Magic Camp for Children With Hemiplegic Cerebral Palsy

NCT03620279 | Completed

• 1 other identifier: IRB-300001044
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children with spastic hemiplegic cerebral palsy (CP). A single group pretest-posttest design (n=10) will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a "Magic Camp" on improving upper limb motor function and health-related quality of life (HRQoL) in children with hemiplegic CP.

Conditions

Cerebral Palsy

Keywords

motor training for cerebral palsy

Outcome Measures

Primary Outcomes (5)

• Unimanual skill as measured by the Jebsen Taylor Test of Hand Function

  Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by occupational therapy (OT) students to assess the efficiency of unimanual grasp and release of items with six tasks. Higher scores (i.e., longer duration the participant takes to complete the task) represent poorer unimanual skills

  baseline

• Bimanual coordination as measured by 3-D kinematic motion analysis

  Participants will be asked to perform the task with their preferred hand choice at a self-selected pace following by an auditory go-signal. Each trial ends when the button is pressed. Five trials will be collected after 2 practice trials, and outcome measures will be averaged over the 5 trials. Longer time duration it takes for the participant to complete the task represents poorer bimanual coordination.

  baseline

• Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)

  CHEQ is a 29-item (parent and child report) questionnaire that evaluates the experience of children in using the more affected hand in activities where usually two hands are required. Percentage use of the more affected hand will be expressed as percentage of independent activities performed bimanually in which the more affected hand is used to stabilize or grip items. Higher percentage (ranging from 0% to 100%) represents higher extent of using the more affected hand.

  Baseline

• Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire

  CPQOL evaluates the well-being of children with CP across several broad domains such as social well-being and acceptance, and emotional well-being. Items are rated on a 9-point scale, and recoded and transformed into scaled scores (transformed to a scale of 1-100) for each domain. An average of the scale scores from all domains (family \& friends, school, communication, health, special equipment, pain and bother, and access to services) is conducted. Higher scores represent better health-related quality of life.

  Baseline

• Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.

  Fingernail samples from every digit will be collected by clipping directly into a Ziploc® bag to avoid losing any parts of the sample. Nail samples will be sent to the Bio-Analytical Redox Biology (BARB) Core Laboratory, University of Alabama at Birmingham (UAB) for analysis.

  Baseline

Secondary Outcomes (9)

• Unimanual skill as measured by the Jebsen Taylor Test of Hand Function

  from baseline to two weeks

• Bimanual coordination as measured by 3-D kinematic motion analysis

  from baseline to two weeks

• Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)

  from baseline to two weeks

• Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire

  from baseline to two weeks

• Unimanual skill as measured by the Jebsen Taylor Test of Hand Function

  from two weeks to three months

Study Arms (1)

Magic camp intervention

EXPERIMENTAL

These children are diagnosed with cerebral palsy and we will provide motor control training.

Behavioral: Magic camp intervention

Interventions

Magic camp intervention BEHAVIORAL

Hand-arm bimanual motor skills training

Magic camp intervention

Eligibility Criteria

• Age: 9 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• spasticity with Modified Ashworth Scale grades between 1 and 3;
• ability to lift the more affected arm 15 cm above a table surface;
• impairment of hand function at levels I to III of the Manual Activity Classification System
• ability to grasp and release light objects with the more affected hand
• largely nonuse of the more affected hand in daily activities as determined by the Pediatric Motor Activity Log
• are interested in learning magic tricks
• have the cognitive and social ability to participate in a camp setting;
• ability to follow directions in English; and
• ability to remember simple sequences of actions to perform magic tricks.

You may not qualify if:

• severe muscle spasticity or fixed contracture in the more affected limb that limits functional arm and hand use
• dystonia
• severe visual or auditory disorders that prevent learning and carrying out the magic tricks
• serious or recurring medical complications
• participation in intensive upper limb intervention and/or musculoskeletal and tone management treatments, dorsal rhizotomy, or surgery on the upper limb in the previous 6 months or anticipated within subsequent 6 months
• start muscle relaxant within the last 3 months; or
• plan to move to another state within the next 6 months.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

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

Study Officials

• Hon K Yuen, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 8, 2018
• Study Start: June 4, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 31, 2018
• Last Updated: February 24, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)