NCT04884724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 8, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2021

Completed
Last Updated

January 14, 2025

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

May 8, 2021

Last Update Submit

January 12, 2025

Conditions

Keywords

Cerebral PalsyTrunk ControlMobilityAdaptive DanceBalance

Outcome Measures

Primary Outcomes (3)

  • 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.

    Change from Baseline TCMS Score at 8 weeks

  • 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.

    Change from Baseline PBS Score at 8 weeks

  • 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.

    Change from Baseline TUG Score at 8 weeks

Secondary Outcomes (1)

  • Pediatric Outcomes Data Collection Instrument (PODCI). Change is being assessed.

    Change from Baseline PODCI Score at 8 weeks

Study Arms (2)

Adaptive Dance Exercise Group

EXPERIMENTAL

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.

Other: Adaptive Dance Exercise Program

Control Group

NO INTERVENTION

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.

Interventions

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.

Adaptive Dance Exercise Group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Işıl Özel Eğitim ve Rehabilitasyon Merkezi

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Ayşe Asena Yekdaneh, Pt.,MSc.

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Lecturer

Study Record Dates

First Submitted

May 8, 2021

First Posted

May 13, 2021

Study Start

May 20, 2021

Primary Completion

September 20, 2021

Study Completion

October 5, 2021

Last Updated

January 14, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations