- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07603609
Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain
Effects of a Sensorimotor Training Protocol Using a Mobilized Balance Platform on Proprioceptive System, Movement Control, and Quality of Life in Patients With Chronic Low Back Pain
This randomized controlled study aims to investigate the effects of a sensorimotor training protocol using a mobilized balance platform device on proprioceptive system function, movement control, balance, physical performance, pain severity, and quality of life in patients with chronic low back pain. A total of 44 patients with chronic low back pain will be recruited from the outpatient clinic of Gaziler Physical Medicine and Rehabilitation Training and Research Hospital.
Participants will be randomly assigned to either a sensorimotor training group or a control group. The intervention group will receive sensorimotor training using the Huber 360 balance system, while the control group will perform a home exercise program including stretching, spinal mobility, lumbopelvic control, and balance exercises.
Pain severity, proprioception, functional status, balance, physical performance, and quality of life will be assessed before and after treatment by an assessor blinded to group allocation.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sefa Gumruk Aslan
- 전화번호: +903122911503
- 이메일: sefagumrukk@gmail.com
연구 장소
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Ankara, 터키 (Türkiye)
- 모병
- Ankara Gaziler physical therapy and rehabilitation hospital
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연락하다:
- Sefa Gumruk Aslan
- 전화번호: +903122911503
- 이메일: sefagumrukk@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Individuals aged between 18 and 55 years
- Presence of chronic low back pain lasting at least 3 months
- Pain intensity score of 3 or higher on the Visual Analog Scale (VAS)
- Individuals with sufficient cognitive ability to understand and follow study procedures
- Willingness to participate voluntarily in the study
Exclusion Criteria:
- Participation in a similar training program within the last 12 months
- History of lower extremity or spinal surgery
- Presence of non-mechanical low back pain, inflammatory disease, or tumor
- Uncontrolled hypertension or cardiac disease
- History of malignancy
- Presence of radicular symptoms associated with low back pain
- Progressive neurological deficits
- Neurogenic claudication
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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활성 비교기: Home Exercise Program
Participants in this group will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
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Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
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실험적: Huber 360 Sensorimotor Training
Participants in this group will receive a sensorimotor training protocol using the Huber 360 balance system.
The intervention will include progressive rotational and oscillatory exercises aimed at improving proprioception, balance, neuromuscular control, and movement control.
Sessions will be performed for 30 minutes, twice weekly for 5 weeks.
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Participants will perform a home exercise program including warm-up and stretching exercises, spinal mobility exercises, lumbopelvic control exercises, and balance exercises.
The program will be performed for 30 minutes per session, twice weekly for 5 weeks.
Participants will receive sensorimotor training using the Huber 360 balance system.
The protocol will include progressive rotational and oscillatory exercises designed to improve proprioception, balance, neuromuscular control, and movement control in patients with chronic low back pain.
Sessions will be performed for 30 minutes, twice weekly for 5 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lumbar Proprioception Assessment
기간: Before treatment and immediately after completion of the 5-week intervention program
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Lumbar proprioception will be assessed using lumbar repositioning tests at 60 degrees flexion and 15 degrees extension.
Participants will be asked to reproduce target lumbar positions, and the angular repositioning error will be recorded.
Lower repositioning error values indicate better lumbar proprioceptive accuracy.
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Before treatment and immediately after completion of the 5-week intervention program
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain Severity Assessed by Visual Analog Scale
기간: Before treatment and immediately after completion of the 5-week intervention program
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Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS).
Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain severity.
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Before treatment and immediately after completion of the 5-week intervention program
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Functional Status Assessed by Oswestry Disability Index
기간: Before treatment and immediately after completion of the 5-week intervention program
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Functional disability related to low back pain will be assessed using the Oswestry Disability Index (ODI).
Higher scores indicate greater disability.
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Before treatment and immediately after completion of the 5-week intervention program
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Balance and Limits of Stability Assessed by Huber 360
기간: Before treatment and immediately after completion of the 5-week intervention program
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Static balance, dynamic balance, and limits of stability will be assessed using the Huber 360 balance system.
Better balance performance and improved stability limits indicate better postural control.
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Before treatment and immediately after completion of the 5-week intervention program
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Lumbar Flexion Range of Motion
기간: Before treatment and immediately after completion of the 5-week intervention program
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Physical performance will be assessed using a Physical Performance Test Battery including lumbar flexion range of motion, 50-step walking test, 5-minute walking test, five-repetition sit-to-stand test, ten-repetition trunk flexion test, and forward reaching with weight.
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Before treatment and immediately after completion of the 5-week intervention program
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Quality of Life Assessed by Short Form-36
기간: Before treatment and immediately after completion of the 5-week intervention program
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Quality of life will be assessed using the Short Form-36 (SF-36).
Higher scores indicate better health-related quality of life.
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Before treatment and immediately after completion of the 5-week intervention program
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50-Step Walking Test
기간: Before treatment and immediately after completion of the 5-week intervention program
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he time required to complete the 50-step walking test will be recorded in seconds
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Before treatment and immediately after completion of the 5-week intervention program
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Five-Minute Walking Test
기간: Before treatment and immediately after completion of the 5-week intervention program
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The time required to complete five sit-to-stand repetitions will be recorded in seconds.
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Before treatment and immediately after completion of the 5-week intervention program
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Ten-Repetition Trunk Flexion Test
기간: Before treatment and immediately after completion of the 5-week intervention program
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The time required to complete ten trunk flexion repetitions will be recorded in seconds.
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Before treatment and immediately after completion of the 5-week intervention program
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Forward Reaching with Weight Test
기간: Before treatment and immediately after completion of the 5-week intervention program
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Forward reaching distance while holding weight will be measured in centimeters.
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Before treatment and immediately after completion of the 5-week intervention program
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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
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