Clinical trial NCT03681171: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 9
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Gait (GAITRite© system)
timeFrame: 12 weeks
measure: Executive Functions measured by Hearts and Flowers Flanker Tasks
timeFrame: 12 weeks
measure: Executive Functions measured by Stroop Colored Word Test
timeFrame: 12 weeks
measure: Executive Functions measured by BRIEF (Parent Questionnaire)
timeFrame: 12 weeks
Secondary outcomes:
measure: Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
timeFrame: 8 weeks
measure: Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
timeFrame: 8 weeks
measure: Body Composition Dual X-ray Absorptiometry, DXA scan before and after six-week therapeutic ballet program.
timeFrame: 8 weeks
measure: Muscle Strength
timeFrame: 8 weeks
measure: CBC
timeFrame: 8 weeks
measure: Lipid Panel
timeFrame: 8 weeks
measure: Habitual Physical Activity assessment
timeFrame: 12 weeks
measure: Social and Emotional Functioning measured by Self-Efficacy Survey (Child)
timeFrame: 8 weeks
measure: Social and Emotional Functioning measured by Self-Perception Profile for Children
timeFrame: 8 weeks
measure: Social and Emotional Functioning measured by Positive Affect Survey.
timeFrame: 8 weeks
measure: Social and Emotional Functioning measured by Perceived Stress Self-Report Scale
timeFrame: 8 weeks
measure: Social and Emotional Functioning measured by Strengths and Difficulties Questionnaire (SDQ)
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Irvine
name: Shlomit Aizik, PhD
role: STUDY_DIRECTOR
References:
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.