- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04516876
Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
March 8, 2024 updated by: National Taiwan University Hospital
This research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tien-Ni Wang, PhD
- Phone Number: +886 23366-8163
- Email: tnwang@ntu.edu.tw
Study Locations
-
-
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Taipei, Taiwan, 100
- Recruiting
- National Taiwan University, Department of Occupational Therapy
-
Contact:
- Tien-Ni Wang, PhD
- Phone Number: 886 23366-8163
- Email: tnwang@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Diagnosis of cerebral palsy(CP) with one or more affected sides.
- Considerable nonuse of the affected upper limb (amount-of-use score of the Pediatric Motor Activity Log < 2.5).
- No excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment.
- No severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner 's clinical observation.
- No injections of botulinum toxin type A or operations on the upper limb within 6 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Camp-based bimanual intensive training(BIT)
|
The day-camp BIT model will be delivered in a group-based design.
In day-camp model, each child is assigned to a trained therapist to maintain at least a 1:1 to 1:2 ratios of therapy and child.
The therapist will monitor and modify the activities to fit each individual's ability and need to make sure the intervention quality is equivalence to the individualized treatment method.
The chosen tasks of each intervention session have to be considering the child's preference, age-appropriated, and at the right level of difficulty.
Target movements are embedded in the functional activities, whereby the environment is manipulated to vary task requirement and the difficulty is graded to match the child's capacity.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score changes of Melbourne Assessment 2
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The Melbourne Assessment 2(MA2) was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years.The four main elements of movement quality include (1) amount of active ROM; (2) accuracy; (3) dexterity of finger movements; and (4) fluency or smoothness of movement.
The scoring sheet consists of 3-, 4-, or 5-point scales from 0 to 4 that allocate scores on the 14 items.Higher scores mean a better outcome.
|
baseline, after one week, after 2 months, after 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score changes of Bruininks-Oseretsky Test of Motor Proficiency
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The subtest 3 of the Bruininks-Oseretsky Test(BOT-2), manual dexterity (MD), will be used to assess a child's upper limb dexterity.
The subtests 3 of the BOT-2 consist of 5 goal-directed activities that involve reaching, grasping, and bimanual coordination with small objects to investigate a child's upper limb manual function.Higher scores mean a better outcome.
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baseline, after one week, after 2 months, after 6 months
|
Score changes of Box and Block test
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The Box and Block test (BBT) assesses manual dexterity by county the number of blocks that are transferred with a single hand from one compartment to another within 60 seconds.Higher scores mean a better outcome.
|
baseline, after one week, after 2 months, after 6 months
|
Performance changes of motion analysis
Time Frame: baseline, after one week, after 2 months, after 6 months
|
Three-dimensional marker trajectory data will be measured using a motion analysis system (Vicon MX, Oxford Metrics Group, U.K.).
Twenty-eight passive infrared retroreflective markers will be attached to the skin of the body segments to track the motion of the body segments.
For the performance outcome measures, endpoint variables during reach-to-grasp task, namely reaction time, movement time, movement unit, peak velocity and its time percentage during the movement time will be calculated using the wrist marker.
For the performance production measures, joint angles of the shoulder, elbow and wrist during reach-to-grasp task will also be calculated to represent the motor strategy of children with CP before and after intervention.
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baseline, after one week, after 2 months, after 6 months
|
Score changes of Pediatric Motor Activity Log-Revised
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The Pediatric Motor Activity Log-Revised(PMAL-R) is a parent-reported evaluative tool used to capture the spontaneous use of the affected upper limb in 22 daily activities.
Each activity is rated by parents/careers on two set (how often and how well) of 6-point ordinal scales (0-5).
The 'how often' scale measures amount of use, and the 'how well' scale measures quality of movement, of the affected upper limb.Higher scores mean a better outcome.
|
baseline, after one week, after 2 months, after 6 months
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Score changes of ABILHAND-kids Questionnaire
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The ABILHAND-Kids questionnaire is a Rasch-based assessment that measures children's perceived difficulty in performing ADL that require the use of the bilateral upper limbs.
It contains 21 items measuring manual ability and is rated on a 3-point response scale(0-2).
The parent is asked to fill in the questionnaire by estimating their child's ease or difficulty in performing each activity, irrespective of the limb(s) the child actually use and whatever the strategies used to perform the activity.Higher scores mean a better outcome .
|
baseline, after one week, after 2 months, after 6 months
|
Score changes of Pediatric Evaluation of Disability Inventory
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The Pediatric Evaluation of Disability Inventory(PEDI) is a parent-reported questionnaire.
It contains two subscales :(1)functional skill scale (2)caregiver assistance scale.
The parent is asked to fill in the questionnaire by estimating their child's performance capability in 197 items in three domains :(1)self-care (2)mobility (3)social is rated on a 2-point response scale(0-1).
In caregiver assistance scale, the needs of caregiver assistance to complete each activity are scored from 0 to 5 point.Higher scores mean a better outcome in both parts .
|
baseline, after one week, after 2 months, after 6 months
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Score changes of Dimensions of Mastery Questionnaire
Time Frame: baseline, after one week, after 2 months, after 6 months
|
baseline, after one week, after 2 months, after 6 months
|
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Score changes of Test of Playfulness
Time Frame: from the first day to the sixth day of the intervention
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from the first day to the sixth day of the intervention
|
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Score changes of Pediatric Engagement Questionnaire
Time Frame: from the first day to the sixth day of the intervention
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from the first day to the sixth day of the intervention
|
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Score changes of Client Satisfaction Questionnaire
Time Frame: from the first day to the sixth day of the intervention
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from the first day to the sixth day of the intervention
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Score changes of Parenting Stress Index-Short Form
Time Frame: baseline, after one week, after 2 months, after 6 months
|
The Parenting Stress Index-Short Form(PSI-SF) is direct derivative from the Parenting Stress Index (PSI) full-length test which was created to sample a diverse range of potential influences on parenting practices to address the need for a psychometrically sound but brief screening measure of parenting stress.
All 36 items of the PSI-SF consist of three subscales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
Each subscale consists of 12 items rated from 1 (strongly disagree) to 5 (strongly agree).
High scores on the subscale and PSI-SF total score indicate greater level of stress
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baseline, after one week, after 2 months, after 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 3, 2020
Primary Completion (Estimated)
August 3, 2024
Study Completion (Estimated)
August 3, 2024
Study Registration Dates
First Submitted
August 13, 2020
First Submitted That Met QC Criteria
August 17, 2020
First Posted (Actual)
August 18, 2020
Study Record Updates
Last Update Posted (Actual)
March 12, 2024
Last Update Submitted That Met QC Criteria
March 8, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202004060RIND
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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