Spinal Cord Injuries (SCI)NCT07695662
The Predictive Value of Lower Extremity Hypertonia on Neurogenic Detrusor Overactivity After Spinal Cord Injury
An observational study of Spinal Cord Injuries (SCI), run by Shengjing Hospital.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2026to 14 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Critical missing information in medical records or urodynamic reports
- Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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:
Read more
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.
- Conditions
- Spinal Cord Injuries (SCI)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study
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).
Measured: Baseline (At hospital admission)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start7 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Jiang, Shengjing Hospital
- Investigators
- Xue Jiang, Principal investigator, Rehabilitation Center of Shengjing Hospital, China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695662
- Sponsor's protocol ID
- 2026PS1154K
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Increased Lower Limb Muscle Tone on Neurogenic Detrusor Overactivity in Patients With Spinal Cord Injury: A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT07695662
- Acronym / sponsor ID
- 2026PS1154K
- Conditions
- Spinal Cord Injuries (SCI)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 7 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 10 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Critical missing information in medical records or urodynamic reports
- Interval between Modified Ashworth Scale assessment and urodynamic study exceeding 2 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xue Jiang principal investigator
Rehabilitation Center of Shengjing Hospital, China Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries (SCI), run by Shengjing Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xue Jiang (+86 18940254064, jiangxueruby@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Neurogenic Detrusor Overactivity Confirmed by Urodynamic Study (time frame: Baseline (At hospital admission)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.