Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
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
Query!
Secondary ID [1]
312561
0
None
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy
334458
0
Query!
Condition category
Condition code
Physical Medicine / Rehabilitation
331078
331078
0
0
Query!
Occupational therapy
Query!
Physical Medicine / Rehabilitation
331079
331079
0
0
Query!
Physiotherapy
Query!
Intervention/exposure
Study type
Interventional
Query!
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).
Query!
Intervention code [1]
329074
0
Rehabilitation
Query!
Intervention code [2]
329246
0
Treatment: Other
Query!
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.
Query!
Control group
Active
Query!
Outcomes
Primary outcome [1]
338851
0
Motor Proficiency (The Bruininks-Oseretsky Test of Motor Proficiency-2).
Query!
Assessment method [1]
338851
0
The Bruininks-Oseretsky Test of Motor Proficiency-2 (BOT-2) evaluates proficiency in a motor, including Fine Motor Composite (Fine Manual Control, Manual Coordination) and Gross Motor Composite (Body Coordination, Strength, and Agility). Fine Manual Control is divided into Fine Motor Precision - 7 items, and Fine Motor Integration - 8 items. Manual Coordination includes Manual Dexterity - 5 items, UpperLimb Coordination - 7 items. Body Coordination is classified into Bilateral Coordination subtest - 7 items and Balance - 9 items. The Strength and Agility composite is made up of five items each of Running speed agility and Strength. Fine Motor Precision, Fine Motor Integration, Manual Dexterity, and Running speed agility will be assessed in this study as a composite primary outcome.
Query!
Timepoint [1]
338851
0
Immediately post intervention (within two days).
Query!
Primary outcome [2]
338854
0
Hand function (Jebsen Hand Function Test).
Query!
Assessment method [2]
338854
0
The Jebsen Hand Function Test (JHFT) is designed to assess the fine and gross motor functions of the hand by simulating activities of daily living.
Query!
Timepoint [2]
338854
0
Immediately post intervention (within two days).
Query!
Primary outcome [3]
338855
0
Occupational performance score (Canadian occupational performance measure).
Query!
Assessment method [3]
338855
0
The Canadian occupational performance measure (COPM) is a semi-structured interview designed to detect respondents' perceived importance of activities, occupational performance and occupational satisfaction. During the COPM process, clients consider issues that they find difficult in three domains including self-care, productive leisure, and rate the importance of each on a scale of 1 to 10. Clients then prioritized the three issues and rated their performance with each on a scale of 1 to 10. The higher the score, the better the performance.
Query!
Timepoint [3]
338855
0
Immediately post intervention (within two days).
Query!
Secondary outcome [1]
437689
0
Caregiver’s perception of the upper extremity function of children (Caregiver Functional Use Survey).
Query!
Assessment method [1]
437689
0
Caregiver Functional Use Survey (CFUS) is a semi-structured instrumentation for evaluating the caregiver’s perception of the upper extremity function of children with USCP aged between three years six months and fifteen years six months in performing 14 bimanual tasks in real-life environments.In this study,the Chinese version of CFUS will be used.
Query!
Timepoint [1]
437689
0
Immediately post intervention (Within three days).
Query!
Secondary outcome [2]
437690
0
Gross motor function (Gross Motor Function Measure 66 Item Set).
Query!
Assessment method [2]
437690
0
Gross Motor Function Measure 66 (GMFM-66) measures gross motor function in children with CP with good psychometric properties. GMFM-66 has five domains: A. Lying and rolling, B. Sitting, C. Crawling and kneeling, D. Standing, E. Walking, running and jumping. Gross Motor Function Measure 66 Item Set (GMFM-66-IS) scores were derived by testing a subsample of GMFM-66 items. Item sets are of various lengths. There are 15 items in Item set 1, 29 items in Item set 2, 39 items in Item set 3, and 22 items in Item set 4. GMFM-66-IS scores are calculated using item scores from GMFM-88 following a decision tree process. Once an item set is selected, the test is performed and then the scores are inserted into the Gross Motor Capacity Assessment program to calculate the GMFM-66-IS score.
Query!
Timepoint [2]
437690
0
Immediately post intervention (within three days).
Query!
Secondary outcome [3]
437691
0
Quality of life (Pediatric Quality of Life Inventory).
Query!
Assessment method [3]
437691
0
Pediatric Quality of Life Inventory (PedsQL) is designed with different disease modules. PedsQL 3.0 CP module is specifically designed to measure health-related quality of life in children with CP. PedsQL 3.0 CP module includes seven subscales: Daily Activities, School Activities, Movement and Balance, Pain and Hurt, Fatigue, Eating Activities, Speech, and Communication. There are two scales, i.e., parallel child self-report and parent proxy report. Child self-report is suitable for children or adolescents ages 5–7, 8–12, and 13–18. Parent proxy-reports evaluate parents' perception of their child's quality of life at ages 2–4 years, 5–7 years, 8–12 years, and 13–18 years. In this study, the Chinese version of the parent proxy-report module of PedsQL 3.0 CP will be used.
