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

NCT06256159 | Completed

• 1 other identifier: 2023-02304
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Outcome Measures

Primary Outcomes (2)

• 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 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

  Day 1

• Walking impairment (numeric value from 0-20) - WISCI II

  Day 1

• Walking distance (m) and number of rests - 6MWT

  Day 1

• Walking speed (m/s) - 10-meter walkint test (10MWT)

  Day 1

• Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG)

  Day 1

Study Arms (1)

Patients with incomplete spinal cord injury

OTHER

Other: 12 MSWS questionnaire

Interventions

12 MSWS questionnaire OTHER

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.

Patients with incomplete spinal cord injury

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator
• Swiss Paraplegic Research, Nottwil: collaborator

Study Sites (2)

Swiss Paraplegic Center

Nottwil, 6207, Switzerland

Location

Balgrist University Hospital

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Björn Zörner, PD Dr.

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 13, 2024
• Study Start: March 22, 2024
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CH (2)