Psychometric Properties of Mobility, Beyond Walking Speed, in Multiple Sclerosis: a Multi-center Study.

CompletedNot a drug-phase studyMS (type not specified)NCT02339688

What it found

No results found

We found no results in the registry or in papers.

This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • conventional MS rehabilitation

What it measured

Main measures

  • Timed 25-Foot Walk test (T25FW)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Disability progressionWalking and mobility
  • Timed up and go (TUG), TUGcognitive

    day 1 and at the end of the rehabilitation, an expected average of three months

    Thinking and memoryWalking and mobility
  • Two minute walk test (2MWT)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Four Square Step Test (FSST)

    day 1 and at the end of the rehabilitation, an expected average of three months

  • 5 repetition sit-to-stand test (5STS-test)

    day 1 and at the end of the rehabilitation, an expected average of three months

  • Modified 5 repetition sit-to-stand test (mod 5STS-test)

    day 1 and at the end of the rehabilitation, an expected average of three months

  • Rivermead Mobility Index (RMI)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Multiple Sclerosis Walking Scale-12 (MSWS-12)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Performance Scale mobility (PS-mob)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility

Other measures (6)

  • Timed Up and Go, manual

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Berg Balance Scale (BBS)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Dynamic Gait index (DGI)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Activities-specific Balance Confidence Scale (ABC)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Walking and mobility
  • Trunk Impairment Scale, modified Norwegian version (TIS-modNV)

    day 1 and at the end of the rehabilitation, an expected average of three months

  • International Physical Activity Questionnaire (IPAQ)

    day 1 and at the end of the rehabilitation, an expected average of three months

    Physical function

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Diagnosis of MS according to McDonald criteria24, * Expanded Disability Status Scale25 (EDSS) ≥ 2 and ≤ 6.5 as determined by neurologists or trained clinician * no relapse within the last month * no changes in disease modifying treatment and no corticoid-therapy within the last month * receive at least 10 sessions of physical therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months

Exclusion criteria

* other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, …) * other neurological impairments with permanent damage (stroke, Parkinson, …) * MS-like syndromes such as neuromyelitis optica * not able to understand and execute simple instructions

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

About this trial

In the sponsor's words

Current study will investigate the quality (psychometric properties) and clinical utility of several mobility measures, according to disability level. Therefore, several aspects will be inquired: * Was there an effect of rehabilitation * Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness) * Does the measure assess what it claims to measure (validity) * Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects) * Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels. Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).

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History

    1. Started

      Oct 2014

    2. Main results due

      Dec 2015

    3. Finished

      Jun 2016

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