Magic Camp for Children With Hemiplegic Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magic camp intervention
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring motor training for cerebral palsy
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.
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Magic camp intervention
Arm Description
These children are diagnosed with cerebral palsy and we will provide motor control training.
Outcomes
Primary Outcome Measures
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
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.
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.
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.
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.
Secondary Outcome Measures
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 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.
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.
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.
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 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.
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 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.
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.
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.
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 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.
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 BARB Core Laboratory, UAB for analysis.
Full Information
NCT ID
NCT03620279
First Posted
August 2, 2018
Last Updated
February 20, 2020
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03620279
Brief Title
Magic Camp for Children With Hemiplegic Cerebral Palsy
Official Title
Magic Camp for Children With Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
October 1, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
motor training for cerebral palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magic camp intervention
Arm Type
Experimental
Arm Description
These children are diagnosed with cerebral palsy and we will provide motor control training.
Intervention Type
Behavioral
Intervention Name(s)
Magic camp intervention
Intervention Description
Hand-arm bimanual motor skills training
Primary Outcome Measure Information:
Title
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Description
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
Time Frame
baseline
Title
Bimanual coordination as measured by 3-D kinematic motion analysis
Description
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.
Time Frame
baseline
Title
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Description
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.
Time Frame
Baseline
Title
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Description
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.
Time Frame
Baseline
Title
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Description
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.
Time Frame
from baseline to two weeks
Title
Bimanual coordination as measured by 3-D kinematic motion analysis
Description
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.
Time Frame
from baseline to two weeks
Title
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Description
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.
Time Frame
from baseline to two weeks
Title
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Description
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.
Time Frame
from baseline to two weeks
Title
Unimanual skill as measured by the Jebsen Taylor Test of Hand Function
Description
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.
Time Frame
from two weeks to three months
Title
Bimanual coordination as measured by 3-D kinematic motion analysis
Description
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.
Time Frame
from two weeks to three months
Title
Extent of the more affected hand use in daily bimanual activities as measured by the Children's Hand Experience Questionnaire (CHEQ)
Description
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.
Time Frame
from two weeks to three months
Title
Health-related quality of life as measured by the Cerebral Palsy Quality of Life (CPQOL) Questionnaire
Description
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.
Time Frame
from two weeks to three months
Title
Emotional stress as measured by the amount of cortisol in participants' and their caregivers' fingernails.
Description
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.
Time Frame
from baseline to three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hon K Yuen, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Magic Camp for Children With Hemiplegic Cerebral Palsy
We'll reach out to this number within 24 hrs