NCT03281330

Brief Summary

The study investigates the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls. The study extends over a four session period, each session lasting maximally 1h30 minutes The experimental conditions include participants walking to music and metronome (at different tempi) for 3minutes and 15 seconds per condition, with a rest period of 3 minutes in between each condition. Non-invasive equipment will be used. participants are equipped with sensors (watch-like straps at the wrists, ankles and across the chest) and are given wireless headphones.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

September 11, 2017

Last Update Submit

August 2, 2018

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (8)

  • Spatio-temporal parameters of gait

    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

    day 1

  • Spatio-temporal parameters of gait

    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

    week 1

  • Spatio-temporal parameters of gait

    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

    week 2

  • Spatio-temporal parameters of gait

    Participants wear portable APDM sensors. These sensors are activated during the walking, and record the spatio-temporal parameters of gait.

    week 3

  • Parameter's of sychronisation

    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

    day 1

  • Parameter's of sychronisation

    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

    week 1

  • Parameter's of sychronisation

    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

    week 2

  • Parameter's of sychronisation

    Participants have two light ipods attached on their ankles- these are a part of the D-jogger system. The system is activated during the walking, and logs the synchronization parameters

    week 3

Secondary Outcomes (8)

  • subjective physical /mental fatigue

    day 1

  • subjective physical /mental fatigue

    week 1

  • subjective physical /mental fatigue

    week 2

  • physical /mental fatigue

    week 3

  • motivation

    day 1

  • +3 more secondary outcomes

Study Arms (2)

persons with Multiple Sclerosis

Behavioral: auditory cues and music during walking

Healthy controls

Behavioral: auditory cues and music during walking

Interventions

auditory cues and music during walkingBEHAVIORAL

the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls

Healthy controlspersons with Multiple Sclerosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

persons with Multiple Sclerosis and healthy volonteers

You may qualify if:

  • diagnosis of MS of \>1 year,
  • no relapse in the last 1 month,
  • ability to walk for 12 minutes without interruption,
  • an average usual walking speed between the range of 0.4 and 1.2 m/s.

You may not qualify if:

  • cognitive impairment hindering the understanding and execution of the experimental procedures
  • pregnancy
  • hearing impairment
  • amusia
  • beat deafness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Ghent

Ghent, Belgium

Location

Nationaal Multiple Sclerose Center

Melsbroek, Belgium

Location

Revalidatie & MS Centrum Overpelt

Overpelt, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

February 1, 2017

Primary Completion

May 30, 2018

Study Completion

June 30, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

BE(3)