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Targeted Ballet Class for Cerebral Palsy (TBCCP)

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Targeted ballet dance
Sponsored by
Citlali Lopez-Ortiz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

3 Years - 64 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Illinois at Urbana-Champaign

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Selective control assessment of the lower extremity (SCALE) Score Sheet
Selective control assessment of the lower extremity (SCALE) evaluates the ability to perform isolated movements at one joint without activation of other joints or flexor/extensor patterns. It has been shown to have high interrater reliability. SCALE scores the isolated movement at five joints of one lower limb, including hip, knee, foot/subtalar joint, ankle and toe. For each joint, the movement is rated on a scale of 0 to 2 that a score of 0 indicates inability to perform the action and a score of 2 indicates normal movement. The scores are summed to obtain a total score for that limb (the maximum score is 10), and a high score indicates a better capacity of selectively controlling movements of the joint.
Change in Pediatric Berg Balance Scale (PBS)
It assesses balance function in children and has been shown to have good reliability and validity. It has 14 items and each item is scored on a scale of 0 to 4 that a score of 4 indicates the ability to perform the task with minimal or no assistance. The total score is obtained by adding individual scores of each item together, and a higher score indicates better balance function.
Change in Dyskinesia impairment scale (DIS)
It has two subscales, dystonia and choreoathetosis, and is used to assess the severity of dystonia and choreoathetosis during activity or rest. It has been shown to have good to excellent reliability and validity. In each subscale, the score is rated on a scale of 0 to 4 for both duration and amplitude of each criterion that a score of 0 indicate normal movement and a score of 4 indicates that the motor symptom is always present. The scores will be added together to obtain two subscores, and the total score is the sum of subscores (the highest possible score is 576) and the higher the total score is, the more severs the dystonia or choreoathetosis will be.
Participant Information Questionnaire
Questionnaire on health status and demographic information
Change in Quality fo Upper Extremity Skills Test (QUEST)
It has 36 items that evaluate the upper and hand functions with excellent test reliability. The score of each item ranges from -1 to 2. A score of 2 indicates the ability to complete actions as requested, a score of 1 indicate being unable or unwilling to complete actions, or unable to administer the item. A score of -1 is given when abnormal movement is present in the posture section. Initial scores are obtained by adding scores from each section, and these initial scores is standardized to get the total score which ranges from 0 to 100. The higher the score, the better upper limb function will be.
Change in Gross Motor Function Classification Scale
It evaluates gross motor function with 5 levels with level 5 being the most impaired that requires assistance at all settings (at home, school, outdoors and in the community).
Change in Modified Tardieu Scale
It evaluates spasticity by measuring the angle of catch and range of motion. Angle of catch is the joint angle at which there is a resistance of muscle when it is passively stretched at different speeds, and range of motion is the range a joint can achieve when the muscle is stretched at a very slow speed. Scores range from 0 to 5. A score of 0 means no resistance of the muscle during the passive movement and a score of 5 indicate the joint immobility.

Full Information

First Posted
December 31, 2019
Last Updated
March 17, 2021
Sponsor
Citlali Lopez-Ortiz
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1. Study Identification

Unique Protocol Identification Number
NCT04237506
Brief Title
Targeted Ballet Class for Cerebral Palsy
Acronym
TBCCP
Official Title
Targeted Ballet Class for Increased Range of Motion and Stretch Reflex Regulation in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
February 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Citlali Lopez-Ortiz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Children and adults with cerebral palsy
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
All participants in this group will take the one-hour ballet dance class twice per week for six weeks
Intervention Type
Behavioral
Intervention Name(s)
Targeted ballet dance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Montreal Stretch Reflex Threshold
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in Selective control assessment of the lower extremity (SCALE) Score Sheet
Description
Selective control assessment of the lower extremity (SCALE) evaluates the ability to perform isolated movements at one joint without activation of other joints or flexor/extensor patterns. It has been shown to have high interrater reliability. SCALE scores the isolated movement at five joints of one lower limb, including hip, knee, foot/subtalar joint, ankle and toe. For each joint, the movement is rated on a scale of 0 to 2 that a score of 0 indicates inability to perform the action and a score of 2 indicates normal movement. The scores are summed to obtain a total score for that limb (the maximum score is 10), and a high score indicates a better capacity of selectively controlling movements of the joint.
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Title
Change in Pediatric Berg Balance Scale (PBS)
Description
It assesses balance function in children and has been shown to have good reliability and validity. It has 14 items and each item is scored on a scale of 0 to 4 that a score of 4 indicates the ability to perform the task with minimal or no assistance. The total score is obtained by adding individual scores of each item together, and a higher score indicates better balance function.
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Title
Change in Dyskinesia impairment scale (DIS)
Description
It has two subscales, dystonia and choreoathetosis, and is used to assess the severity of dystonia and choreoathetosis during activity or rest. It has been shown to have good to excellent reliability and validity. In each subscale, the score is rated on a scale of 0 to 4 for both duration and amplitude of each criterion that a score of 0 indicate normal movement and a score of 4 indicates that the motor symptom is always present. The scores will be added together to obtain two subscores, and the total score is the sum of subscores (the highest possible score is 576) and the higher the total score is, the more severs the dystonia or choreoathetosis will be.
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Title
Participant Information Questionnaire
Description
Questionnaire on health status and demographic information
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Title
Change in Quality fo Upper Extremity Skills Test (QUEST)
Description
It has 36 items that evaluate the upper and hand functions with excellent test reliability. The score of each item ranges from -1 to 2. A score of 2 indicates the ability to complete actions as requested, a score of 1 indicate being unable or unwilling to complete actions, or unable to administer the item. A score of -1 is given when abnormal movement is present in the posture section. Initial scores are obtained by adding scores from each section, and these initial scores is standardized to get the total score which ranges from 0 to 100. The higher the score, the better upper limb function will be.
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Title
Change in Gross Motor Function Classification Scale
Description
It evaluates gross motor function with 5 levels with level 5 being the most impaired that requires assistance at all settings (at home, school, outdoors and in the community).
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Title
Change in Modified Tardieu Scale
Description
It evaluates spasticity by measuring the angle of catch and range of motion. Angle of catch is the joint angle at which there is a resistance of muscle when it is passively stretched at different speeds, and range of motion is the range a joint can achieve when the muscle is stretched at a very slow speed. Scores range from 0 to 5. A score of 0 means no resistance of the muscle during the passive movement and a score of 5 indicate the joint immobility.
Time Frame
Tested during assessment sessions to measure change from the baseline at a 10-week period.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Citlali López-Ortiz, M.A., Ph.D
Organizational Affiliation
University of Illinois at Urbana-Champaign
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Urbana-Champaign
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25431617
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.
Results Reference
background
PubMed Identifier
19220390
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.
Results Reference
background
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.
Results Reference
background
PubMed Identifier
30350851
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.
Results Reference
background
PubMed Identifier
23291508
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.
Results Reference
background
PubMed Identifier
27721977
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.
Results Reference
background
PubMed Identifier
20298834
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.
Results Reference
background
PubMed Identifier
18811701
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.
Results Reference
background
PubMed Identifier
27188686
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.
Results Reference
background

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Targeted Ballet Class for Cerebral Palsy

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