Targeted Ballet Class for Cerebral Palsy (TBCCP)

March 17, 2021 updated by: Citlali Lopez-Ortiz

Targeted Ballet Class for Increased Range of Motion and Stretch Reflex Regulation in Cerebral Palsy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Urbana, Illinois, United States, 61801
        • University of Illinois at Urbana-Champaign

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 64 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
All participants in this group will take the one-hour ballet dance class twice per week for six weeks
Behavioral: Targeted ballet dance
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montreal Stretch Reflex Threshold
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Selective control assessment of the lower extremity (SCALE) Score Sheet
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Change in Pediatric Berg Balance Scale (PBS)
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Change in Dyskinesia impairment scale (DIS)
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Participant Information Questionnaire
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
Questionnaire on health status and demographic information
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Change in Quality fo Upper Extremity Skills Test (QUEST)
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Change in Gross Motor Function Classification Scale
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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).
Tested during assessment sessions to measure change from the baseline at a 10-week period.
Change in Modified Tardieu Scale
Time Frame: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Tested during assessment sessions to measure change from the baseline at a 10-week period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Citlali Lopez-Ortiz

Investigators

  • Principal Investigator: Citlali López-Ortiz, M.A., Ph.D, University of Illinois at Urbana-Champaign

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

February 13, 2021

Study Registration Dates

First Submitted

December 31, 2019

First Submitted That Met QC Criteria

January 17, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

March 18, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16718
  • 16CN1335 (Other Identifier: Carle Foundation Hospital IRB, Urbana IL)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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