- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07821255
Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke
Effect of Diaphragmatic Breathing Training on Trunk Control and Postural Stability in Individuals With Chronic Stroke: A Randomized Controlled Trial
연구 개요
상태
상세 설명
The study will use a prospective, two-arm, parallel-group randomized controlled design. Forty individuals with chronic unilateral stroke will be recruited and randomly allocated to either an experimental group or a control group in a 1:1 ratio.
The experimental group will receive standard diaphragmatic breathing training in addition to conventional physiotherapy. The control group will receive the same conventional physiotherapy program without diaphragmatic breathing training.
Both groups will receive three treatment sessions per week for six weeks, for a total of 18 sessions.
Trunk control and postural stability will be assessed at baseline and after completion of the six-week intervention. Trunk control will be assessed using the Trunk Impairment Scale, while postural stability will be assessed using the Biodex Balance System. Functional mobility will be assessed using the Timed Up and Go test.
Primary C
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: fatma shehata mohamad, phD
- 전화번호: +201014001578
- 이메일: Fatma.mohamad@the.suezuni.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:Adults aged 40-65 years.
- Clinically diagnosed unilateral stroke.
- Chronic stroke stage of at least 6 months.
- Able to sit independently without physical assistance.
- Able to walk 10 meters with or without an assistive device.
- Mini-Mental State Examination (MMSE) score ≥24.
- Modified Ashworth Scale (MAS) score ≤2 in the affected upper and lower limb muscles.
- Medically stable.
- Able to understand and follow simple instructions.
- Willing to participate and provide written informed consent. Exclusion Criteria:Other neurological disorders.
- Bilateral neurological deficits or multiple deficits substantially interfering with trunk control, balance, or gait.
- Severe cardiopulmonary disease limiting participation in exercise.
- Severe musculoskeletal disorders affecting the trunk or lower limbs.
- Severe cognitive impairment.
- Severe aphasia preventing understanding of instructions.
- Significant visual or vestibular impairment affecting balance assessment.
- Uncontrolled medical conditions.
- Current participation in another structured rehabilitation program.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Diaphragmatic Breathing Training and Conventional Physiotherapy
Participants will receive conventional physiotherapy combined with standard diaphragmatic breathing training.
Diaphragmatic breathing training will involve slow nasal inspiration emphasizing abdominal/lower rib cage expansion, followed by slow controlled oral expiration while minimizing upper chest and shoulder movement.
Training will be provided for approximately 10-15 minutes per session, three sessions per week for six weeks.
|
Standard diaphragmatic breathing training involving slow nasal inspiration with abdominal and lower rib cage expansion, minimal upper chest movement, and slow controlled oral expiration.
Participants will perform approximately 10 breaths per set for three sets, with rest periods as needed.
Training will be provided for approximately 10-15 minutes per session, three times per week for six weeks.A standardized conventional physiotherapy program including postural alignment and trunk activation, sitting weight-shifting, controlled trunk rotation, sit-to-stand training, standing weight-shifting, static standing balance, and functional mobility/gait training.
Treatment will be provided three times per week for six weeks.
|
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활성 비교기: Conventional Physiotherapy
Participants will receive the same standardized conventional physiotherapy program as the experimental group without diaphragmatic breathing training.
Treatment will be provided three sessions per week for six weeks.
|
Standard diaphragmatic breathing training involving slow nasal inspiration with abdominal and lower rib cage expansion, minimal upper chest movement, and slow controlled oral expiration.
Participants will perform approximately 10 breaths per set for three sets, with rest periods as needed.
Training will be provided for approximately 10-15 minutes per session, three times per week for six weeks.A standardized conventional physiotherapy program including postural alignment and trunk activation, sitting weight-shifting, controlled trunk rotation, sit-to-stand training, standing weight-shifting, static standing balance, and functional mobility/gait training.
Treatment will be provided three times per week for six weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Trunk Impairment Scale
기간: Baseline (Week 0) and post-intervention (Week 6)
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Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination.
Total scores range from 0 to 23, with higher scores indicating better trunk control.
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Baseline (Week 0) and post-intervention (Week 6)
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Trunk Impairment Scale (TIS)
기간: Baseline (Week 0) and post-intervention (Week 6)
|
Trunk control will be assessed using the original 17-item Trunk Impairment Scale, which evaluates static sitting balance, dynamic sitting balance, and coordination.
Total scores range from 0 to 23, with higher scores indicating better trunk control.
|
Baseline (Week 0) and post-intervention (Week 6)
|
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Biodex Postural Stability
기간: Baseline (Week 0) and post-intervention (Week 6)
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Postural stability will be assessed using the Biodex Balance System.
The selected postural stability index will be recorded under standardized testing conditions, with the same test configuration used at baseline and post-intervention.
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Baseline (Week 0) and post-intervention (Week 6)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Timed Up and Go (TUG)
기간: Baseline (Week 0) and post-intervention (Week 6)
|
Functional mobility will be assessed using the 3-meter Timed Up and Go test.
The time required for the participant to stand up from a chair, walk 3 meters, turn, return to the chair, and sit down will be recorded in seconds.
Lower completion time indicates better functional mobility.
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Baseline (Week 0) and post-intervention (Week 6)
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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
- TOMA-PT-2026-005
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
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