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The Impact of a Virtual Magic Trick Training Program

Primary Purpose

Cerebral Palsy, Hemiplegic Cerebral Palsy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
magic trick training
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Confirmed diagnosis (with proof of evidence) of UCP; Aged between 12 and 18 years (younger children may lack the inductive reasoning skills to learn magic tricks); Functional ability of the affected hand between levels I and III of the Manual Activity Classification System; Intact cognition as indicated by a score above the corresponding cut-off point of the child's age on the Mini-Mental Examination for Children; and Access to internet and a computer or smartphone that can perform videoconferencing. Exclusion Criteria: Severe hearing or visual impairments that prevent online learning; Previous participation in organized magic learning program or camp; Current or planned participation in an intensive upper limb intervention and/or new spasticity management (e.g., starting/increasing muscle relaxants, Botox injections) during the study period; or Current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

magic trick training

waitlist control

Arm Description

Participation in a 6 weekly virtual magic trick training camp with three lessons per week.

Participation in usual daily activities.

Outcomes

Primary Outcome Measures

Children's HandExperience Questionnaire (CHEQ)
The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome.
Children's HandExperience Questionnaire (CHEQ)
The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome.
Children's HandExperience Questionnaire (CHEQ)
The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome.
Social Skills Improvement System (SSIS)
The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills.
Social Skills Improvement System (SSIS)
The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills.
Social Skills Improvement System (SSIS)
The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills.
Strengths and Difficulties Questionnaire (SDQ)
SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.
Strengths and Difficulties Questionnaire (SDQ)
SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.
Strengths and Difficulties Questionnaire (SDQ)
SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.
Rosenberg Self Esteem Scale (RSES)
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
Rosenberg Self Esteem Scale (RSES)
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
Rosenberg Self Esteem Scale (RSES)
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
Dimensional Mastery Questionnaire (DMQ)
DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation.
Dimensional Mastery Questionnaire (DMQ)
DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation.
Dimensional Mastery Questionnaire (DMQ)
DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation.
Self-efficacy Questionnaire for Children
It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.
Self-efficacy Questionnaire for Children
It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.
Self-efficacy Questionnaire for Children
It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.

Secondary Outcome Measures

Emotional stress
the amount of cortisol in participants' hair.
Emotional stress
the amount of cortisol in participants' hair.
Emotional stress
the amount of cortisol in participants' hair.

Full Information

First Posted
December 5, 2022
Last Updated
March 29, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05664841
Brief Title
The Impact of a Virtual Magic Trick Training Program
Official Title
The Impact of a Virtual Magic Trick Training Program on Social Emotional Functioning in Adolescents With Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 27, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

