Spinal Cord InjuriesNCT04951297
Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury
An observational study of Spinal Cord Injuries, run by Peking University Third Hospital.
Trial summary
To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- None, just observation
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 1 Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 102
Who may be able to join
- patients with SCI
Who cannot join
- had neurologic impairments unrelated to SCI, such as peripheral nerve injury, brain injury and cognitive deficits, or if they were unable to complete the questionnaire.
About this study
To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI.
- Conditions
- Spinal Cord Injuries
- Being tested
- None, just observation
- 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.
None, just observationOther
None ,just observation test
What is being measured
The primary outcome is the main question the study is designed to answer.
sacral sparing self-report questionnaire
sacral sparing self-report questionnaire
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start1 Jan 2013
- Primary completion1 Jan 2016
- Study completion1 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04951297
- Sponsor's protocol ID
- BYSY201109
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Bowel-routine-based Self Report Questionnaire for Sacral Sparing After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04951297
- Acronym / sponsor ID
- BYSY201109
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- 1 Jan 2016 (actual)
- First posted
- 6 Jul 2021 (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.
To develop a self-administered tool for assessment of sacral sparing after spinal cord injury (SCI) and to test its validity in individuals with SCI.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 102
Key inclusion criteria (1 listed)
- patients with SCI
Key exclusion criteria (1 listed)
- had neurologic impairments unrelated to SCI, such as peripheral nerve injury, brain injury and cognitive deficits, or if they were unable to complete the questionnaire.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None, just observationNone ,just observation test | Other | – |
Primary outcome
sacral sparing self-report questionnaire
Time frame: 12months
sacral sparing self-report questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
Related trials for Spinal Cord Injuries
Recruiting
Efficacy of rTMS Treatment After Spinal Cord Injury
Spinal Cord Injuries, Myelopathy
Enrolling by invitation
NeuroSuitUp: Neurorehabilitation Through Synergistic Man-machine Interfaces
Spinal Cord Injuries
Active, not recruitingObservational study
Recovery and Safety After Epidural Spinal Cord Stimulation in People With Spinal Cord Injury
Spinal Cord Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingPhase 2
Extracorporeal Shockwave Therapy as an Additional Treatment for Spasticity Secondary to Spinal Cord Injury
Spinal Cord Injury, Spasticity
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries, run by Peking University Third 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 6 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sacral sparing self-report questionnaire (time frame: 12months). 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 6 Jul 2021.