Validity and Reliability of the 12-item Multiple Sclerosis Walking Scale (12-WS) in Subjects with Spinal Cord Injury
- Conditions
- Spinal Cord InjuriesGait Disorders, Neurologic
- Interventions
- Other: 12 MSWS questionnaire
- Registration Number
- NCT06256159
- Lead Sponsor
- University of Zurich
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Patients with incomplete spinal cord injury 12 MSWS questionnaire -
- Primary Outcome Measures
Name Time Method Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI. Day 1 The scale is numeric and ranges from 0-100. A lower score means a better 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. Change from day 1 to day 2 The scale is numeric and ranges from 0-100. A lower score means a better outcome.
- Secondary Outcome Measures
Name Time Method Walking speed (m/s) - 10-meter walkint test (10MWT) Day 1 High speed means better outcome.
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 Grade "A" means most impaired, grade "E" means less impaired.
Walking impairment (numeric value from 0-20) - WISCI II Day 1 The scale is numeric and ranges from 0-20. A higher score means a better outcome.
Walking distance (m) and number of rests - 6MWT Day 1 High distance and low number of rests means better outcome.
Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA) Day 1 The scale is numeric and ranges from 0-30). A higher score means a better outcome.
Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview Day 2, maximum 8 weeks after day 1 Only subjects with NO changes in impairment level will be used for reliability testing.
Walking speed including sit-stand transfer (s) - Timed Up and Go-test (TUG) Day 1 The fewer seconds needed, the better the outcome.
Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17 Day 1 The scale is numeric and ranges from 0-30). A higher score means a better outcome.
Trial Locations
- Locations (2)
Balgrist University Hospital
🇨🇭Zurich, Switzerland
Swiss Paraplegic Center
🇨🇭Nottwil, Switzerland