Clinical trial NCT03620279: Magic Camp for Children With Hemiplegic Cerebral Palsy
Official title: Magic Camp for Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: motor training for cerebral palsy
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 7
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This project will employ a single group pretest-posttest design to investigate the impact of a "Magic Camp" on the improvement in upper limb motor function, health-related quality of life, and emotional stress among children with spastic hemiplegic CP. After the baseline evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per day for 2 consecutive weeks. The primary outcome measures will be unimanual function as measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by kinematic parameters using motion analysis, and spontaneous use of the more affected limb in real-life activities that demand the use of both hands as measured by the Children's Hand Experience Questionnaire. Secondary outcome measures will include HRQoL as measured by the Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the caregivers and children, and emotional stress as measured by the fingernail cortisol levels.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
timeFrame: baseline
measure: Bimanual coordination as measured by 3-D kinematic motion analysis
timeFrame: baseline
measure: Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
timeFrame: Baseline
measure: Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
timeFrame: Baseline
measure: Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
timeFrame: Baseline
Secondary outcomes:
measure: Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
timeFrame: from baseline to two weeks
measure: Bimanual coordination as measured by 3-D kinematic motion analysis
timeFrame: from baseline to two weeks
measure: Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
timeFrame: from baseline to two weeks
measure: Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
timeFrame: from baseline to two weeks
measure: Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
timeFrame: from two weeks to three months
measure: Bimanual coordination as measured by 3-D kinematic motion analysis
timeFrame: from two weeks to three months
measure: Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
timeFrame: from two weeks to three months
measure: Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
timeFrame: from two weeks to three months
measure: Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
timeFrame: from baseline to three months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Hon K Yuen, PhD
role: PRINCIPAL_INVESTIGATOR
References: