- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sefa Yıldırım
- 전화번호: +905385984870
- 이메일: syildirim@bezmialem.edu.tr
연구 장소
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Istanbul, 터키 (Türkiye)
- 모병
- Bezmialem Vakıf University
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연락하다:
- Sefa Yıldırım
- 전화번호: +905395984870
- 이메일: syildirim@bezmialem.edu.tr
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
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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.
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활성 비교기: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Balance
기간: Baseline and after 12 weeks
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Balance will be assessed using the Biodex Balance System.
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Baseline and after 12 weeks
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Respiratory Muscle Strength
기간: Baseline and after 12 weeks
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Respiratory muscle strength will be assessed by measuring maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) using a portable mouth pressure device.
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Baseline and after 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Health-Related Quality of Life
기간: Baseline and after 12 weeks
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Health-related quality of life will be evaluated using the Scoliosis Research Society-22 (SRS-22) questionnaire.
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Baseline and after 12 weeks
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Perceived Cosmetic Deformity
기간: Baseline and after 12 weeks
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Perceived cosmetic deformity will be assessed using the Walter Reed Visual Assessment Scale (WRVAS).
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Baseline and after 12 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- BVUsyildirim04
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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