The Effect of Cycling Using Active-passive Trainers on Spasticity, Cardiovascular Fitness, Function and Quality of Life in People With Multiple Sclerosis

CompletedNot a drug-phase studyProgressive MSNCT02737904ISRCTN15999892

What it found

No results found

We found no results in the registry or in papers.

This trial finished 9 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • APT

Given to everyone in the trial

  • Usual care

What it measured

Main measures

  • Effect of spasticity on daily life scored on Multiple Sclerosis Spasticity Scale (MSSS-88)

    Change from Baseline at 4 weeks

    Spasticity
  • Effect of spasticity on aspects of daily life will be measured using the Multiple Sclerosis Spasticity Scale at baseline and 4 weeks

    Spasticity

Other measures (9)

  • Spasticity scored on Modified Ashworth Scale (MAS)

    Change from Baseline at 4 weeks

    Spasticity
  • Cardiovascular fitness calculated using Oxygen Uptake Efficiency Slope (OUES)

    Change from Baseline at 4 weeks

    Physical function
  • Function - FIM

    Change from Baseline at 4 weeks

  • Function - T25FW

    Change from Baseline at 4 weeks

    Disability progressionWalking and mobility
  • Quality of Life (MSQOL)-54 scale

    Change from Baseline at 4 weeks

    Quality of life (reported by participants)
  • APT cycling performance - symmetry

    Change from Baseline at 4 weeks

  • APT cycling performance - distance

    Change from Baseline at 4 weeks

  • APT cycling performance - power

    Change from Baseline at 4 weeks

  • 1. Spasticity will be measured using The Modified Ashworth Scale (MAS) at baseline and 4 weeks 2. Cardiovascular fitness will be measured using the oxygen uptake efficiency slope (OUES) at baseline and 4 weeks 3. Function will be assessed by the Functional Independence Measure (FIM) and the Timed 25-foot walk test (T25FW) at baseline and 4 weeks 4. Quality of Life will be measured with the MSQOL-5

    Disability progressionWalking and mobilityPhysical functionSpasticityQuality of life (reported by participants)

Who could take part

Progressive MS · 18 and over

Show the full criteria

Inclusion criteria

* have a confirmed diagnosis of progressive MS * are aged over 18 years * have an Expanded Disability Status Scale (EDSS) of between 6.5 (requires two walking aids - pair of canes, crutches, etc - to walk about 20m without resting) and 8.5 (essentially restricted to bed much of day); has some effective use of arms (retains some self care functions) and spasticity in their lower limbs (self reported)

Exclusion criteria

* cognitive impairment (cannot understand instructions) * other co-morbidities which would preclude them taking part in exercise * visual impairment (such that they cannot see the screen on the APT)

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

About this trial

In the sponsor's words

This randomised controlled trial aims to explore the effectiveness of a four week programme of exercise using lower limb Active Passive trainer (APT) (MOTOmed trainer) in terms of spasticity in people with moderate to severe Multiple Sclerosis.

Loading reviews and guidelines…

History

    1. Started

      Aug 2016

    2. Main results due

      Jul 2017

    3. Finished

      Jul 2017

    Assembled by software from public sources.