NCT04237506

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 24, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2021

Completed
Last Updated

March 18, 2021

Status Verified

March 1, 2021

Enrollment Period

1.8 years

First QC Date

December 31, 2019

Last Update Submit

March 17, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Montreal Stretch Reflex Threshold

    Montreal Stretch Reflex threshold is an objective method using surface electromyography and electrogoniometer to quantify spasticity by measuring the onset of the tonic stretch reflex.

    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 (7)

  • Change in Selective control assessment of the lower extremity (SCALE) Score Sheet

    Tested during assessment sessions to measure change from the baseline at a 10-week period.

  • Change in Pediatric Berg Balance Scale (PBS)

    Tested during assessment sessions to measure change from the baseline at a 10-week period.

  • Change in Dyskinesia impairment scale (DIS)

    Tested during assessment sessions to measure change from the baseline at a 10-week period.

  • Participant Information Questionnaire

    Tested during assessment sessions to measure change from the baseline at a 10-week period.

  • Change in Quality fo Upper Extremity Skills Test (QUEST)

    Tested during assessment sessions to measure change from the baseline at a 10-week period.

  • +2 more secondary outcomes

Study Arms (1)

Intervention group

EXPERIMENTAL

All participants in this group will take the one-hour ballet dance class twice per week for six weeks

Behavioral: Targeted ballet dance

Interventions

The one-hour ballet dance class will be provided twice per week for six weeks. The syllabi are adapted from the Joffrey Ballet Academy and Royal Academy of Dancing that are targeting grades primary to level 1 and typically developing kids at the age of 6 to 10 years old. PI will be the class instructor, and the class structure will follow the guidelines in 'Dance program for physical rehabilitation and participation in children with cerebral palsy' by Lopez-Ortiz et al.

Intervention group

Eligibility Criteria

Age3 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • Not meeting ALL of the criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

Location

Related Publications (10)

  • 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.

    PMID: 25431617BACKGROUND
  • 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.

    PMID: 19220390BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 30350851BACKGROUND
  • 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.

    PMID: 23291508BACKGROUND
  • 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.

    PMID: 27721977BACKGROUND
  • 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.

    PMID: 20298834BACKGROUND
  • 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.

    PMID: 18811701BACKGROUND
  • 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.

    PMID: 27188686BACKGROUND
  • Lopez-Ortiz C, He M, Gaebler-Spira D, Levin MF. Learning ballet technique modulates the stretch reflex in students with cerebral palsy: case series. BMC Neurosci. 2024 Nov 6;25(1):66. doi: 10.1186/s12868-024-00873-0.

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Citlali López-Ortiz, M.A., Ph.D

    University of Illinois at Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Children and adults with cerebral palsy
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 23, 2020

Study Start

January 24, 2017

Primary Completion

November 30, 2018

Study Completion

February 13, 2021

Last Updated

March 18, 2021

Record last verified: 2021-03

Locations