NCT03681171

Brief Summary

Children with cerebral palsy (CP) have motor impairments that may limit participation in standard physical activity (PA) programs. Adapted PA interventions may help address this gap. Dance-based interventions may support coordination, posture, muscle strength, motor learning, and executive function. This pilot study evaluates the feasibility and preliminary effects of a therapeutic ballet intervention designed for children with CP on physiological and executive function outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 6, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 21, 2018

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

March 12, 2026

Completed
Last Updated

March 12, 2026

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

August 30, 2018

Results QC Date

August 14, 2024

Last Update Submit

March 11, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Congruent Trial (Hearts) Accuracy

    Inhibitory control, working memory, and cognitive flexibility (hearts and flowers computer task) The scale title is Accuracy (%) and the measurement is percent correct, where the higher scores mean better results and more accuracy. Accuracy ranges from about 20%-100%

    12 weeks

  • Congruent Trial (Hearts) Response Time

    Inhibitory control, working memory, and cognitive flexibility (hearts and flowers computer task) The scale title is Response Time in milliseconds (ms), the lower the number the better the score. The range is about 550ms-1100ms.

    12 weeks

  • Incongruent Trial (Flowers) Accuracy

    Inhibitory control, working memory, and cognitive flexibility (hearts and flowers computer task) The scale title is Accuracy (%) and the measurement is percent correct, where the higher scores mean better results and more accuracy. Accuracy ranges from about 20%-100%

    12 weeks

  • Incongruent Trial (Flowers) Response Time

    Inhibitory control, working memory, and cognitive flexibility (hearts and flowers computer task) The scale title is Response Time in milliseconds (ms), the lower the number the better the score. The range is about 550ms-1100ms.

    12 weeks

  • Mixed Trial (Hearts and Flowers) Accuracy

    Inhibitory control, working memory, and cognitive flexibility (hearts and flowers computer task) The scale title is Accuracy (%) and the measurement is percent correct, where the higher scores mean better results and more accuracy. Accuracy ranges from about 20%-100%

    8 weeks

  • Mixed Trial (Hearts and Flowers) Response Time

    Inhibitory control, working memory, and cognitive flexibility (hearts and flowers computer task) The scale title is Response Time in milliseconds (ms), the lower the number the better the score. The range is about 550ms-1100ms.

    8 weeks

Study Arms (1)

Children with CP

EXPERIMENTAL

Children with CP (9-15 years old) participated in a therapeutic dance program to improve physical, physiological and cognitive outcomes.

Other: Therapeutic Dance

Interventions

Participants attended therapeutic ballet sessions three times per week for six weeks.

Children with CP

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

Modifications to the intervention might be needed on individualized basis to optimize health benefits, particularly for those with a greater level of initial impairment.

Results Point of Contact

Title
Dr. Peter Horvath (Administrative Contact)
Organization
University of California, Irvine Pediatric Exercise and Genomics Research Center (PERC)

Study Officials

  • Shlomit Aizik, PhD

    University of California, Irvine

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2018

First Posted

September 21, 2018

Study Start

October 6, 2016

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

March 12, 2026

Results First Posted

March 12, 2026

Record last verified: 2025-01