Validity and Reliability of the 12-item Multiple Sclerosis Walking Sca

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

CompletedNot a drug-phase studyMS (type not specified)NCT06256159

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 20 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • 12 MSWS questionnaire

What it measured

Main measures

  • 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

    Walking and mobility

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

    Day 1

    Walking and mobility

Other measures (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 and mobility

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

    Day 1

    Walking and mobility

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

    Day 1

    Walking and mobility

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

    Day 1

    Walking and mobility

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

    Day 1

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

    Day 1

    Walking and mobility

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

    Day 2, maximum 8 weeks after day 1

Who could take part

MS (type not specified) · 18 to 80

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Mar 2024

    2. Main results due

      Mar 2025

    3. Finished

      Mar 2025

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