Clinical trial NCT04237506: Targeted Ballet Class for Cerebral Palsy
Official title: Targeted Ballet Class for Increased Range of Motion and Stretch Reflex Regulation in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2020-01-23
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Children and adults with cerebral palsy
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of the targeted ballet dance on participants with cerebral palsy

Detailed description: Cerebral palsy (CP) is the most common motor disorder in childhood, with a prevalence of 3.1 to 3.6 cases per 1000 living births in the United States. The motor signs of CP include abnormal muscle tone and motor control, preventing individuals with CP from participating in normal daily activity. The most common type of CP is spastic CP, in which spasticity is present and range of motion in the joints is reduced. Physical therapy is one fundamental method of rehabilitation that attempts to recover motor function via exercises, while the effects of physical therapy are still elusive due to the lack of comprehensive evidence. This study uses a targeted ballet class to promote balance, increased range of motion, and reduced spasticity. The combination of qualitative clinical measures and quantitative assessment spasticity aims to demonstrate the benefits brought by the dance class.

Eligibility criteria: Inclusion Criteria:

* diagnosed with spastic cerebral palsy
* is between 3 to 64 years old
* have no uncorrected vision
* have no other neuromuscular or musculoskeletal condition
* have not had surgical procedures within six months of enrollment in the study
* participate in stable school and/or private physical therapy with a frequency no greater than one session per week
* have no changes in medication for the last six months
* have the ability to pay attention and follow three-step directions
* be medically stable, (8) have no other concurrent illness
* have not received any Botox treatment within three months previous to the initiation of the study, and have Gross Motor System Classification Scale (GMFCS) I-IV (NOT V).

Exclusion Criteria:

* Not meeting ALL of the criteria

Primary outcomes:
measure: Change in Montreal Stretch Reflex Threshold
timeFrame: Tested during assessment sessions and on the first and last week of dance to evaluate change from the baseline at a 10-week period.
Secondary outcomes:
measure: Change in Selective control assessment of the lower extremity (SCALE) Score Sheet
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
measure: Change in Pediatric Berg Balance Scale (PBS)
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
measure: Change in Dyskinesia impairment scale (DIS)
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
measure: Participant Information Questionnaire
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
measure: Change in Quality fo Upper Extremity Skills Test (QUEST)
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
measure: Change in Gross Motor Function Classification Scale
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
measure: Change in Modified Tardieu Scale
timeFrame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Citlali López-Ortiz, M.A., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez-Ortiz C, Gladden K, Deon L, Schmidt J, Girolami G, Gaebler-Spira D. Dance program for physical rehabilitation and participation in children with cerebral palsy. Arts Health. 2012 Feb 1;4(1):39-54. doi: 10.1080/17533015.2011.564193. Epub 2011 Jun 13.
citation: Fowler EG, Staudt LA, Greenberg MB, Oppenheim WL. Selective Control Assessment of the Lower Extremity (SCALE): development, validation, and interrater reliability of a clinical tool for patients with cerebral palsy. Dev Med Child Neurol. 2009 Aug;51(8):607-14. doi: 10.1111/j.1469-8749.2008.03186.x. Epub 2009 Feb 12.
citation: Rodrigues, Marcos & Levin, Mindy & Feldman, Anatol & Mullick, Aditi. (2014). A New Standard in Objective Measurement of Spasticity. Journal of Medical Devices. 7. 10.1115/1.4024488.
citation: Lopez-Ortiz C, Gaebler-Spira DJ, Mckeeman SN, Mcnish RN, Green D. Dance and rehabilitation in cerebral palsy: a systematic search and review. Dev Med Child Neurol. 2019 Apr;61(4):393-398. doi: 10.1111/dmcn.14064. Epub 2018 Oct 23.
citation: Chen CL, Shen IH, Chen CY, Wu CY, Liu WY, Chung CY. Validity, responsiveness, minimal detectable change, and minimal clinically important change of Pediatric Balance Scale in children with cerebral palsy. Res Dev Disabil. 2013 Mar;34(3):916-22. doi: 10.1016/j.ridd.2012.11.006. Epub 2013 Jan 3.
citation: Lopez-Ortiz C, Egan T, Gaebler-Spira DJ. Pilot study of a targeted dance class for physical rehabilitation in children with cerebral palsy. SAGE Open Med. 2016 Sep 23;4:2050312116670926. doi: 10.1177/2050312116670926. eCollection 2016.
citation: Gracies JM, Burke K, Clegg NJ, Browne R, Rushing C, Fehlings D, Matthews D, Tilton A, Delgado MR. Reliability of the Tardieu Scale for assessing spasticity in children with cerebral palsy. Arch Phys Med Rehabil. 2010 Mar;91(3):421-8. doi: 10.1016/j.apmr.2009.11.017.
citation: Klingels K, De Cock P, Desloovere K, Huenaerts C, Molenaers G, Van Nuland I, Huysmans A, Feys H. Comparison of the Melbourne Assessment of Unilateral Upper Limb Function and the Quality of Upper Extremity Skills Test in hemiplegic CP. Dev Med Child Neurol. 2008 Dec;50(12):904-9. doi: 10.1111/j.1469-8749.2008.03123.x. Epub 2008 Sep 20.
citation: Graham HK, Rosenbaum P, Paneth N, Dan B, Lin JP, Damiano DL, Becher JG, Gaebler-Spira D, Colver A, Reddihough DS, Crompton KE, Lieber RL. Cerebral palsy. Nat Rev Dis Primers. 2016 Jan 7;2:15082. doi: 10.1038/nrdp.2015.82.