPSS V25). The p-value for significance is set at p < 0.05, and the confidence interval is 95%. . A test of normality was performed using the Shapiro-Wilk test. A test of normality was performed using the Shapiro-Wilk test. Gender of children, Caregiver Relationship with child, Level of education, GMFCS will be presented as frequency, percentage, and proportion. Age of children, Age of caregiver, BOT-2, JHFT, GMFM-66-IS, CFUS, PedsQL, PSI, HABIT-ILE daily log, Home-based HABIT-ILE daily log will be presented as Mean,
Standard Deviation, Minimum, Maximum or Median, Interquartile range. Age of
children, Age of caregiver, BOT-2, JHFT, GMFM-66-IS, CFUS, PedsQL, PSI,
HABIT-ILE daily log, Home-based HABIT-ILE daily log will be performed using
repeated-measures analysis of variance (ANOVA) with one between-subjects factor
(treatment and control) and one within-subjects factor (pre- and post-intervention) or
Kruskal-Wallis test to detect whether there will be a significant difference.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
11/07/2023
Date of last participant enrolment
Anticipated
23/02/2026
Actual
Date of last data collection
Anticipated
11/03/2026
Actual
Sample size
Target
26
Accrual to date
13
Final
Recruitment outside Australia
Country [1] 26435 0
China
State/province [1] 26435 0

Funding & Sponsors
Funding source category [1] 316988 0
University
Name [1] 316988 0
The Beijing Language and Culture University
Country [1] 316988 0
China
Primary sponsor type
Individual
Name
Qu Ya-lan - Universiti Kebangsaan Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 319235 0
None
Name [1] 319235 0
Address [1] 319235 0
Country [1] 319235 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315742 0
Universiti Kebangsaan Malaysia Research Ethics Committee
Ethics committee address [1] 315742 0
Ethics committee country [1] 315742 0
Malaysia
Date submitted for ethics approval [1] 315742 0
06/11/2023
Approval date [1] 315742 0
14/06/2024
Ethics approval number [1] 315742 0
Ethics committee name [2] 315746 0
Beijing Language and Culture University Human Experimentation Ethics Committee
Ethics committee address [2] 315746 0
Ethics committee country [2] 315746 0
China
Date submitted for ethics approval [2] 315746 0
01/06/2023
Approval date [2] 315746 0
10/07/2023
Ethics approval number [2] 315746 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135670 0
Dr Dzalani Harun
Address 135670 0
Program of Occupational Therapy, Center for Rehabilitation & Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz, Kuala Lumpur 50300, Malaysia
Country 135670 0
Malaysia
Phone 135670 0
+60392897904
Fax 135670 0
Email 135670 0
dzalani@ukm.edu.my
Contact person for public queries
Name 135671 0
Qu Ya-lan
Address 135671 0
Center for Rehabilitation & Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz, Kuala Lumpur 50300, Malaysia
Country 135671 0
Malaysia
Phone 135671 0
+601157879366
Fax 135671 0
Email 135671 0
p115205@siswa.ukm.edu.my
Contact person for scientific queries
Name 135672 0
Dzalani Harun
Address 135672 0
Program of Occupational Therapy, Center for Rehabilitation & Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia Jalan Raja Muda Abdul Aziz, Kuala Lumpur 50300, Malaysia
Country 135672 0
Malaysia
Phone 135672 0
+60392897904
Fax 135672 0
Email 135672 0
dzalani@ukm.edu.my

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24011Informed consent form    388153-(Uploaded-18-07-2024-19-09-01)-INFORMED CONSENT FORM .pdf



Results publications and other study-related documents

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Documents added automatically
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