Query!
Timepoint [3]
437691
0
Immediately post intervention (within two days).
Query!
Secondary outcome [4]
437692
0
Parenting Stress (Parenting Stress Index).
Query!
Assessment method [4]
437692
0
Parenting Stress Index (PSI) measures parenting stress using 120 items. Index-short form (PSI-SF) is developed based on the Parenting Stress Index (PSI). The short form consists of three factors: Parental Distress, Parent-Child Dysfunctional, and Difficult Child, with 12 items under each factor. PSI-SF, refined into 15-item and 3-factor versions (Parental Distress, Parent-Child Dysfunctional, Difficult Child) for use among Chinese parents that adopt Chinese culture, has strict internal consistency and supports convergent validity. This 15-item PSI will be used in this study.
Query!
Timepoint [4]
437692
0
Immediately post intervention (within two days).
Query!
Secondary outcome [5]
437695
0
Implementation dose.
Query!
Assessment method [5]
437695
0
The HABIT-ILE daily log will be used to record daily participation time at camp. Participants' participation time at home will be recorded using Home-based HABIT-ILE daily log. The dose equals the combined time spent in camp and at home within 10 days.
Query!
Timepoint [5]
437695
0
Daily after daily log has been completed.
Query!
Secondary outcome [6]
438757
0
Occupational satisfaction scores (Canadian Occupational Performance Measure).
Query!
Assessment method [6]
438757
0
The Canadian occupational performance measure (COPM) is a semi-structured interview designed to detect respondents' perceived importance of activities, occupational performance and occupational satisfaction. During the COPM process, clients consider issues that they find difficult in three domains including self-care, productive leisure, and rate the importance of each on a scale of 1 to 10. Clients then prioritized the three issues and rated their satisfaction with each on a scale of 1 to 10. The higher the score, the higher the satisfaction.
Query!
Timepoint [6]
438757
0
Immediately post intervention (within two days).
Query!
Secondary outcome [7]
438758
0
Perceptions of compliance of therapist with the supervision.
Query!
Assessment method [7]
438758
0
This will be tracked using the HABIT-ILE daily log, where therapists rate their compliance levels as perceived by themselves at camp. A 5-Point Likert Scale is used, with 1 representing the worst-case scenario and 5 representing the best-case scenario.
Query!
Timepoint [7]
438758
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [8]
438759
0
The difficulty for therapists to complete the HABIT-ILE.
Query!
Assessment method [8]
438759
0
This will be tracked using the HABIT-ILE daily log, where therapists rate the difficulty they encounter in completing the HABIT-ILE at camp. A 5-Point Likert Scale is used, with 1 representing the most difficult scenario and 5 representing the least difficult scenario.
Query!
Timepoint [8]
438759
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [9]
438760
0
The child’s tolerance of the intervention at camp.
Query!
Assessment method [9]
438760
0
This will be tracked using the Home-based HABIT-ILE daily log, where caregivers rate the child's tolerance of the intervention at camp. A 5-Point Likert Scale is used, with 1 representing the lowest tolerance and 5 representing the highest tolerance.
Query!
Timepoint [9]
438760
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [10]
438761
0
The child’s attention at camp.
Query!
Assessment method [10]
438761
0
This will be tracked using the HABIT-ILE daily log, where therapists rate the child’s attention during the intervention at camp. A 5-Point Likert Scale is used, with 1 representing the lowest attention and 5 representing the highest attention.
Query!
Timepoint [10]
438761
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [11]
438762
0
Therapist's satisfaction with the intervention offered.
Query!
Assessment method [11]
438762
0
This will be tracked using the HABIT-ILE daily log, where therapists rate their satisfaction with the intervention provided at camp. A 5-Point Likert Scale is used, with 1 representing the lowest satisfaction and 5 representing the highest satisfaction.
Query!
Timepoint [11]
438762
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [12]
438763
0
The child’s performance at camp.
Query!
Assessment method [12]
438763
0
This will be tracked using the HABIT-ILE daily log, where therapists rate the child’s performance during the intervention at camp. A 5-Point Likert Scale is used, with 1 representing the poorest performance and 5 representing the best performance.
Query!
Timepoint [12]
438763
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [13]
438764
0
Difficulty in completing home-based HABIT-ILE under guidance from the therapist.
Query!
Assessment method [13]
438764
0
This will be tracked using the Home-based HABIT-ILE daily log, where caregiver rate the difficulty of completing the home-based HABIT-ILE under guidance of therapist. A 5-Point Likert Scale is used, with 1 representing the highest difficulty and 5 representing the lowest difficulty.
