- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07705984
Kinesio Taping for Neurogenic Bowel Dysfunction in Spinal Cord Injury
Effectiveness of Kinesio Taping on Neurogenic Bowel Dysfunction in Individuals With Spinal Cord Injury: A Randomized Controlled Trial
Neurogenic bowel dysfunction is a common complication of spinal cord injury and may cause constipation, difficulty with defecation, prolonged bowel care, incomplete evacuation, fecal incontinence, and reduced quality of life. This randomized controlled trial aims to evaluate the effectiveness of Kinesio Taping added to a routine bowel management program in adults with spinal cord injury and upper motor neuron-type neurogenic bowel dysfunction.
Thirty participants will be randomly assigned to one of two parallel groups. The control group will receive a routine bowel management program, while the intervention group will receive Kinesio Taping in addition to the routine bowel management program. Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week for 4 weeks.
The primary outcome will be defecation frequency recorded using a 7-day bowel diary. Secondary outcomes will include stool consistency, defecation duration, perceived constipation severity, neurogenic bowel dysfunction severity, and health-related quality of life. Assessments will be performed before and after the 4-week intervention.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Meltem Gunes Akıncı, MD
- 전화번호: +902582966000
- 이메일: meltem_aytekin@hotmail.com
연구 장소
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Denizli
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Denizli, Denizli, 터키 (Türkiye), 20160
- Pamukkale University Hospital
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연락하다:
- Meltem Gunes Akıncı, MD
- 전화번호: +902586000
- 이메일: meltem_aytekin@hotmail.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults aged 18 years or older with traumatic or nontraumatic spinal cord injury
- Neurological level of injury at T12 or above
- Upper motor neuron-type neurogenic bowel dysfunction
- Duration of spinal cord injury longer than 6 months
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Age younger than 18 years
- Neurological level of injury below T12
- Gastrointestinal disease diagnosed before the spinal cord injury, including irritable bowel syndrome or inflammatory bowel disease
- History of conservative treatment for neurogenic bowel dysfunction within the previous 6 months
- Colostomy or history of bowel surgery
- Neurological disease other than spinal cord injury that may cause gastrointestinal or anal sphincter dysfunction
- Cognitive impairment that may interfere with participation in the study
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: Routine Bowel Management Program
Participants in this arm will receive an individualized routine bowel management program based on their clinical condition for 4 weeks.
The program may include scheduled bowel care, dietary and fluid recommendations, appropriate positioning, physical activity, abdominal massage, rectal evacuation techniques, suppositories, enemas, and oral or rectal laxatives when clinically indicated.
Participants will be instructed not to change their usual dietary habits during the study period.
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Participants will receive an individualized routine bowel management program based on their clinical condition for 4 weeks.
The program may include scheduled bowel care, dietary and fluid recommendations, appropriate positioning, physical activity, abdominal massage, rectal evacuation techniques, suppositories, enemas, and oral or rectal laxatives when clinically indicated.
Participants will be instructed not to change their usual dietary habits during the study period.
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실험적: Kinesio Taping Plus Routine Bowel Management Program
Participants in this arm will receive Kinesio Taping in addition to the routine bowel management program for 4 weeks.
Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week by the same experienced physician.
The tape will remain in place for 2 days and will be removed before the next treatment session.
A star-shaped correction technique will be applied to the lumbosacral region with 25%-50% tension, and an I-shaped correction technique will be applied to the lower abdominal region between the right and left anterior superior iliac spines.
No tension will be applied to the ends of the tape
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Participants will receive an individualized routine bowel management program based on their clinical condition for 4 weeks.
The program may include scheduled bowel care, dietary and fluid recommendations, appropriate positioning, physical activity, abdominal massage, rectal evacuation techniques, suppositories, enemas, and oral or rectal laxatives when clinically indicated.
Participants will be instructed not to change their usual dietary habits during the study period.
Kinesio Taping will be applied to the lower abdominal and lumbosacral regions three times per week for 4 weeks.
The tape will remain in place for 2 days and will be removed before the next treatment session.
A star-shaped correction technique will be applied to the lumbosacral region with 25%-50% tension.
An I-shaped correction technique will be applied to the lower abdominal region between the right and left anterior superior iliac spines.
