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Completed

NCT Number: NCT06256159

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Swiss Paraplegic Center, Nottwil, Switzerland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: Change from day 1 to day 2

    The scale is numeric and ranges from 0-100. A lower score means a better outcome.

  2. Validity of the 12-item Multiple Sclerosis Walking Scale (12-WS) in subjects with incomplete SCI.

    Time frame: Day 1

    The scale is numeric and ranges from 0-100. A lower score means a better outcome.

Secondary outcomes

  1. Clinical examination (a neurological examination including the ASIA score (categoric outcome grade A-E) - International Standards for Neurological Classification of Spinal Cord Injury

    Time frame: Day 1

    Grade "A" means most impaired, grade "E" means less impaired.

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

    Time frame: Day 1

    The scale is numeric and ranges from 0-20. A higher score means a better outcome.

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

    Time frame: Day 1

    High distance and low number of rests means better outcome.

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

    Time frame: Day 1

    High speed means better outcome.

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

    Time frame: Day 1

    The fewer seconds needed, the better the outcome.

  6. Functional independence (numeric value from 0-40) - Spinal Cord Independence Measure III (SCIM III), Items 9-17

    Time frame: Day 1

    The scale is numeric and ranges from 0-30). A higher score means a better outcome.

  7. Dynamic balance (numeric value from 0-30) - Functional Gait Assessment (FGA)

    Time frame: Day 1

    The scale is numeric and ranges from 0-30). A higher score means a better outcome.

  8. Change in impairment level (nominal outcome Yes - No) - Follow up questions in telephone interview

    Time frame: Day 2, maximum 8 weeks after day 1

    Only subjects with NO changes in impairment level will be used for reliability testing.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Swiss National Science Foundation
  • Swiss Paraplegic Research, Nottwil

Registry information

Acronym: 12-WS SCI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 13, 2024
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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