- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07758712
Effectiveness of a Horse Riding Simulator in Adolescents With Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) is a three-dimensional spinal deformity associated with impaired respiratory muscle strength, balance, postural control, body image, and health-related quality of life. Core stabilization exercises are widely used in the conservative management of AIS. Horse riding simulator training reproduces the multidirectional rhythmic movements of horseback riding while eliminating the potential risks associated with conventional hippotherapy and may provide additional benefits for postural control and trunk muscle activation.
The aim of this randomized controlled trial is to investigate the effects of adding horse riding simulator training to a core stabilization exercise program on respiratory muscle strength, balance, health-related quality of life, and perceived cosmetic deformity in adolescents with idiopathic scoliosis. Participants will be randomly assigned to either an experimental group receiving horse riding simulator training combined with core stabilization exercises or a control group receiving core stabilization exercises alone. Outcomes will be assessed before and after the 12-week intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sefa Yıldırım
- Phone Number: +905385984870
- Email: syildirim@bezmialem.edu.tr
Study Locations
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-
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Istanbul, Turkey (Türkiye)
- Recruiting
- Bezmialem Vakıf University
-
Contact:
- Sefa Yıldırım
- Phone Number: +905395984870
- Email: syildirim@bezmialem.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosis of adolescent idiopathic scoliosis
- Age between 10 and 19 years
- Cobb angle between 10° and 40°, measured on standing spinal radiographs
- Willingness of the participant and, when applicable, the parent or legal guardian to participate in the study
Exclusion Criteria:
- Scoliosis of a non-idiopathic etiology
- History of surgery within the previous 3 months
- Presence of an orthopedic, neurological, or systemic condition that may prevent participation in the exercise program
- Cognitive, communication, or behavioral disorders that may interfere with understanding instructions, answering questions, or performing the exercises
- Participation in regular exercise on 3 or more days per week
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Horse Riding Simulator + Core Stabilization
Participants will receive supervised 60-minute core stabilization exercises combined with 30-minute horse riding simulator training twice weekly for 12 weeks.
Home-based core stabilization exercises will be performed on the remaining days of the week.
|
Participants will receive 30-minute horse riding simulator training twice weekly for 12 weeks in addition to supervised core stabilization exercises.
Each session consists of 5 minutes of warm-up at low speed, 20 minutes of training at the highest speed tolerated by the participant, and 5 minutes of cool-down at low speed.
Participants will perform supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be prescribed for the remaining days of the week.
|
|
Active Comparator: Core Stabilization
Participants will receive supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be performed on the remaining days of the week.
|
Participants will perform supervised 60-minute core stabilization exercises twice weekly for 12 weeks.
Home-based core stabilization exercises will be prescribed for the remaining days of the week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: Baseline and after 12 weeks
|
Balance will be assessed using the Biodex Balance System.
|
Baseline and after 12 weeks
|
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Respiratory Muscle Strength
Time Frame: Baseline and after 12 weeks
|
Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable mouth pressure device.
|
Baseline and after 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-Related Quality of Life
Time Frame: Baseline and after 12 weeks
|
Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire.
|
Baseline and after 12 weeks
|
|
Perceived Cosmetic Deformity
Time Frame: Baseline and after 12 weeks
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Perceived cosmetic deformity will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
|
Baseline and after 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- BVUsyildirim04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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