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

NCT04516876 | Recruiting

• 1 other identifier: 202004060RIND
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebral Palsy

Keywords

cerebral palsy, bimanual intensive training, occupational therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  baseline, after one week, after 2 months, after 6 months

Secondary Outcomes (11)

• Score changes of Bruininks-Oseretsky Test of Motor Proficiency

  baseline, after one week, after 2 months, after 6 months

• Score changes of Box and Block test

  baseline, after one week, after 2 months, after 6 months

• Performance changes of motion analysis

  baseline, after one week, after 2 months, after 6 months

• Score changes of Pediatric Motor Activity Log-Revised

  baseline, after one week, after 2 months, after 6 months

• Score changes of ABILHAND-kids Questionnaire

  baseline, after one week, after 2 months, after 6 months

Study Arms (1)

Camp-based bimanual intensive training(BIT)

EXPERIMENTAL

Other: Camp-based bimanual intensive training(BIT)

Interventions

Camp-based bimanual intensive training(BIT) OTHER

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.

Camp-based bimanual intensive training(BIT)

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University, Department of Occupational Therapy

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Tien-Ni Wang, PhD

CONTACT

+886 23366-8163; tnwang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 18, 2020
• Study Start: August 3, 2020
• Primary Completion: August 3, 2024
• Study Completion: August 3, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TW (1)