- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07680374
Dance-Based Exercise in Adolescent Idiopathic Scoliosis
Effects of Dance-Based Exercises on Physical Fitness, Body Image, and Quality of Life in Adolescents With Idiopathic Scoliosis: A Randomized Controlled Trial
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity associated with physical and psychosocial impairments. Although conventional exercise programs are beneficial, maintaining long-term adherence may be challenging in adolescents. Dance-based exercise programs offer a potentially enjoyable and motivating alternative.
This prospective randomized controlled study will include 24 adolescents with AIS aged 10-18 years. Participants will be randomly allocated into an intervention group and a control group (12 participants per group). Both groups will perform conventional scoliosis exercises, while the intervention group will additionally participate in dance-based exercise sessions for six weeks.
Assessments will be conducted at baseline and after six weeks. Primary outcomes will include body image and health-related quality of life. Secondary outcomes will include physical fitness, flexibility, trunk rotation, and enjoyment of physical activity.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
-
Istanbul, Turkije (Türkiye)
- Istanbul Atlas University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Age between 10 and 18 years
- Diagnosis of adolescent idiopathic scoliosis
- Cobb angle between 10° and 30°
- No previous dance training
- Not participating regularly in another exercise program
Exclusion Criteria:
- Previous scoliosis surgery
- Neuromuscular or congenital scoliosis
- Neurological, orthopedic, psychiatric, cardiovascular, or pulmonary disorders -preventing exercise participation
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Dance-Based Exercise Group
Participants will perform conventional scoliosis exercises and additional dance-based exercises for six weeks.
|
Participants will receive dance-based exercise sessions for 6 weeks (one face-to-face and one online session per week) in addition to conventional scoliosis exercises.
Participants will perform only conventional scoliosis exercises for six weeks.
|
|
Actieve vergelijker: Conventional Scoliosis Exercise Program
Participants will perform conventional scoliosis exercises during the 6-week study period.
|
Participants will perform only conventional scoliosis exercises for six weeks.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Flexibility-Forward Bending Test
Tijdsspanne: Baseline and 6 weeks
|
Spinal flexibility will be assessed using the Forward Bending Test.
Participants will bend forward from a standing position with the knees fully extended and attempt to reach toward the floor.
The distance between the tip of the middle finger and the floor will be measured in centimeters.
Lower values indicate greater trunk and posterior chain flexibility.
|
Baseline and 6 weeks
|
|
Flexibility-Lateral Flexion Test
Tijdsspanne: Baseline and 6 Weeks
|
Trunk lateral flexibility will be assessed using the Lateral Flexion Test.
Participants will perform maximal lateral trunk flexion to each side while standing with the knees extended.
The distance reached by the tip of the middle finger along the lateral aspect of the thigh will be measured in centimeters.
Higher values indicate greater lateral trunk flexibility.
|
Baseline and 6 Weeks
|
|
Core Muscle Endurance-Trunk Flexion Test
Tijdsspanne: Baseline and 6 weeks
|
The endurance of the trunk flexor muscles will be assessed using the Trunk Flexion Test.
Participants will maintain the standardized trunk flexion position for as long as possible.
Performance will be recorded as endurance time in seconds.
Higher values indicate greater trunk flexor muscle endurance.
|
Baseline and 6 weeks
|
|
Core Muscle Endurance-Lateral Bridge Test
Tijdsspanne: Baseline and 6 Weeks
|
Lateral core muscle endurance will be assessed using the Lateral Bridge Test.
Participants will maintain the side bridge position for as long as possible.
Endurance time will be recorded in seconds, with higher values indicating better lateral trunk muscle endurance.
|
Baseline and 6 Weeks
|
|
Core Muscle Endurance - Prone Bridge Test
Tijdsspanne: Baseline and 6 Weeks
|
Global core muscle endurance will be assessed using the Prone Bridge Test.
Participants will maintain the prone bridge (plank) position for as long as possible.
Performance will be recorded as endurance time in seconds.
Higher values indicate greater global core muscle endurance.
|
Baseline and 6 Weeks
|
|
Core Muscle Endurance- Modified Biering-Sorensen Test
Tijdsspanne: Baseline and 6 Weeks
|
The endurance of the trunk extensor muscles will be assessed using the Modified Biering-Sørensen Test.
Participants will maintain the standardized horizontal trunk position for as long as possible.
Performance will be recorded as endurance time in seconds.
Higher values indicate greater trunk extensor muscle endurance.
|
Baseline and 6 Weeks
|
|
Functional Exercise Capacity
Tijdsspanne: Baseline and 6 Weeks
|
6 Minute Walk Test
|
Baseline and 6 Weeks
|
|
Dynamic Balance
Tijdsspanne: Baseline and 6 Weeks
|
Y Balance
|
Baseline and 6 Weeks
|
|
Trunk Rotation
Tijdsspanne: Baseline and 6 Weeks
|
Thoracic and Lumbar Rotation Measurements
|
Baseline and 6 Weeks
|
|
Body Image-Walter Reed Visual Assessment Scale
Tijdsspanne: Baseline and 6 Weeks
|
Perceived trunk deformity will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
The WRVAS is a patient-reported outcome measure consisting of seven items evaluating the perceived severity of spinal deformity through standardized illustrations.
Each item is scored on a 5-point scale, yielding a total score ranging from 7 to 35.
Higher scores indicate greater perceived spinal deformity.
|
Baseline and 6 Weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Health-Related Quality of Life-Scoliosis Research Society-22 Questionnaire
Tijdsspanne: Baseline and 6 Weeks
|
Health-related quality of life will be assessed using the Scoliosis Research Society-22 Questionnaire (SRS-22).
The questionnaire consists of 22 items evaluating five domains: function/activity, pain, self-image, mental health, and satisfaction with management.
Each item is scored on a 5-point Likert scale.
The total (or mean) score will be calculated, with higher scores indicating better health-related quality of life.
|
Baseline and 6 Weeks
|
|
Enjoyment of Physical Activity
Tijdsspanne: Baseline and 6 Weeks
|
Physical Activity Enjoyment Scale
|
Baseline and 6 Weeks
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Meltem Kaya, Assoc. Prof., Atlas University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AtlasUmkaya06
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .