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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Citlali Lopez-Ortiz

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 13, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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