Clinical trial NCT06256159: Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury
Official title: Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Gait Disorders, Neurologic
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Swiss Paraplegic Research, Nottwil
First posted: 2024-02-13
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: Change from day 1 to day 2
measure: Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.
timeFrame: Day 1
Secondary outcomes:
measure: Clinical examination (a neurological examination including the ASIA score (categoric outcome grade A-E) - International Standards for Neurological Classification of Spinal Cord Injury
timeFrame: Day 1
measure: Walking impairment (numeric value from 0-20) - WISCI II
timeFrame: Day 1
measure: Walking distance (m) and number of rests - 6MWT
timeFrame: Day 1
measure: Walking speed (m/s) - 10-meter walkint test (10MWT)
timeFrame: Day 1
measure: Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG)
timeFrame: Day 1
measure: Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17
timeFrame: Day 1
measure: Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA)
timeFrame: Day 1
measure: Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview
timeFrame: Day 2, maximum 8 weeks after day 1
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Center
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: University of Zurich
name: Björn Zörner, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: