Dance Program for Youth With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adapted Dance Program
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Dance, Action Observation
Eligibility Criteria
Inclusion Criteria: Diagnosis of cerebral palsy GMFCS levels 1 or 2 MACS levels 1-3 Aged 4-17 years Able to follow directions in English Ability to complete the assessment protocol Does not have any restrictions/contraindications following a medical procedure that prohibits movement Exclusion Criteria: has uncontrolled epilepsy has severe behavioral problems unable to complete the assessment protocol
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Dance Program
Arm Description
10-week adapted dance program (20 hours)
Outcomes
Primary Outcome Measures
Pediatric Balance Scale (PBS)
a 14-item criterion referenced measure that tests functional balance for pediatric patients in everyday tasks with a sum score of 0-56. A higher score represents better balance.
6 minute walk test (6MWT)
a standardized, self-paced walking test that is used to measure functional ability; the score is the amount of meters walked in 6 minutes; longer distances walked represents better function
The Cerebral Palsy Quality of Life Questionnaire (CPQOL)
a standardized patient reported outcome measure that measures quality of life; it is completed by the caregiver and by children with CP ages 9+; each item is rated on a scale from 1-9, higher ratings indicate better quality of life
Child and Adolescent Scale of Participation (CASP)
20-item caregiver questionnaire that measures a child or adolescent's participation in home, school, and community with a sum score of 20-80; a higher score represents higher participation
Secondary Outcome Measures
Modified Ashworth Scale (MAS)
standardized measurement of tone on a 5 point scale (0, 1, 1+, 2, 3); a higher score represents increased tone
Quality of Upper Limb Extremity Skills Test (QUEST) (optional)
standardized, criterion-referenced assessment that measures dissociated movement, grasp, protective extension, and weight bearing that is reported using a standard score ranging from 0-100. A higher score represents better upper limb function.
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) -subsections (bilateral coordination and upper limb coordination) (optional)
standardized, norm-referenced assessment that measures fine and gross motor skills; subtests are scored using scaled scores with a mean of 15 and standard deviation of 5. A higher score represents higher motor performance.
Full Information
NCT ID
NCT06100562
First Posted
October 17, 2023
Last Updated
October 17, 2023
Sponsor
Texas Scottish Rite Hospital for Children
1. Study Identification
Unique Protocol Identification Number
NCT06100562
Brief Title
Dance Program for Youth With Cerebral Palsy
Official Title
Dance Program for Youth With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Scottish Rite Hospital for Children
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The goal of this prospective cohort study is to learn about the impact of an adapted dance program in youth with cerebral palsy. The main questions it aims to answer are:
Are there clinically significant benefits for children with cerebral palsy who participate in an Adaptive Dance Program?
Is it feasible to implement an adaptive dance program using action-observation principles for children diagnosed with Cerebral Palsy (CP)? Participants will complete a pre-dance program assessment, participate in a 10-week dance program (20 hours), and complete a post-dance program assessment.
Detailed Description
Purpose:
Cerebral palsy (CP) is defined as a group of permanent disorders of the development of movement and posture that are attributed to non-progressive disturbances which occurred in the developing fetal or infant brain (Rosenbaum et. al, 2007). As children with CP experience development and growth, motor disorders present along with disorders related to sensation, perception, cognition, and/or a seizure disorder (Rosenbaum et. al, 2007). The way that CP manifests itself can change over time as a child grows and their surrounding environment changes, however, the lesion does not change. Throughout childhood and adolescence, a common obstacle that children with cerebral palsy face is a lack of participation and inclusion in the same leisure activities containing physical activity as their peers due to physical, cognitive, and social limitations (Radsel et. al, 2016; Verschuren et. al, 2012). Currently, there is limited research pertaining to the concepts of adapted dance and its relation to children with CP and in turn, limited information about the benefits that these programs offer to the target population.
Background and Intervention participation and inclusion in the same leisure activities containing physical activity as their peers due to physical, cognitive, and social limitations (Radsel et. al, 2016; Verschuren et. al, 2012). Children with CP who lack opportunities for physical activity are at increased risk for fatigue, injury, and pain secondary to maladaptation resulting from exacerbating physical impairments (Tow et. al, 2020). To decrease these risks, it is imperative that children with CP participate in physical activity and develop a habit of healthy exercise (Runciman et. al, 2016). However, opportunities for physical activity must have accommodations for physical and cognitive deficits experienced by this population. Thus, an adapted sports program, such as dance, can be developed to cater to the target population. The program developed should be a physical activity that is meaningful and engaging. Thus, an adapted dance or sports program for the target population could be an effective solution to the obstacle.
Of the current research conducted on adaptive dance programs for children with CP, there is an overall theme of the active ingredients used in the programs. Each dance class was 60 minutes in length for 2-3x per week depending on the study. Most of the dance programs recruited volunteers to support participants throughout the dance class as needed. All programs consisted of a warm-up section and a cool-down portion at the end of class. The type of dance ranged in each study from hip-hop, ballet, and a variety of all dance types. The major theme of all adaptive dance programs for children with CP included focus on repetition of movements and an improvisation portion of the class. Dance movements were focused on balance, postural control, and directional movements. All programs consisted of a dance performance for participants' families and friends. The main outcomes from (Lakes et al., 2019) included significant gait improvement and control of movements. According to (Withers et al., 2019), major outcomes of the adaptive dance program included significant improvement in coordination, balance, and endurance. The main results from (Cherriere et al., 2020) showed an increase in static and dynamic balance amongst the majority of participants.
The use of the action-observation treatment intervention strategy has yielded a significant amount of evidence that shows the activation of the mirror neuron system can help improve specific motor skills. This motor learning technique has been successfully applied in a variety of adult populations such as stroke patients and Parkinson's disease patients, as well as more recently, children with cerebral palsy (Buccino, 2014). In the context of rehabilitation sessions, patients typically work on one action per session, and this action is separated into 3 to 4 consecutive motor actions. Each action is observed for at least 3 minutes, with the total action then taking 12 minutes to observe. Actions are shown from multiple perspectives to further enhance learning. Following the observation, participants spend at least 2 minutes imitating the observed actions. The total time a session takes is typically 30 minutes.
In the context of a dance class, the research team will incorporate an action-observation technique as a method of teaching choreography steps. A section of a dance routine will be focused on for the duration of one class session, with the dance section broken up into 3 to 4 smaller movements. The environmental aspect of adding a mirror will add multiple perspectives for participants to observe the instructor performing dance actions, which could enhance learning and comprehension of dance moves.
Study Design A quasi-experimental mixed-method study will be conducted with clinical assessments completed pre-intervention and post-intervention to determine the feasibility and the impact of the intervention. The intervention will consist of participating in a 1-hour class, two times a week for 10 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Dance, Action Observation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dance Program
Arm Type
Experimental
Arm Description
10-week adapted dance program (20 hours)
Intervention Type
Behavioral
Intervention Name(s)
Adapted Dance Program
Intervention Description
Participants will attend a 2x/weekly adaptive dance session for 10 weeks. If participants miss a class due to illness or an unexpected event (loss of transportation, family emergency/need) they will receive a video of the content missed and can complete the session at home.
Each class will start with a 10 min warm-up that will include stretching and motor games.
Learn a section of choreography every session using action-based intervention for 30 minutes.
Break for 5 min.
Improvisation part of class for 10 min.
Cool-down for 5 min.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale (PBS)
Description
a 14-item criterion referenced measure that tests functional balance for pediatric patients in everyday tasks with a sum score of 0-56. A higher score represents better balance.
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Title
6 minute walk test (6MWT)
Description
a standardized, self-paced walking test that is used to measure functional ability; the score is the amount of meters walked in 6 minutes; longer distances walked represents better function
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Title
The Cerebral Palsy Quality of Life Questionnaire (CPQOL)
Description
a standardized patient reported outcome measure that measures quality of life; it is completed by the caregiver and by children with CP ages 9+; each item is rated on a scale from 1-9, higher ratings indicate better quality of life
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Title
Child and Adolescent Scale of Participation (CASP)
Description
20-item caregiver questionnaire that measures a child or adolescent's participation in home, school, and community with a sum score of 20-80; a higher score represents higher participation
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Secondary Outcome Measure Information:
Title
Modified Ashworth Scale (MAS)
Description
standardized measurement of tone on a 5 point scale (0, 1, 1+, 2, 3); a higher score represents increased tone
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Title
Quality of Upper Limb Extremity Skills Test (QUEST) (optional)
Description
standardized, criterion-referenced assessment that measures dissociated movement, grasp, protective extension, and weight bearing that is reported using a standard score ranging from 0-100. A higher score represents better upper limb function.
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Title
Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) -subsections (bilateral coordination and upper limb coordination) (optional)
Description
standardized, norm-referenced assessment that measures fine and gross motor skills; subtests are scored using scaled scores with a mean of 15 and standard deviation of 5. A higher score represents higher motor performance.
Time Frame
within 2 weeks of start of intervention (pre-intervention), within 2 weeks of end of intervention (post-intervention)
Other Pre-specified Outcome Measures:
Title
Demographic information
Description
including age in years, gender, etiology of cerebral palsy, previous exposure to therapy (qualitative)
Time Frame
within 2 weeks of start of intervention (pre-intervention)
Title
Manual Ability Classification Scale (MACS)
Description
The Manual Ability Classification Scale describes how children with cerebral palsy use their hands during activities of daily living with 1 being the least functional and 5 being the most functional
Time Frame
within 2 weeks of start of intervention (pre-intervention)
Title
Gross Motor Function Classification System (GMFCS)
Description
The Gross Motor Function Classification Systems is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy with 1 being the lowest functioning and 5 being the highest
Time Frame
within 2 weeks of start of intervention (pre-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of cerebral palsy
GMFCS levels 1 or 2
MACS levels 1-3
Aged 4-17 years
Able to follow directions in English
Ability to complete the assessment protocol
Does not have any restrictions/contraindications following a medical procedure that prohibits movement
Exclusion Criteria:
has uncontrolled epilepsy
has severe behavioral problems
unable to complete the assessment protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Shierk, PhD
Phone
(469) 412-7172
Ext
1045
Email
angela.shierk@tsrh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Christie, MD
Organizational Affiliation
Scottish Rite for Children
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Dance Program for Youth With Cerebral Palsy
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