- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07695662
The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury
The Predictive Value of Increased Lower Limb Muscle Tone on Neurogenic Detrusor Overactivity in Patients With Spinal Cord Injury: A Retrospective Analysis
The goal of this observational study is to evaluate whether increased lower extremity muscle tone can serve as an independent predictor of neurogenic detrusor overactivity (NDO) in adult patients (aged 18-80 years) with upper sacral spinal cord injury .
The main questions it aims to answer are:
Is increased lower extremity muscle tone independently associated with the presence of detrusor overactivity after adjusting for age, sex, injury level, injury type, and injury cause?
Does the predictive value of muscle tone for detrusor overactivity differ across subgroups defined by injury level, injury severity, and time since injury?
Researchers will compare patients with lower extremity hypertonia (Modified Ashworth Scale ≥ 1) to patients with normal muscle tone (Modified Ashworth Scale = 0) to see if muscle tone elevation independently predicts detrusor overactivity.
Participants will not be asked to do anything beyond their routine clinical care, as this is a retrospective study that only collects data from existing medical records, including neurological examination results, Modified Ashworth Scale scores, and urodynamic study reports.
연구 개요
상태
정황
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Xue Jiang
- 전화번호: +86 18940254064
- 이메일: jiangxueruby@163.com
연구 연락처 백업
- 이름: Siyan Lu
- 전화번호: +86 15998390096
- 이메일: 940436682@qq.com
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Diagnosis of spinal cord injury confirmed by CT or MRI imaging
Suprasacral spinal cord injury according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI, 2011 revision)
Age between 18 and 80 years
Complete medical records, including detailed neurological examination, Modified Ashworth Scale assessment, and urodynamic study report
Exclusion Criteria:
Critical missing information in medical records or urodynamic reports
Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Hypertonia Group
Patients with lower extremity hypertonia, defined as a Modified Ashworth Scale (MAS) score of 1 or higher at admission.
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Normal Tone Group
Patients with normal lower extremity muscle tone, defined as a Modified Ashworth Scale (MAS) score of 0 at admission.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study
기간: Baseline (At hospital admission)
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Neurogenic detrusor overactivity (NDO) is defined as the presence of involuntary detrusor contractions during the filling phase of a urodynamic study, according to International Continence Society (ICS) standards.
Urodynamic studies were performed as part of routine clinical care during the hospital admission.
This outcome measures the presence or absence of NDO based on the urodynamic report.
The result is reported as a binary outcome (present/absent).
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Baseline (At hospital admission)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .