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Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Camp-based bimanual intensive training(BIT)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, bimanual intensive training, occupational therapy

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of cerebral palsy(CP) with one or more affected sides.
  2. Considerable nonuse of the affected upper limb (amount-of-use score of the Pediatric Motor Activity Log < 2.5).
  3. No excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment.
  4. No severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner 's clinical observation.
  5. No injections of botulinum toxin type A or operations on the upper limb within 6 months.

Sites / Locations

  • National Taiwan University, Department of Occupational TherapyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Camp-based bimanual intensive training(BIT)

Arm Description

Outcomes

Primary Outcome Measures

Score changes of Melbourne Assessment 2
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.

Secondary Outcome Measures

Score changes of Bruininks-Oseretsky Test of Motor Proficiency
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.
Score changes of Box and Block test
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.
Performance changes of motion analysis
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.
Score changes of Pediatric Motor Activity Log-Revised
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.
Score changes of ABILHAND-kids Questionnaire
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 .
Score changes of Pediatric Evaluation of Disability Inventory
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 .
Score changes of Dimensions of Mastery Questionnaire
Score changes of Test of Playfulness
Score changes of Pediatric Engagement Questionnaire
Score changes of Client Satisfaction Questionnaire
Score changes of Parenting Stress Index-Short Form
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

Full Information

First Posted
August 13, 2020
Last Updated
February 16, 2023
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04516876
Brief Title
Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
Official Title
Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
August 3, 2023 (Anticipated)
Study Completion Date
August 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research project aims to investigate the feasibility, efficacy, and acceptability of camp-based model of BIT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
cerebral palsy, bimanual intensive training, occupational therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Camp-based bimanual intensive training(BIT)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Camp-based bimanual intensive training(BIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Score changes of Melbourne Assessment 2
Description
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.
Time Frame
baseline, after one week, after 2 months, after 6 months
Secondary Outcome Measure Information:
Title
Score changes of Bruininks-Oseretsky Test of Motor Proficiency
Description
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.
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Score changes of Box and Block test
Description
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.
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Performance changes of motion analysis
Description
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.
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Score changes of Pediatric Motor Activity Log-Revised
Description
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.
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Score changes of ABILHAND-kids Questionnaire
Description
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 .
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Score changes of Pediatric Evaluation of Disability Inventory
Description
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 .
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Score changes of Dimensions of Mastery Questionnaire
Time Frame
baseline, after one week, after 2 months, after 6 months
Title
Score changes of Test of Playfulness
Time Frame
from the first day to the sixth day of the intervention
Title
Score changes of Pediatric Engagement Questionnaire
Time Frame
from the first day to the sixth day of the intervention
Title
Score changes of Client Satisfaction Questionnaire
Time Frame
from the first day to the sixth day of the intervention
Title
Score changes of Parenting Stress Index-Short Form
Description
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
Time Frame
baseline, after one week, after 2 months, after 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tien-Ni Wang, PhD
Phone
+886 23366-8163
Email
tnwang@ntu.edu.tw
Facility Information:
Facility Name
National Taiwan University, Department of Occupational Therapy
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tien-Ni Wang, PhD
Phone
886 23366-8163
Email
tnwang@ntu.edu.tw

12. IPD Sharing Statement

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Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy

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