Running Title: Walking to Music and in Silence on a Treadmill

NCT ID: NCT04856345

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2023-12-31

Brief Summary

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This work is embedded in the context of auditory-motor coupling, which entails the engagement of two systems; the interaction between the music (or repetitive auditory stimuli) and a walking individual (repetitive movements of footfall). In previous studies, the investigators have shown that synchronising steps to beats in music have shown to be feasible in persons with multiple sclerosis, showing increase of step frequency and reduced perceived fatigue\[1, 2\]. In this current work, The investigators expand previous findings with a pilot intervention study, to investigate if synchronisation is necessary to improve cognitive and motor functions.

The proposed experiment includes 30 participants, randomised to three arms of a pilot intervention (10 participants per arm). With the intention of a further case-study analysis, the inestigators request to include 4 additional participants (2 PwMS with cognitive impairment, and 2 persons with cerebellar lesion) to only follow the intervention arm 1.

Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Music with synchronising

walking to music that one can synchronise to

Group Type EXPERIMENTAL

Walking with music with synchronisation

Intervention Type OTHER

Walking with music than one can synch to

Music without synchronising

walking to music that one cannot synchronise to

Group Type ACTIVE_COMPARATOR

Walking with music without synchronisation

Intervention Type OTHER

Walking with music than one cannot synch to

No music

walking without music.

Group Type SHAM_COMPARATOR

walking without music

Intervention Type OTHER

Walking without music

Interventions

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Walking with music with synchronisation

Walking with music than one can synch to

Intervention Type OTHER

Walking with music without synchronisation

Walking with music than one cannot synch to

Intervention Type OTHER

walking without music

Walking without music

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* A diagnosis of MS if \>1,
* no relapses \>1 month,
* ability to walk for 12minutes,
* ability to walk independently on a treadmill
* walking speed between 0.8-1.2m/s.

Exclusion Criteria

* amusia,
* deafness,
* cognitive impairment hindering understanding of study instructions,
* pregnancy.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Revalidatie & MS Centrum Overpelt

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Peter Feys

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Feyse, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Lousin Moumdjian, dr.

Role: STUDY_CHAIR

Hasselt University

Locations

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Noorderhart Revalidatie & MS centrum

Overpelt, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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B1152020000021

Identifier Type: -

Identifier Source: org_study_id

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