Back to resultsTherapeutic Dance Intervention for Children With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic Dance
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
Inclusion Criteria:
- Cerebral palsy spastic diplegia and/or hemiplegia
- Absence of health problems that would preclude participation in exercise
- Male or female age 9 - 15 years inclusive at the time of consent
- Minimum level of intellectual functioning (e.g., as determined by an IQ score of 80 or above or other education placement and testing indicating sufficient understanding)
- Ability to complete study measures at the assessment
- Ability to participate in dance classes conducted in English
- Interest in learning ballet
- Intact vision
- Intact hearing
- Able to ambulate independently in the community with or without a device
- Intact proprioception in lower extremities
- Able to complete assessment measures and consents in English
- Referral from the child's pediatrician or other physician indicating that the child is physically able to participate in an exercise intervention
Exclusion Criteria:
- Children with a current diagnosis of severe Major Depressive Disorder
- Generalized Anxiety Disorder
- Epilepsy
- Autism
- Other major medical conditions that prohibit full participation and children with severe developmental disorders (e.g., mental retardation, severe autism) or with physical impairments that prohibit full participation were excluded from the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children with CP
Arm Description
Children with CP (9-15 years old) participated in a therapeutic dance program to improve physical, physiological and cognitive outcomes.
Outcomes
Primary Outcome Measures
Gait (GAITRite© system)
Assessment before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention
Executive Functions measured by Hearts and Flowers Flanker Tasks
Measures attention and working memory before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
Executive Functions measured by Stroop Colored Word Test
Measures inhibitory control before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
Executive Functions measured by BRIEF (Parent Questionnaire)
An 86-item questionnaire
Secondary Outcome Measures
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Assessment of Lean Body Mass
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Assessment of Percent Body Fat
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Assessment of bone density
Muscle Strength
Handgrip (evaluated maximum isometric strength (Kg) before and after six-week therapeutic ballet program.
CBC
Includes hemoglobin measures for anemia and inflammation factors
Lipid Panel
CVD risk factors (lipid screen ) before and after six-week therapeutic ballet program
Habitual Physical Activity assessment
Physical activity was measured using ActiGraph accelerometers before and immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
Social and Emotional Functioning measured by Self-Efficacy Survey (Child)
Measures individual perceptions of one's capacity to manage one's functioning and control over events before and after six-week therapeutic ballet program.
Social and Emotional Functioning measured by Self-Perception Profile for Children
Measures Scholastic Competence, Athletic Competence, Social Competence, Physical Appearance, and Behavioral Conduct.
Social and Emotional Functioning measured by Positive Affect Survey.
Measures feelings of pleasurable engagement with the environment (happiness, joy, excitement, engagement).
Social and Emotional Functioning measured by Perceived Stress Self-Report Scale
Asks participants to rate how they have felt over the last month
Social and Emotional Functioning measured by Strengths and Difficulties Questionnaire (SDQ)
SDQ is a brief questionnaire that assesses children's emotional problems
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03681171
Brief Title
Therapeutic Dance Intervention for Children With Cerebral Palsy
Official Title
A Pilot Study of a Therapeutic Dance Intervention for Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 25, 2016 (Actual)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Shlomit Aizik
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Children with cerebral palsy (CP) have motor impairments that make it challenging for them to participate in standard physical activity (PA) programs. There is a need to evaluate adapted PA programs for this population. Dance can promote coordination, posture, muscle strength, motor learning, and executive functioning. This pilot study evaluated the feasibility and the effects of a new therapeutic ballet intervention specifically designed for children with CP on physiological and executive functions outcomes.
Detailed Description
8 children with CP (9-14y/o; 75% female) participated in a six-week therapeutic ballet program. Participants had body composition (DXA), muscle strength (hand-grip dynamometer), habitual physical activity, gait and selective motor control functions, and executive function tasks before and after the intervention. Follow-up assessments of habitual physical activity, gait and executive functions were completed four to five week post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Children with CP
Arm Type
Experimental
Arm Description
Children with CP (9-15 years old) participated in a therapeutic dance program to improve physical, physiological and cognitive outcomes.
