Spinal Cord Injuries12-WS SCINCT06256159
Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury
A study testing 12 MSWS questionnaire in people with Spinal Cord Injuries and Gait Disorders, Neurologic, run by University of Zurich at 2 sites in Switzerland.
Trial summary
Established gait assessments for subjects with spinal cord injury (SCI) (6MWT, 10MWT, TUG, SCIM III and WISCI II) are widely used in the clinical and research setting. So far, no valid measurement exists that assesses the patients' perspective of walking ability in SCI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injuries, Gait Disorders, Neurologic
- What is being tested?
- 12 MSWS questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 22 Mar 2024to 5 Mar 2025
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Diagnosis of chronic spinal cord injury (>6 months; cervical or thoracic motor incomplete traumatic or non-traumatic (AIS C, D) above T12
- Must have impaired walking function as demonstrated by neurological examination.
Who cannot join
- Women who are pregnant or breast feeding
- Current orthopaedic problems of lower limbs
- History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
- History of major pulmonary condition (e.g., chronic obstructive pulmonary disease GOLD II-IV
- Current major depression or psychosis
- Participation in another interventional study (except specTra-study) that may have an impact on walking function.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Swiss Paraplegic Center
Nottwil, 6207
Balgrist University Hospital
Zurich, 8008
About this study
Established gait assessments for subjects with spinal cord injury (SCI) (6MWT, 10MWT, TUG, SCIM III and WISCI II) are widely used in the clinical and research setting. So far, no valid measurement exists that assesses the patients' perspective of walking ability in SCI. As there is the 12-item Multiple Sclerosis Walking Scale (12-WS) to assess the patients' perspective on gait ability in patients with multiple sclerosis, it is hypothesized that the 12-WS would also be a valid instrument for subjects with incomplete SCI. The main goal of this study is to collect data from clinical gait assessments in subjects with spinal lesions and to demonstrate that the 12-WS is a valid and reliable patient-reported outcome measurement for individuals with incomplete spinal cord injury.
- Conditions
- Spinal Cord Injuries, Gait Disorders, Neurologic
- Being tested
- 12 MSWS questionnaire
- Medical subject headings
- Spinal Cord Injuries, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 MSWS questionnaireOther
The subject has to perform different gait assessments and fill out the 12-item multiple sclerosis walking scale questionnaire in one visit. Maximum 8 weekes after the first visit the subject has to fill out the same questionnaire again.
| Study group | Role | What they receive |
|---|---|---|
| Patients with incomplete spinal cord injury | Other | Not described Receives: Other: 12 MSWS questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Re-test reliability of the subjective perceived limitations in ambulation of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
The scale is numeric and ranges from 0-100. A lower score means a better outcome.
Measured: Change from day 1 to day 2
Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
The scale is numeric and ranges from 0-100. A lower score means a better outcome.
Measured: Day 1
Secondary outcomes (8)
Clinical examination (a neurological examination including the ASIA score (categoric outcome grade A-E) - International Standards for Neurological Classification of Spinal Cord Injury
Grade "A" means most impaired, grade "E" means less impaired.
Measured: Day 1
Walking impairment (numeric value from 0-20) - WISCI II
The scale is numeric and ranges from 0-20. A higher score means a better outcome.
Measured: Day 1
Walking distance (m) and number of rests - 6MWT
High distance and low number of rests means better outcome.
Measured: Day 1
Walking speed (m/s) - 10-meter walkint test (10MWT)
High speed means better outcome.
Measured: Day 1
Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG)
The fewer seconds needed, the better the outcome.
Measured: Day 1
Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17
The scale is numeric and ranges from 0-30). A higher score means a better outcome.
Measured: Day 1
Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA)
The scale is numeric and ranges from 0-30). A higher score means a better outcome.
Measured: Day 1
Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview
Only subjects with NO changes in impairment level will be used for reliability testing.
Measured: Day 2, maximum 8 weeks after day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start22 Mar 2024
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
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.
- More trials run by University of ZurichThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Paraplegic Research, Nottwil
- Responsible party
- Sponsor
- Investigators
- Björn Zörner, PD Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256159
- Sponsor's protocol ID
- 2023-02304
- Other IDs
- 2023
- Acronym
- 12-WS SCI
- Status last verified
- May 2025
- First submitted
- 19 Jan 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06256159
- Acronym / sponsor ID
- 12-WS SCI / 2023-02304
- Conditions
- Spinal Cord Injuries, Gait Disorders, Neurologic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Swiss Paraplegic Research, Nottwil
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 13 Feb 2024 (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.
Established gait assessments for subjects with spinal cord injury (SCI) (6MWT, 10MWT, TUG, SCIM III and WISCI II) are widely used in the clinical and research setting. So far, no valid measurement exists that assesses the patients' perspective of walking ability in SCI. As there is the 12-item Multiple Sclerosis Walking Scale (12-WS) to assess the patients' perspective on gait ability in patients with multiple sclerosis, it is hypothesized that the 12-WS would also be a valid instrument for subjects with incomplete SCI. The main goal of this study is to collect data from clinical gait assessments in subjects with spinal lesions and to demonstrate that the 12-WS is a valid and reliable patient-reported outcome measurement for individuals with incomplete spinal cord injury.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with incomplete spinal cord injury | Other | Other: 12 MSWS questionnaire |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80 years
- Diagnosis of chronic spinal cord injury (>6 months; cervical or thoracic motor incomplete traumatic or non-traumatic (AIS C, D) above T12
- Must have impaired walking function as demonstrated by neurological examination.
Key exclusion criteria (6 listed)
- Women who are pregnant or breast feeding
- Current orthopaedic problems of lower limbs
- History of major cardiac condition (e.g., infarction, insufficiency (NYHA II-IV))
- History of major pulmonary condition (e.g., chronic obstructive pulmonary disease GOLD II-IV
- Current major depression or psychosis
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 |
|---|---|---|
| 12 MSWS questionnaireThe subject has to perform different gait assessments and fill out the 12-item multiple sclerosis walking scale questionnaire in one visit. Maximum 8 weekes after the first visit the subject has to fill out the same questionnaire again. | Other | Patients with incomplete spinal cord injury |
Primary outcome
Re-test reliability of the subjective perceived limitations in ambulation of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
Time frame: Change from day 1 to day 2
The scale is numeric and ranges from 0-100. A lower score means a better outcome.
Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
Time frame: Day 1
The scale is numeric and ranges from 0-100. A lower score means a better outcome.
8 secondary outcomes
Clinical examination (a neurological examination including the ASIA score (categoric outcome grade A-E) - International Standards for Neurological Classification of Spinal Cord Injury
Time frame: Day 1
Walking impairment (numeric value from 0-20) - WISCI II
Time frame: Day 1
Walking distance (m) and number of rests - 6MWT
Time frame: Day 1
Walking speed (m/s) - 10-meter walkint test (10MWT)
Time frame: Day 1
Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG)
Time frame: Day 1
Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17
Time frame: Day 1
Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA)
Time frame: Day 1
Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview
Time frame: Day 2, maximum 8 weeks after day 1
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 29 May 2025.
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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. This study is not recruiting at the moment.
Björn Zörner, PD Dr. principal investigator
University of Zurich
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 12 MSWS questionnaire in people with Spinal Cord Injuries and Gait Disorders, Neurologic, run by University of Zurich at 2 sites in Switzerland.
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 3 inclusion and 6 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 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Re-test reliability of the subjective perceived limitations in ambulation of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI. (time frame: Change from day 1 to day 2). The study lists 2 primary outcomes in all. 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 29 May 2025; AzTrials last refreshed its copy on 2 Nov 2026.