Evidence-Based Neurorehabilitation in Children With CP

NCT03128385 | Recruiting

• 1 other identifier: 201701011RINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Upper limb neurorehabilitation; Neurological rehabilitation; Upper extremity

Outcome Measures

Primary Outcomes (3)

• "change" Melbourne Assessment 2 (MA2)

  The MA2 was developed to investigate the objective upper-limb movement in children with CP aged 2.5 to 15 years (Randall, Imms, Carey, \& Pallant, 2014). The test comprises 14 functional tasks (e.g., grasping a pellet, pointing, and etc), which are representative of the most important components of unilateral upper limb function, including reach, grasp, release, and manipulate.

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

• "change" Box and Block Test (BBT)

  The 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. In recent years, it has increasingly been used to assess gross manual dexterity of the affected versus the non-affected hand in children and young adolescents with hemiplegia cerebral palsy.

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

• "change" Pediatric Motor Activity Log-Revised (PMAL-R)

  The PMAL-R is adapted from the Pediatric Motor Activity Log (Taub et al., 2004), which was developed as an outcome measure for evaluating the effectiveness of CIT in children with CP. It 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. The PMAL-R testing manual is available online.

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

Secondary Outcomes (9)

• "change" Bruininks-Oseretsky Test of Motor Proficiency, Second Edition (BOT-2)

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

• "change" Motion Analysis

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

• "change" ABILHAND-Kids

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

• "change" Pediatric Evaluation of Disability Inventory (PEDI)

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

• "change" Dimensions of Mastery Questionnaire (DMQ)

  Intensive and CIT Model Program: baseline, 1 week, 2 months, 6 months; Distributed CIT Model Program: baseline, 1 months, 2 months, 6 months

Study Arms (2)

Intensive CIT Model Program

EXPERIMENTAL

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.

Other: Intensive CIT Model Program

Distributed CIT Model Program

EXPERIMENTAL

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.

Other: Distributed CIT Model Program

Interventions

Intensive CIT Model Program 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

Intensive CIT Model Program

Distributed CIT Model Program 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

Distributed CIT Model Program

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• aged between 5 and 13 years
• diagnosed with congenital hemiplegic or children with CP with one more affected side
• apparently disuse phenomenon of the more affected hand at spontaneous contexts
• Participants will be exclude for:
• excessive muscle tone (Modified Ashworth Scale ≤ 2 at any joints of the upper limb) before beginning treatment
• severe cognitive, visual, or auditory disorders according to medical documents, parental reports, and the examiner's clinical observation
• injections of botulinum toxin type A or operations on the UE within 6 months

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Zhongzheng District, 100, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 36987387 DERIVED

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Tien-Ni Wang

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tien-Ni Wang

CONTACT

3366-8163; tnwang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2017
• First Posted: April 25, 2017
• Study Start: June 1, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

TW (1)