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Magic Camp for Children With Hemiplegic Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT03620279
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Hon K. Yuen, PhD, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Behavioral: Magic camp intervention Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magic Camp for Children With Hemiplegic Cerebral Palsy
Actual Study Start Date : June 4, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Magic camp intervention
These children are diagnosed with cerebral palsy and we will provide motor control training.
Behavioral: Magic camp intervention
Hand-arm bimanual motor skills training




Primary Outcome Measures :
  1. Unimanual skill as measured by the Jebsen Taylor Test of Hand Function [ Time Frame: baseline ]
    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

  2. Bimanual coordination as measured by 3-D kinematic motion analysis [ Time Frame: baseline ]
    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.

  3. Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ) [ Time Frame: Baseline ]
    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.

  4. Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire [ Time Frame: Baseline ]
    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.

  5. Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails. [ Time Frame: Baseline ]
    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.


Secondary Outcome Measures :
  1. Unimanual skill as measured by the Jebsen Taylor Test of Hand Function [ Time Frame: from baseline to two weeks ]
    Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by 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.

  2. Bimanual coordination as measured by 3-D kinematic motion analysis [ Time Frame: from baseline to two weeks ]
    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.

  3. Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ) [ Time Frame: from baseline to two weeks ]
    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.

  4. Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire [ Time Frame: from baseline to two weeks ]
    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 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.

  5. Unimanual skill as measured by the Jebsen Taylor Test of Hand Function [ Time Frame: from two weeks to three months ]
    Jebsen Taylor Test of Hand Function (JTTHF) is a standardized timed test administered by 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.

  6. Bimanual coordination as measured by 3-D kinematic motion analysis [ Time Frame: from two weeks to three months ]
    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.

  7. Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ) [ Time Frame: from two weeks to three months ]
    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.

  8. Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire [ Time Frame: from two weeks to three months ]
    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 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.

  9. Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails. [ Time Frame: from baseline to three months ]
    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 BARB Core Laboratory, UAB for analysis.



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Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03620279


Contacts
Contact: Hon K Yuen, PhD 205-934-6301 yuen@uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Hon K Yuen, PhD         
Principal Investigator: Hon K Yuen, PhD         
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Principal Investigator: Hon K Yuen, PhD University of Alabama at Birmingham

Responsible Party: Hon K. Yuen, PhD, principal investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03620279     History of Changes
Other Study ID Numbers: IRB-300001044
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hon K. Yuen, PhD, University of Alabama at Birmingham:
motor training for cerebral palsy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases