search
Back to results

Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Adaptive Dance Exercise Program
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Trunk Control, Mobility, Adaptive Dance, Balance

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with Cerebral Palsy
  • Volunteer
  • Ages between of 6-18 years
  • Gross Motor Function Classification System (GMFCS) Level 1 and Level 2
  • To have cognitive skills to understand and apply adaptive dance exercises to be given.

Exclusion Criteria:

  • Participants diagnosed with Cerebral Palsy having cognitive disorders
  • Participants diagnosed with Cerebral Palsy having vision or hearing problems
  • Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.

Sites / Locations

  • Istanbul University-Cerrahpasa
  • Işıl Özel Eğitim ve Rehabilitasyon Merkezi

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adaptive Dance Exercise Group

Control Group

Arm Description

In addition to the routine physiotherapy programs received in the rehabilitation center for children and adolescents with cerebral palsy, an adaptive dance exercise program will be applied 2 days a week in the rehabilitation center for 5 weeks and online for 3 weeks in the presence of a physiotherapist. The duration of each session of the adaptive dance exercises to be applied is planned to be 45-60 minutes. It is planned that the adaptive dance exercises to be applied will be accompanied by the selected song. Before and after the 8-week exercise program, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests.

Children and adolescents diagnosed with Cerebral Palsy will continue their routine physiotherapy and rehabilitation programs in the rehabilitation center. At the beginning of the study and after 8 weeks, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests.

Outcomes

Primary Outcome Measures

Trunk Control Measurement Scale (TCMS). Change is being assessed.
TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.
Pediatric Balance Scale (PBS). Change is being assessed.
The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.
Time Up and Go (TUG). Change is being assessed.
The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.

Secondary Outcome Measures

Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.
PODCI has 2 parent forms (child and adolescent) and adolescent forms consisting of the same questions. The test is a Likert-type scale and consists of 5 parts: Upper Extremity Functions-UEF, Physical Function and Sport-FFS, Transfer and Basic Mobility-TM, Pain-RA and Happiness / Satisfaction-MM, as well as Expectations-TB section where expectations from treatment are questioned. Each section is calculated between 0-100. Participants' quality of life will be evaluated with PODCI.

Full Information

First Posted
May 8, 2021
Last Updated
October 5, 2021
Sponsor
Istanbul University - Cerrahpasa (IUC)
search

1. Study Identification

Unique Protocol Identification Number
NCT04884724
Brief Title
Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy
Official Title
Effects of Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Children and Adolescents With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
September 20, 2021 (Actual)
Study Completion Date
October 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Dance, whose main purpose is to achieve a satisfying motor performance, increases motor learning with sensory, perceptual and emotional components. Although the effects of dance therapy on functionality, balance and participation in people with CP have been previously examined in the literature, it has been reported that the evidence is insufficient and more studies are needed. The aim of this study is to examine the effects of adaptive dance exercise program on trunk control, balance and functional mobility in children and adolescents with Cerebral Palsy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Trunk Control, Mobility, Adaptive Dance, Balance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adaptive Dance Exercise Group
Arm Type
Experimental
Arm Description
In addition to the routine physiotherapy programs received in the rehabilitation center for children and adolescents with cerebral palsy, an adaptive dance exercise program will be applied 2 days a week in the rehabilitation center for 5 weeks and online for 3 weeks in the presence of a physiotherapist. The duration of each session of the adaptive dance exercises to be applied is planned to be 45-60 minutes. It is planned that the adaptive dance exercises to be applied will be accompanied by the selected song. Before and after the 8-week exercise program, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Children and adolescents diagnosed with Cerebral Palsy will continue their routine physiotherapy and rehabilitation programs in the rehabilitation center. At the beginning of the study and after 8 weeks, the participants' trunk stabilization, balance, functional mobility and quality of life will be questioned with determined questionnaires and tests.
Intervention Type
Other
Intervention Name(s)
Adaptive Dance Exercise Program
Intervention Description
It is planned to include balance, stabilization, mobility, speed and rhythm activities for the exercises applied in Cerebral Palsy rehabilitation and based on the principles of motor learning, and to apply the dance steps and figures to be applied with visual and auditory stimuli.
Primary Outcome Measure Information:
Title
Trunk Control Measurement Scale (TCMS). Change is being assessed.
Description
TCMS consists of static sitting balance, dynamic sitting control (Selective motor control and dynamic reaching) sections. The scale consists of 15 items in total and is divided into five, seven and three items. All items are evaluated bilaterally and scored on a 2, 3 or 4 point rank scale. TCMS total score is between 0-58 and the higher the score, the better the performance. Participants' trunk stabilization will be evaluated with TCMS.
Time Frame
Change from Baseline TCMS Score at 8 weeks
Title
Pediatric Balance Scale (PBS). Change is being assessed.
Description
The five-level consists of 14 elements such as sitting balance, standing balance, standing up from sitting, moving from standing to sitting, transfers, stepping, reaching, turning and jumping. Each item is scored between 0-4 points. High scores indicate better performance. Participants' balance will be evaluated with PBS.
Time Frame
Change from Baseline PBS Score at 8 weeks
Title
Time Up and Go (TUG). Change is being assessed.
Description
The participant sitting on the floor without arm support, hip and knee flexed at 90 degrees and feet on the ground are asked to stand up, walk 3 meters, turn around and sit on the chair. The test is applied 3 times, the time is recorded and the average of 3 trials is taken. Participants' functional mobility will be evaluated with TUG.
Time Frame
Change from Baseline TUG Score at 8 weeks
Secondary Outcome Measure Information:
Title
Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.
Description
PODCI has 2 parent forms (child and adolescent) and adolescent forms consisting of the same questions. The test is a Likert-type scale and consists of 5 parts: Upper Extremity Functions-UEF, Physical Function and Sport-FFS, Transfer and Basic Mobility-TM, Pain-RA and Happiness / Satisfaction-MM, as well as Expectations-TB section where expectations from treatment are questioned. Each section is calculated between 0-100. Participants' quality of life will be evaluated with PODCI.
Time Frame
Change from Baseline PODCI Score at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Cerebral Palsy Volunteer Ages between of 6-18 years Gross Motor Function Classification System (GMFCS) Level 1 and Level 2 To have cognitive skills to understand and apply adaptive dance exercises to be given. Exclusion Criteria: Participants diagnosed with Cerebral Palsy having cognitive disorders Participants diagnosed with Cerebral Palsy having vision or hearing problems Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Asena Gülnergiz, Pt.,MSc.
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
Country
Turkey
Facility Name
Işıl Özel Eğitim ve Rehabilitasyon Merkezi
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy

We'll reach out to this number within 24 hrs