Intervention Type
Other
Intervention Name(s)
Therapeutic Dance
Intervention Description
Participants attended therapeutic ballet sessions three times per week for six weeks.
Primary Outcome Measure Information:
Title
Gait (GAITRite© system)
Description
Assessment before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention
Time Frame
12 weeks
Title
Executive Functions measured by Hearts and Flowers Flanker Tasks
Description
Measures attention and working memory before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
Time Frame
12 weeks
Title
Executive Functions measured by Stroop Colored Word Test
Description
Measures inhibitory control before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
Time Frame
12 weeks
Title
Executive Functions measured by BRIEF (Parent Questionnaire)
Description
An 86-item questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Description
Assessment of Lean Body Mass
Time Frame
8 weeks
Title
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Description
Assessment of Percent Body Fat
Time Frame
8 weeks
Title
Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
Description
Assessment of bone density
Time Frame
8 weeks
Title
Muscle Strength
Description
Handgrip (evaluated maximum isometric strength (Kg) before and after six-week therapeutic ballet program.
Time Frame
8 weeks
Title
CBC
Description
Includes hemoglobin measures for anemia and inflammation factors
Time Frame
8 weeks
Title
Lipid Panel
Description
CVD risk factors (lipid screen ) before and after six-week therapeutic ballet program
Time Frame
8 weeks
Title
Habitual Physical Activity assessment
Description
Physical activity was measured using ActiGraph accelerometers before and immediately after six-week therapeutic ballet program and 4-5 weeks post intervention.
Time Frame
12 weeks
Title
Social and Emotional Functioning measured by Self-Efficacy Survey (Child)
Description
Measures individual perceptions of one's capacity to manage one's functioning and control over events before and after six-week therapeutic ballet program.
Time Frame
8 weeks
Title
Social and Emotional Functioning measured by Self-Perception Profile for Children
Description
Measures Scholastic Competence, Athletic Competence, Social Competence, Physical Appearance, and Behavioral Conduct.
Time Frame
8 weeks
Title
Social and Emotional Functioning measured by Positive Affect Survey.
Description
Measures feelings of pleasurable engagement with the environment (happiness, joy, excitement, engagement).
Time Frame
8 weeks
Title
Social and Emotional Functioning measured by Perceived Stress Self-Report Scale
Description
Asks participants to rate how they have felt over the last month
Time Frame
8 weeks
Title
Social and Emotional Functioning measured by Strengths and Difficulties Questionnaire (SDQ)
Description
SDQ is a brief questionnaire that assesses children's emotional problems
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cerebral palsy spastic diplegia and/or hemiplegia
Absence of health problems that would preclude participation in exercise
Male or female age 9 - 15 years inclusive at the time of consent
Minimum level of intellectual functioning (e.g., as determined by an IQ score of 80 or above or other education placement and testing indicating sufficient understanding)
Ability to complete study measures at the assessment
Ability to participate in dance classes conducted in English
Interest in learning ballet
Intact vision
Intact hearing
Able to ambulate independently in the community with or without a device
Intact proprioception in lower extremities
Able to complete assessment measures and consents in English
Referral from the child's pediatrician or other physician indicating that the child is physically able to participate in an exercise intervention
Exclusion Criteria:
Children with a current diagnosis of severe Major Depressive Disorder
Generalized Anxiety Disorder
Epilepsy
Autism
Other major medical conditions that prohibit full participation and children with severe developmental disorders (e.g., mental retardation, severe autism) or with physical impairments that prohibit full participation were excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shlomit Aizik, PhD
Organizational Affiliation
University of California, Irvine
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
31294009
Citation
Lakes KD, Sharp K, Grant-Beuttler M, Neville R, Haddad F, Sunico R, Ho D, Schneider M, Sawitz S, Paulsen J, Caputo K, Lu KD, Aminian A, Lopez-Ortiz C, Radom-Aizik S. A Six Week Therapeutic Ballet Intervention Improved Gait and Inhibitory Control in Children With Cerebral Palsy-A Pilot Study. Front Public Health. 2019 Jun 25;7:137. doi: 10.3389/fpubh.2019.00137. eCollection 2019.
Results Reference
derived
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Therapeutic Dance Intervention for Children With Cerebral Palsy
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