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Completed

NCT Number: NCT04237506

Targeted Ballet Class for Cerebral Palsy

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

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Key information

Age range

3 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted ballet dance

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. 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).

  7. 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.

Sponsors and collaborators

Lead sponsor

Citlali Lopez-Ortiz

Other

Registry information

Official study title

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

Acronym: TBCCP

Important dates

Study start
2017
Primary completion
2018
Study completion
2021
First posted
Jan 23, 2020
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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