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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03681171
Other study ID # 2016-2682
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 25, 2016
Est. completion date September 2016

Study information

Verified date September 2018
Source University of California, Irvine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender All
Age group 9 Years to 15 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Therapeutic Dance
Participants attended therapeutic ballet sessions three times per week for six weeks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shlomit Aizik

Outcome

Type Measure Description Time frame Safety issue
Primary Gait (GAITRite© system) Assessment before an immediately after six-week therapeutic ballet program and 4-5 weeks post intervention 12 weeks
Primary 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. 12 weeks
Primary 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. 12 weeks
Primary Executive Functions measured by BRIEF (Parent Questionnaire) An 86-item questionnaire 12 weeks
Secondary Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program. Assessment of Lean Body Mass 8 weeks
Secondary Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program. Assessment of Percent Body Fat 8 weeks
Secondary Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program. Assessment of bone density 8 weeks
Secondary Muscle Strength Handgrip (evaluated maximum isometric strength (Kg) before and after six-week therapeutic ballet program. 8 weeks
Secondary CBC Includes hemoglobin measures for anemia and inflammation factors 8 weeks
Secondary Lipid Panel CVD risk factors (lipid screen ) before and after six-week therapeutic ballet program 8 weeks
Secondary 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. 12 weeks
Secondary 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. 8 weeks
Secondary Social and Emotional Functioning measured by Self-Perception Profile for Children Measures Scholastic Competence, Athletic Competence, Social Competence, Physical Appearance, and Behavioral Conduct. 8 weeks
Secondary Social and Emotional Functioning measured by Positive Affect Survey. Measures feelings of pleasurable engagement with the environment (happiness, joy, excitement, engagement). 8 weeks
Secondary Social and Emotional Functioning measured by Perceived Stress Self-Report Scale Asks participants to rate how they have felt over the last month 8 weeks
Secondary Social and Emotional Functioning measured by Strengths and Difficulties Questionnaire (SDQ) SDQ is a brief questionnaire that assesses children's emotional problems 8 weeks
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