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

NCT ID: NCT04516876

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-03
• Study Completion Date: 2024-08-03

Brief Summary

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

Conditions

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Camp-based bimanual intensive training(BIT)

Group Type: EXPERIMENTAL

Camp-based bimanual intensive training(BIT)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

National Taiwan University, Department of Occupational Therapy

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tien-Ni Wang, PhD

Role: CONTACT

tnwang@ntu.edu.tw

+886 23366-8163

Facility Contacts

Tien-Ni Wang, PhD

Role: primary

tnwang@ntu.edu.tw

886 23366-8163

Other Identifiers

202004060RIND

Identifier Type: -

Identifier Source: org_study_id