Cerebral PalsyNCT03681171
Therapeutic Dance Intervention for Children With Cerebral Palsy
A study testing Therapeutic Dance in people with Cerebral Palsy, run by Shlomit Aizik.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Therapeutic Dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2016to 15 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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.
About this study
Official title: A Pilot Study of a Therapeutic Dance Intervention for Children With Cerebral Palsy
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.
Read the detailed description
Eight children with cerebral palsy (CP), ages 9 to 14 years, participated in a six-week therapeutic ballet intervention. Participants underwent pre- and post-intervention assessments of body composition by dual-energy X-ray absorptiometry (DXA), muscle strength by hand-grip dynamometry, habitual physical activity, gait, selective motor control, and executive function. Follow-up assessments of habitual physical activity, gait, and executive function were completed 4 to 5 weeks after the intervention.
- Conditions
- Cerebral Palsy
- Being tested
- Therapeutic Dance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic DanceOther
Participants attended therapeutic ballet sessions three times per week for six weeks.
| Study group | Role | What they receive |
|---|---|---|
| Children with CP | Experimental | Children with CP (9-15 years old) participated in a therapeutic dance program to improve physical, physiological and cognitive outcomes. Receives: Other: Therapeutic Dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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.
Measured: 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%
Measured: 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.
Measured: 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%
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start6 Oct 2016
- Primary completion15 Jun 2017
- Study completion15 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shlomit Aizik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shlomit Aizik, University of California, Irvine
- Investigators
- Shlomit Aizik, PhD, Study director, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681171
- Sponsor's protocol ID
- 20162682
- Status last verified
- Jan 2025
- First submitted
- 30 Aug 2018
- Last updated
- 12 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31294009
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Therapeutic Dance Intervention for Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03681171
- Acronym / sponsor ID
- 20162682
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Shlomit AizikUniversity, hospital or other
- Study start
- 6 Oct 2016 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 15 Jun 2017 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Posted 12 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Eight children with cerebral palsy (CP), ages 9 to 14 years, participated in a six-week therapeutic ballet intervention. Participants underwent pre- and post-intervention assessments of body composition by dual-energy X-ray absorptiometry (DXA), muscle strength by hand-grip dynamometry, habitual physical activity, gait, selective motor control, and executive function. Follow-up assessments of habitual physical activity, gait, and executive function were completed 4 to 5 weeks after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with CP | Experimental | Other: Therapeutic DanceChildren with CP (9-15 years old) participated in a therapeutic dance program to improve physical, physiological and cognitive outcomes. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic DanceParticipants attended therapeutic ballet sessions three times per week for six weeks. | Other | Children with CP |
Primary outcome
Congruent Trial (Hearts) Accuracy
Time frame: 12 weeks
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%
Congruent Trial (Hearts) Response Time
Time frame: 12 weeks
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.
Incongruent Trial (Flowers) Accuracy
Time frame: 12 weeks
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%
Incongruent Trial (Flowers) Response Time
Time frame: 12 weeks
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.
Mixed Trial (Hearts and Flowers) Accuracy
Time frame: 8 weeks
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%
Mixed Trial (Hearts and Flowers) Response Time
Time frame: 8 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31294009Lakes 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomit Aizik, PhD study director
University of California, Irvine
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Dance in people with Cerebral Palsy, run by Shlomit Aizik.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Congruent Trial (Hearts) Accuracy (time frame: 12 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03681171, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.