Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury

Spinal Cord Injuries Clinical Trial

— 12-WS SCI  

Official title:

Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256159
• Other study ID #: 2023-02304
• Status: Recruiting
• Phase: N/A
• Start date: March 22, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: March 2024
• Source: University of Zurich
• Contact: Sabrina Imhof, PhD
• Phone: +41 44 510 72 17
• Email: sabrina.imhof[@]balgrist.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 67
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Multiple Sclerosis
• Nervous System Diseases
• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Other:
• 12 MSWS questionnaire
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.

Locations

Country	Name	City	State
Switzerland	Swiss Paraplegic Center	Nottwil
Switzerland	Balgrist University Hospital	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation, Swiss Paraplegic Research, Nottwil

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from day 1 to day 2
Primary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	Walking distance (m) and number of rests - 6MWT	High distance and low number of rests means better outcome.	Day 1
Secondary	Walking speed (m/s) - 10-meter walkint test (10MWT)	High speed means better outcome.	Day 1
Secondary	Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG)	The fewer seconds needed, the better the outcome.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 1
Secondary	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.	Day 2, maximum 8 weeks after day 1