No tension will be applied to the ends of the tape.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Defecation Frequency
기간: Baseline and at the end of the 4-week intervention
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Defecation frequency will be recorded using a 7-day bowel diary and expressed as the total number of defecations during a 7-day period.
Higher values indicate more frequent bowel movements.
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Baseline and at the end of the 4-week intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Bristol Stool Form Scale Score
기간: Baseline and at the end of the 4-week intervention
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Stool consistency will be assessed using the 7-point Bristol Stool Form Scale.
Type 1 indicates separate hard lumps, while Type 7 indicates entirely liquid stool.
Types 3 to 5 generally represent softer or more desirable stool consistency.
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Baseline and at the end of the 4-week intervention
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Change in Perceived Constipation Severity
기간: Baseline and at the end of the 4-week intervention
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Participants will rate the overall severity of constipation on a 10-cm Visual Analog Scale ranging from 0 to 10.
A score of 0 indicates no constipation, while a score of 10 indicates very severe constipation.
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Baseline and at the end of the 4-week intervention
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Change in Neurogenic Bowel Dysfunction Score
기간: Baseline and at the end of the 4-week intervention
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Neurogenic bowel dysfunction severity will be assessed using the 10-item Neurogenic Bowel Dysfunction Score.
The total score ranges from 0 to 47, with higher scores indicating more severe neurogenic bowel dysfunction.
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Baseline and at the end of the 4-week intervention
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Change in Short Form-36 Health Survey Scores
기간: Baseline and at the end of the 4-week intervention
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Health-related quality of life will be assessed using the 36-item Short Form Health Survey.
The instrument includes eight subscales, each scored from 0 to 100.
Higher scores indicate better perceived health status.
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Baseline and at the end of the 4-week intervention
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Change in Defecation Duration
기간: Baseline and at the end of the 4-week intervention
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Defecation duration will be recorded in minutes using a 7-day bowel diary.
Participants will record the time required to complete each bowel evacuation.
A shorter duration indicates less time spent on bowel care.
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Baseline and at the end of the 4-week intervention
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Change in the Feeling of Complete Evacuation
기간: Baseline and at the end of the 4-week intervention
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The feeling of complete bowel evacuation will be recorded in the 7-day bowel diary after each defecation.
The outcome will be expressed as the number or proportion of defecations associated with a feeling of complete evacuation during the 7-day assessment period.
Higher values indicate more frequent complete evacuation.
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Baseline and at the end of the 4-week intervention
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Change in Straining During Defecation
기간: Baseline and at the end of the 4-week intervention
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Straining during defecation will be recorded in the 7-day bowel diary.
The outcome will be expressed as the number or proportion of defecations accompanied by straining during the 7-day assessment period.
Lower values indicate less frequent straining.
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Baseline and at the end of the 4-week intervention
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Change in Painful Defecation
기간: Baseline and at the end of the 4-week intervention
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Painful defecation will be recorded in the 7-day bowel diary.
The outcome will be expressed as the number or proportion of defecations associated with pain during the 7-day assessment period.
Lower values indicate less frequent painful defecation.
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Baseline and at the end of the 4-week intervention
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Dandinoglu T, Kaya E. Kinesio Taping in spinal cord injury rehabilitation: A scoping review. J Spinal Cord Med. 2026 Feb 12:1-9. doi: 10.1080/10790268.2026.2626116. Online ahead of print.
- Karaaslan Y, Karakus A, Koc DO, Bayrakli A, Celenay ST. Effectiveness of Abdominal Massage Versus Kinesio Taping in Women With Chronic Constipation: A Randomized Controlled Trial. J Neurogastroenterol Motil. 2024 Oct 30;30(4):501-511. doi: 10.5056/jnm23131. Epub 2024 Jun 3.
- Orhan C, Kaya Kara O, Kaya S, Akbayrak T, Kerem Gunel M, Baltaci G. The effects of connective tissue manipulation and Kinesio Taping on chronic constipation in children with cerebral palsy: a randomized controlled trial. Disabil Rehabil. 2018 Jan;40(1):10-20. doi: 10.1080/09638288.2016.1236412. Epub 2016 Oct 28.
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- E-60116787-020-887485
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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