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

• ClinicalTrials.gov Identifier: NCT04516876
• Recruitment Status: Recruiting
• First Posted: August 18, 2020
• Last Update Posted: January 20, 2022
• Sponsor: National Taiwan University Hospital
• Information provided by (Responsible Party): National Taiwan University Hospital

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Cerebral Palsy	Other: Camp-based bimanual intensive training(BIT)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy Research of Bimanual Intensive Training in Children With Hemiplegic Cerebral Palsy
• Actual Study Start Date: August 3, 2020
• Estimated Primary Completion Date: August 3, 2023
• Estimated Study Completion Date: August 3, 2024

Arms and Interventions

Arm

Intervention/treatment

Experimental: Camp-based bimanual intensive training(BIT)

Other: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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 .
6. 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 .
7. Score changes of Dimensions of Mastery Questionnaire [ Time Frame: baseline, after one week, after 2 months, after 6 months ]
8. Score changes of Test of Playfulness [ Time Frame: from the first day to the sixth day of the intervention ]
9. Score changes of Pediatric Engagement Questionnaire [ Time Frame: from the first day to the sixth day of the intervention ]
10. Score changes of Client Satisfaction Questionnaire [ Time Frame: from the first day to the sixth day of the intervention ]
11. 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

Eligibility Criteria

• Ages Eligible for Study: 5 Years to 12 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Contacts

Contact: Tien-Ni Wang, PhD; +886 23366-8163; tnwang@ntu.edu.tw

Locations

Taiwan

National Taiwan University, Department of Occupational Therapy; Recruiting

Taipei, Taiwan, 100

Contact: Tien-Ni Wang, PhD 886 23366-8163 tnwang@ntu.edu.tw

Sponsors and Collaborators

National Taiwan University Hospital

More Information

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT04516876
• Other Study ID Numbers: 202004060RIND
• First Posted: August 18, 2020
• Last Update Posted: January 20, 2022
• Last Verified: January 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National Taiwan University Hospital:

cerebral palsy, bimanual intensive training, occupational therapy

Additional relevant MeSH terms:

Paralysis; Cerebral Palsy; Neurologic Manifestations; Nervous System Diseases; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases