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

The Effect of a 4 Week Auditory-motor Coupling Intervention on Walking, Information Processing Speed and Fatigue in Persons With Multiple Sclerosis: Three Armed Pilot Intervention

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Walking with music with synchronisation; Other: Walking with music without synchronisation; Other: walking without music

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Overpelt, Belgium, 3900
    • Noorderhart Revalidatie & MS centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music with synchronising; walking to music that one can synchronise to	Other: Walking with music with synchronisation; Walking with music than one can synch to
Active Comparator: Music without synchronising; walking to music that one cannot synchronise to	Other: Walking with music without synchronisation; Walking with music than one cannot synch to
Sham Comparator: No music; walking without music.	Other: walking without music; Walking without music

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12- item multiple sclerosis walking scale	The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.	Baseline
12- item multiple sclerosis walking scale	The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.	week 5
6 minutes walking test to calculate the distance walking Index	impact of MS on walking	Baseline
6 minutes walking test to calculate the distance walking Index	impact of MS on walking	week 5
12 minute walking with sensors	gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters	Baseline
12 minute walking with sensors	gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters	week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paced auditory serial addition test and symbol digit modality test	to measure cognitive functioning and cognitive fatigability	Baseline
Paced auditory serial addition test and symbol digit modality test	to measure cognitive functioning and cognitive fatigability	week 5
Motricity Index of dorsi flexors, knee extensors and hip flexors	Muscle weakness	Baseline
Motricity Index of dorsi flexors, knee extensors and hip flexors	Muscle weakness	week 5
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	Spasticity	Baseline
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	Spasticity	week 5
Scale for the assessment and rating of ataxia	Ataxia	Baseline
Scale for the assessment and rating of ataxia	Ataxia	week 5
Dynamic gait index	Dynamic balance	Baseline
Dynamic gait index	Dynamic balance	week 5
Time up and Go test	balance	Baseline
Time up and Go test	balance	week 5
Modified fatigue impact scale	self-reported outcomes for fatigue	Baseline
Modified fatigue impact scale	self-reported outcomes for fatigue	week 5
Barcelona music reward questionnaire	experience of music reward	Baseline
Barcelona music reward questionnaire	experience of music reward	week 5
Hospital anxiety and depression questionnaire	anxiety and depression	Baseline
Hospital anxiety and depression questionnaire	anxiety and depression	week 5
Activities-specific balance confidence scale	self-reported outcome for activity and balance	Baseline
Activities-specific balance confidence scale	self-reported outcome for activity and balance	week 5
Stroke rehabilitation motivation scale	self-reported motivation questionnaire	Baseline
Stroke rehabilitation motivation scale	self-reported motivation questionnaire	week 5
the Brunnel Music Rating Inventory-2	self-reported music rating inventory	Baseline
the Brunnel Music Rating Inventory-2	self-reported music rating inventory	week 5
credibility and expectations questionnaire	self-reporting of credibility of the intervention.	week 5
Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks	Before and after each training session; Perceived cognitive and physical fatigue rated on a visual analogue scale; Perceived motivation rated on a Likert scale	up to week 4

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: Revalidatie & MS Centrum Overpelt
• Investigators: Principal Investigator: Peter Feyse, prof. dr., Hasselt University; Study Chair: Lousin Moumdjian, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 23, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: B1152020000021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No