Cerebral PalsyTBCCPNCT04237506
Targeted Ballet Class for Cerebral Palsy
A study testing Targeted ballet dance in people with Cerebral Palsy, run by Citlali Lopez-Ortiz at 1 site in United States.
Trial summary
This study aims to investigate the effect of the targeted ballet dance on participants with cerebral palsy Read more about this study
- Who is it for?
- Ages 3 to 64 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Targeted ballet dance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 13 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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).
Who cannot join
- Not meeting ALL of the criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: 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
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- Targeted ballet dance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Targeted ballet danceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | All participants in this group will take the one-hour ballet dance class twice per week for six weeks Receives: Behavioral: Targeted ballet dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
Participant Information Questionnaire
Questionnaire on health status and demographic information
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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).
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
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.
Measured: Tested during assessment sessions to measure change from the baseline at a 10-week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start24 Jan 2017
- Primary completion30 Nov 2018
- Study completion13 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Children and adults with cerebral palsy
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Citlali Lopez-Ortiz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Citlali Lopez-Ortiz, University of Illinois at Urbana-Champaign
- Investigators
- Citlali López-Ortiz, M.A., Ph.D, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237506
- Sponsor's protocol ID
- 16718
- Other IDs
- 16CN1335
- Acronym
- TBCCP
- Status last verified
- Mar 2021
- First submitted
- 31 Dec 2019
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25431617Fowler 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.
PubMed 19220390Rodrigues, 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.
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.
PubMed 30350851Chen 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.
PubMed 23291508Lopez-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.
PubMed 27721977Gracies 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.
PubMed 20298834Klingels 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.
PubMed 18811701Graham 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.
PubMed 27188686Lopez-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.
PubMed 39506647
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Ballet Class for Increased Range of Motion and Stretch Reflex Regulation in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04237506
- Acronym / sponsor ID
- TBCCP / 16718
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Citlali Lopez-OrtizUniversity, hospital or other
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 13 Feb 2021 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Children and adults with cerebral palsy
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Targeted ballet danceAll participants in this group will take the one-hour ballet dance class twice per week for six weeks |
Who may qualify
- Ages
- 3 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Not meeting ALL of the criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Targeted ballet danceThe 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. | Behavioural | Intervention group |
Primary outcome
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.
7 secondary outcomes
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.
Change in Pediatric Berg Balance Scale (PBS)
Time frame: 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.
Participant Information Questionnaire
Time frame: 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.
Change in Gross Motor Function Classification Scale
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Background: PubMed 25431617Lopez-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.
- Background: PubMed 19220390Fowler 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.
- BackgroundRodrigues, 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: PubMed 30350851Lopez-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.
- Background: PubMed 23291508Chen 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.
- Background: PubMed 27721977Lopez-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.
- Background: PubMed 20298834Gracies 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.
- Background: PubMed 18811701Klingels 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.
- Background: PubMed 27188686Graham 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.
- Derived from this study: PubMed 39506647Lopez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Citlali López-Ortiz, M.A., Ph.D principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Targeted ballet dance in people with Cerebral Palsy, run by Citlali Lopez-Ortiz at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04237506, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021; AzTrials last refreshed its copy on 30 Oct 2026.