NCT02737904

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 14, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

12 months

First QC Date

April 4, 2016

Last Update Submit

August 18, 2017

Conditions

Multiple Sclerosis

Keywords

Muscle spasticity

Outcome Measures

Primary Outcomes (1)

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

    Score on Multiple Sclerosis Spasticity Scale (MSSS-88)

    Change from Baseline at 4 weeks

Secondary Outcomes (8)

  • Spasticity scored on Modified Ashworth Scale (MAS)

    Change from Baseline at 4 weeks

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

    Change from Baseline at 4 weeks

  • Function - FIM

    Change from Baseline at 4 weeks

  • Function - T25FW

    Change from Baseline at 4 weeks

  • Quality of Life (MSQOL)-54 scale

    Change from Baseline at 4 weeks

  • +3 more secondary outcomes

Study Arms (2)

Control group

ACTIVE COMPARATOR

Usual care - conventional, personalised in-patient rehabilitation 4 weeks duration

Other: Usual care

Intervention group

EXPERIMENTAL

Usual care - conventional, personalised in-patient rehabilitation - plus APT cycling programme 4 weeks duration

Other: APTOther: Usual care

Interventions

APTOTHER

APT for 30 minutes per day on 5 days per week for 4 weeks: 2 minute warm up consisting of passive cycling, where the legs of the participant are moved passively by the APT at 10 revolutions per min (rpm). Next, the participant will cycle for up to 26 minutes, at 60rpm. In this phase, the participant is required to actively cycle and to maintain a symmetrical pattern of movement using the feedback on the display. If the participant is unable to actively cycle at any point during the 26 minute exercise period, or if they have a spasm, the MOTOmed APT will revert to the passive mode. The final phase is a cool down where participants again will have 2 minutes of passive cycling at 10rpm.

Intervention group
Usual careOTHER

Personalised in-patient rehabilitation programme

Control groupIntervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physical Disability Rehabilitation Unit (PDRU), Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Multiple SclerosisMuscle Spasticity

Interventions

APT

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lorna Paul, BSc MPhil PhD

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

April 14, 2016

Study Start

August 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)