Evidence-Based Neurorehabilitation in Children With CP

NCT ID: NCT03128385

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2024-12-31

Brief Summary

This 3-year research project aims to investigate and compare the treatment effectiveness (in terms of motor and psychosocial outcomes) and potential predictors (in terms of demographical, biological and psychosocial domains) of the intensive and distributed Child- and Family-Friendly CIT protocols with an equivalent intervention period in children with CP by quasi randomized controlled study design. In addition, the selection and examination of outcome measures were based on the ICF-CY model to provide comprehensively documents.

Detailed Description

Upper limb dysfunction is a common and disabling consequence of children with cerebral palsy (CP). As children with hemiplegia primarily have one better funcitoning side of their body and one more affected side, they often tend not to use the affected extremity resulting in the phenoema of developmental disregard. Recent evidence suggests that constraint-induced therapy (CIT) is the most effective technique to improve the use of the affected hand and reduce the developmental disregard in children with CP. However, despite the cumulative evidence supporting the effects of pediatric CIT, the concerns of feasibility and gaps of current knowledge prompt us to conduct this current proposal. The concerns of the feasibility include this approach is emotionally problematic at early stages and researchers suggested that the orginal CIT protocols may be too intrusive for children and their families. The gaps of current knowledge include: no study has directly investigated the effectiveness differences between various CIT models; no study examines, monitors and compares the psychosocial outcomes while receiving the CIT protocols for children and their parents systematically and comprehensively; and no study investigates the possible clinical characteristics of children that may influence the training effects of the various CIT models.

Investigators will recruit a total of 60 children with CP from the CP Association, medical centers, and special educational systems and participants will be assigned to the two intervention groups. The intensive CIT is delivered by the group-based design with 6 hours a day for 6 days (36 hours in total) and the distributed CIT will be delivered by individualized home-based intervention with 2.25 hours a day, two times a week, for 8 weeks (36 hours in total).

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive CIT Model Program

In day camp model, the therapist will monitor and modify the activities to fit each child's ability and need (e.g. implementing task analysis, grading the challenge for each individual with varying capabilities) to make sure the intervention quality is equivalence to the individualized treatment.The day camp model will be arranged as "Adventure Camp" that decorating the treatment place as the adventure world and the participants take role as a warrior. This novel design is mean to enhance and motivate the engagement of participation.

Group Type: EXPERIMENTAL

Intensive CIT Model Program

Intervention Type: OTHER

Day Camp Model:

1. The treatment was delivered in group-based design, 6 hours a day for 6 days (36 hours in total)

2. constraint of the unaffected hand to encourage the use of the affected hand

3. massed and repetitive practice of the affected hand during the period of constraint

4. use of behavioral techniques termed "shaping" to train the affected hand

Distributed CIT Model Program

All treatment activities will be focused on the training of the more affected upper limbs with contextual restraint. Investigators choose this child-friendly way to restraint children's non or less impaired hand without any devices. Investigators will provide a unilateral activities and verbal cues to restraint participants' non or less affected side. All tailored activities will be designed as fun and age-appropriated based on the child's preference and parents' concerns. In order to help children to generalize the therapeutic gains to the real world environment, the intervention will take place in the natural environment such as home or school where it may be easier to identify real practical problems and makes the family or caregivers involved more closely and directly.

Group Type: EXPERIMENTAL

Distributed CIT Model Program

Intervention Type: OTHER

Home-Based Model:

1. The participants will receive individualized interventions, 2.25 hours a day, two times a week for 8 weeks (36 hours in total).

2. constraint of the unaffected hand to encourage the use of the affected hand

3. massed and repetitive practice of the affected hand during the period of constraint

4. use of behavioral techniques termed "shaping" to train the affected hand

Interventions

Intensive CIT Model Program

Day Camp Model:

1. The treatment was delivered in group-based design, 6 hours a day for 6 days (36 hours in total)

2. constraint of the unaffected hand to encourage the use of the affected hand

3. massed and repetitive practice of the affected hand during the period of constraint

4. use of behavioral techniques termed "shaping" to train the affected hand

Intervention Type: OTHER

Distributed CIT Model Program

Home-Based Model:

1. The participants will receive individualized interventions, 2.25 hours a day, two times a week for 8 weeks (36 hours in total).

2. constraint of the unaffected hand to encourage the use of the affected hand

3. massed and repetitive practice of the affected hand during the period of constraint

4. use of behavioral techniques termed "shaping" to train the affected hand

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. aged between 5 and 13 years

2. diagnosed with congenital hemiplegic or children with CP with one more affected side

3. apparently disuse phenomenon of the more affected hand at spontaneous contexts

Participants will be exclude for:

1. excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment

2. severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation

3. injections of botulinum toxin type A or operations on the UE within 6 months

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tien-Ni Wang

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, Zhongzheng District, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Tien-Ni Wang

Role: CONTACT

tnwang@ntu.edu.tw

3366-8163

Facility Contacts

Tien-Ni Wang

Role: primary

tnwang@ntu.edu.tw

02-33668163

References

Wang TN, Liang KJ, Liu YC, Shieh JY, Chen HL. Effects of Intensive Versus Distributed Constraint-Induced Movement Therapy for Children With Unilateral Cerebral Palsy: A Quasi-Randomized Trial. Neurorehabil Neural Repair. 2023 Feb-Mar;37(2-3):109-118. doi: 10.1177/15459683231162330. Epub 2023 Mar 28.

Reference Type: DERIVED

PMID: 36987387 (View on PubMed)

Other Identifiers

201701011RINC

Identifier Type: -

Identifier Source: org_study_id