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

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 Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries; Gait Disorders, Neurologic
• Intervention / Treatment: Other: 12 MSWS questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 67
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabrina Imhof, PhD; Phone Number: +41 44 510 72 17; Email: sabrina.imhof@balgrist.ch
• Study Contact Backup: Name: Sybille Achermann, SC; Email: sybille.achermann@balgrist.ch

Study Locations

• Switzerland
  • Nottwil, Switzerland, 6207
    • Recruiting
    • Swiss Paraplegic Center
    • Contact: Sabrina Imhof, MSc; Email: sabrina.imhof@balgrist.ch
    • Contact: Sibylle Achermann, SC; Email: sibylle.achermann@balgrist.ch
  • Zurich, Switzerland, 8008
    • Recruiting
    • Balgrist University Hospital
    • Contact: Sibylle Achermann, SC; Email: sibylle.achermann@balgrist.ch
    • Contact: Sabrina Imhof, MSc; Phone Number: +41 44 510 72 17; Email: sabrina.imhof@balgrist.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patients with incomplete spinal cord injury	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Swiss National Science Foundation; Swiss Paraplegic Research, Nottwil
• Investigators: Principal Investigator: Björn Zörner, PD Dr., University of Zurich

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 19, 2024
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Multiple Sclerosis; Wounds and Injuries; Nervous System Diseases; Spinal Cord Injuries; Gait Disorders, Neurologic
• Other Study ID Numbers: 2023-02304

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No