Query!
Timepoint [13]
438764
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [14]
438765
0
The child’s attention during the intervention at home.
Query!
Assessment method [14]
438765
0
This will be tracked using the Home-based HABIT-ILE daily log, where caregiver rate the child’s attention during the intervention at home. A 5-Point Likert Scale is used, with 1 representing the lowest attention and 5 representing the highest attention.
Query!
Timepoint [14]
438765
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
Secondary outcome [15]
438766
0
The caregiver’s satisfaction with the intervention offered at home.
Query!
Assessment method [15]
438766
0
This will be tracked using the Home-based HABIT-ILE daily log, where caregivers rate their satisfaction with the intervention offered at home. A 5-Point Likert Scale is used, with 1 representing the lowest satisfaction and 5 representing the highest satisfaction.
Query!
Timepoint [15]
438766
0
Daily for 10 days post-intervention, after daily log has been completed.
Query!
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.
Query!
Minimum age
5
Years
Query!
Query!
Maximum age
59
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
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.
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
11/07/2023
Query!
Date of last participant enrolment
Anticipated
23/02/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
11/03/2026
Query!
Actual
Query!
Sample size
Target
26
Query!
Accrual to date
13
Query!
Final
Query!
Recruitment outside Australia
Country [1]
26435
0
China
Query!
State/province [1]
26435
0
Query!
Funding & Sponsors
Funding source category [1]
316988
0
University
Query!
Name [1]
316988
0
The Beijing Language and Culture University
Query!
Address [1]
316988
0
Query!
Country [1]
316988
0
China
Query!
Primary sponsor type
Individual
Query!
Name
Qu Ya-lan - Universiti Kebangsaan Malaysia
Query!
Address
Query!
Country
Malaysia
Query!
Secondary sponsor category [1]
319235
0
None
Query!
Name [1]
319235
0
Query!
Address [1]
319235
0
Query!
Country [1]
319235
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
315742
0
Universiti Kebangsaan Malaysia Research Ethics Committee
Query!
Ethics committee address [1]
315742
0
Universiti Kebangsaan Malaysia Research Ethics Secretariat, 1st Floor, Clinical Block, Chancellor Tuanku Muhriz Hospital, UKM Medical Centre, Jalan Yaacob Latif, Bandar Tun Razak, 56000 Cheras Kuala Lumpur. E-mail: sepukm@ukm.edu.my
Query!
Ethics committee country [1]
315742
0
Malaysia
Query!
Date submitted for ethics approval [1]
315742
0
06/11/2023
Query!
Approval date [1]
315742
0
14/06/2024
Query!
Ethics approval number [1]
315742
0
Query!
Ethics committee name [2]
315746
0
Beijing Language and Culture University Human Experimentation Ethics Committee
Query!
Ethics committee address [2]
315746
0
Beijing Language and Culture University 15 Xueyuan Road, Haidian District Beijing 100083, China
Query!
Ethics committee country [2]
315746
0
China
Query!
Date submitted for ethics approval [2]
315746
0
01/06/2023
Query!
Approval date [2]
315746
0
10/07/2023
Query!
Ethics approval number [2]
315746
0
Query!
Summary
Brief summary
Therapist-directed Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) in camp effectively improves both upper- and lower extremities function of children with bilateral cerebral palsy (CP). Home-based programs are a vital addition to intensive therapy offered by therapists in hospital or rehabilitation centres. The setting of home-based HABIT-ILE in children with bilateral CP has not been developed and its effectiveness is still unknown. This study aims determine the effectiveness of HABIT-ILE with home-based HABIT-ILE in improving upper and lower extremities function for children with bilateral CP. Besides, parental stress and children’s quality of life, occupational performance, and satisfaction will also be determined.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
135670
0
Dr Dzalani Harun
Query!
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
Query!
Country
135670
0
Malaysia
Query!
Phone
135670
0
+60392897904
Query!
Fax
135670
0
Query!
Email
135670
0
[email protected]
Query!
Contact person for public queries
Name
135671
0
Qu Ya-lan
Query!
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
Query!
Country
135671
0
Malaysia
Query!
Phone
135671
0
+601157879366
Query!
Fax
135671
0
Query!
Email
135671
0
[email protected]
Query!
Contact person for scientific queries
Name
135672
0
Dzalani Harun
Query!
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
Query!
Country
135672
0
Malaysia
Query!
Phone
135672
0
+60392897904
Query!
Fax
135672
0
Query!
Email
135672
0
[email protected]
Query!
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
24011
Informed consent form
388153-(Uploaded-18-07-2024-19-09-01)-INFORMED CONSENT FORM .pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF