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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
Texas Scottish Rite Hospital for Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Dance, Action Observation

Eligibility Criteria

4 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 17, 2023
    Last Updated
    October 17, 2023
    Sponsor
    Texas Scottish Rite Hospital for Children
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    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

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    Dance Program for Youth With Cerebral Palsy

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