Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury

9. juli 2026 opdateret af: Xue Jiang, Shengjing Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

300

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

This study looks at adults aged 18 to 80 with suprasacral Spinal Cord Injury who stayed at the Shengjing Hospital of China Medical University from January 2020 to January 2025. All participants have full medical records, including neurological exams, Modified Ashworth Scale checks, and urodynamic test results. Anyone missing key data or with assessments spaced out by more than two weeks was left out.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Hypertonia Group
Patients with lower extremity hypertonia, defined as a Modified Ashworth Scale (MAS) score of 1 or higher at admission.
Normal Tone Group
Patients with normal lower extremity muscle tone, defined as a Modified Ashworth Scale (MAS) score of 0 at admission.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study
Tidsramme: Baseline (At hospital admission)
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).
Baseline (At hospital admission)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Shengjing Hospital

Efterforskere

  • Ledende efterforsker: Xue Jiang, Rehabilitation Center of Shengjing Hospital, China Medical University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

7. juli 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

14. juni 2027

Datoer for studieregistrering

Først indsendt

6. juli 2026

Først indsendt, der opfyldte QC-kriterier

9. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026PS1154K

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner