Cerebral Palsy Clinical Trial
Official title:
A Pilot Study of a Therapeutic Dance Intervention for Children With Cerebral Palsy
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 |
Verified date | September 2018 |
Source | University of California, Irvine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Shlomit Aizik |
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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