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 project will attempt to confirm the benefits of a structured magic trick training program (MTTP) experience in adolescents with unilateral cerebral palsy. Benefits of participating in a 6-week virtual MTTP will be evaluated using validated assessments to measure the extent to which adolescents use two hands in activities and improve in social-emotional competencies.
Detailed Description
The proposed study will employ a RCT to test the two hypotheses. The design of the MTTP is based on the SELframework. The study will incorporate a 2 x 3 two-way factorial design with repeated measures at three time points.The two between-subject factor conditions will be participation in a MTTP versus a waitlist control condition that willbe evaluated at baseline, immediately post-program, and at 6-week follow-up (within-subject factor conditions). Sixty adolescents with UCP will be recruited for this study. Aim 1. Evaluate the therapeutic benefits of a 6-week virtual MTTP on the extent of two-handed use tocomplete daily activities, social-emotional functioning, and emotional stress among adolescents with UCP. Hypothesis #1: Adolescents with UCP who participate in a virtual MTTP will demonstrate increased use of two handsto perform daily activities, better social-emotional functioning, and a reduction in emotional stress compared to waitlistcontrols at the conclusion of a 6-week MTTP. Hypothesis #2: The positive impact of the virtual MTTP on the participants' improved number of activities performedusing two hands, social-emotional functioning, and reduction in emotional stress will be maintained at 6-week follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hemiplegic Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
magic trick training
Arm Type
Experimental
Arm Description
Participation in a 6 weekly virtual magic trick training camp with three lessons per week.
Arm Title
waitlist control
Arm Type
No Intervention
Arm Description
Participation in usual daily activities.
Intervention Type
Behavioral
Intervention Name(s)
magic trick training
Intervention Description
A typical session will begin with the magician demonstrating a magic trick then revealing the secret move of the trick.The participants will learn and practice each trick. With assistance from the magician, participants will develop an oralstory presentation for the trick. After participants master one trick, the magician will demonstrate and teach the next.
Primary Outcome Measure Information:
Title
Children's HandExperience Questionnaire (CHEQ)
Description
The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome.
Time Frame
baseline
Title
Children's HandExperience Questionnaire (CHEQ)
Description
The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome.
Time Frame
at 6 week
Title
Children's HandExperience Questionnaire (CHEQ)
Description
The CHEQ 2.0 evaluates the extent of participants in using their affected hand. Participants are asked to indicate how they normally perform 27 daily activities where two hands are usually required, i.e. did they typically use one hand, use two hands, or with help. Participants respond verbally to each of the 27 activity statements. The number of activities in which the participant used two hands is the outcome.
Time Frame
at 12 week
Title
Social Skills Improvement System (SSIS)
Description
The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills.
Time Frame
baseline
Title
Social Skills Improvement System (SSIS)
Description
The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills.
Time Frame
at 6 week
Title
Social Skills Improvement System (SSIS)
Description
The Social Skills scale of the SSIS consists of seven subscales: Communication, Cooperation, Assertion, Responsibility, Empathy, Engagement, and Self-control. The social skills scale has 46 items rated on a 4-point Likert-type scale (0 = not true, 3 = very true) with higher scores representing better social skills.
Time Frame
at 12 week
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.
Time Frame
baseline
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.
Time Frame
at 6 week
Title
Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ (peer problem scale and prosocial scale) consists of 10 items rated on a 3-point Likert-type scale (not true=1 to certainly true=3), with higher scores indicating higher psychological problems. Some items require reverse scoring.
Time Frame
at 12 week
Title
Rosenberg Self Esteem Scale (RSES)
Description
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
Time Frame
baseline
Title
Rosenberg Self Esteem Scale (RSES)
Description
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
Time Frame
at 6 week
Title
Rosenberg Self Esteem Scale (RSES)
Description
RSES consists of 10 items rated on a 4-point Likert-type scale, with higher scores indicate higher self-esteem.
Time Frame
at 12 week
Title
Dimensional Mastery Questionnaire (DMQ)
Description
DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation.
Time Frame
baseline
Title
Dimensional Mastery Questionnaire (DMQ)
Description
DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation.
Time Frame
at 6 week
Title
Dimensional Mastery Questionnaire (DMQ)
Description
DMS consists of 41 items rated on a 5-point Likert-type scale (not like me/my child=1 to exactly like me/my child=5) with higher scores representing strong mastery motivation.
Time Frame
at 12 week
Title
Self-efficacy Questionnaire for Children
Description
It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.
Time Frame
baseline
Title
Self-efficacy Questionnaire for Children
Description
It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.
Time Frame
at 6 week
Title
Self-efficacy Questionnaire for Children
Description
It consists of 16 items rated on a 5-point Likert-type scale (not at all=1 to very well=5) with higher scores indicating higher self-efficacy.
Time Frame
at 12 week
Secondary Outcome Measure Information:
Title
Emotional stress
Description
the amount of cortisol in participants' hair.
Time Frame
baseline
Title
Emotional stress
Description
the amount of cortisol in participants' hair.
Time Frame
at 6 week
Title
Emotional stress
Description
the amount of cortisol in participants' hair.
Time Frame
at 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Confirmed diagnosis (with proof of evidence) of UCP; Aged between 12 and 18 years (younger children may lack the inductive reasoning skills to learn magic tricks); Functional ability of the affected hand between levels I and III of the Manual Activity Classification System; Intact cognition as indicated by a score above the corresponding cut-off point of the child's age on the Mini-Mental Examination for Children; and Access to internet and a computer or smartphone that can perform videoconferencing. Exclusion Criteria: Severe hearing or visual impairments that prevent online learning; Previous participation in organized magic learning program or camp; Current or planned participation in an intensive upper limb intervention and/or new spasticity management (e.g., starting/increasing muscle relaxants, Botox injections) during the study period; or Current or planned participation in psychological therapy or a clinical trial during the study period that could affect the outcomes of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hon Yuen
Phone
205-934-6301
Email
yuen@uab.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Kirklin
Phone
205-934-0862
Email
kkirklin@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hon 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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hon K Yuen, PhD
First Name & Middle Initial & Last Name & Degree
Hon K Yuen, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33728284
Citation
Spencer K, Yuen HK, Jenkins GR, Kirklin K, Vogtle LK, Davis D. The 'magic' of magic camp from the perspective of children with hemiparesis. J Exerc Rehabil. 2021 Feb 23;17(1):15-20. doi: 10.12965/jer.2040802.401. eCollection 2021 Feb.
Results Reference
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The Impact of a Virtual Magic Trick Training Program

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