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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04856345
Enrollment
5
Registered
2021-04-23
Start date
2021-01-22
Completion date
2023-12-31
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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.

Interventions

OTHERWalking with music with synchronisation

Walking with music than one can synch to

OTHERWalking with music without synchronisation

Walking with music than one cannot synch to

OTHERwalking without music

Walking without music

Sponsors

Revalidatie & MS Centrum Overpelt
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
12- item multiple sclerosis walking scaleBaselineThe 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.
6 minutes walking test to calculate the distance walking IndexBaselineimpact of MS on walking
12 minute walking with sensorsBaselinegait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters

Secondary

MeasureTime frameDescription
Scale for the assessment and rating of ataxiaBaselineAtaxia
Dynamic gait indexBaselineDynamic balance
Time up and Go testBaselinebalance
Modified fatigue impact scaleBaselineself-reported outcomes for fatigue
Barcelona music reward questionnaireBaselineexperience of music reward
Paced auditory serial addition test and symbol digit modality testBaselineto measure cognitive functioning and cognitive fatigability
Activities-specific balance confidence scaleBaselineself-reported outcome for activity and balance
Stroke rehabilitation motivation scaleBaselineself-reported motivation questionnaire
the Brunnel Music Rating Inventory-2Baselineself-reported music rating inventory
credibility and expectations questionnaireweek 5self-reporting of credibility of the intervention.
Pre and Post training sessions, 2x a week, 20 minutes for 4 weeksup to week 4Before and after each training session * Perceived cognitive and physical fatigue rated on a visual analogue scale * Perceived motivation rated on a Likert scale
Hospital anxiety and depression questionnaireBaselineanxiety and depression
Motricity Index of dorsi flexors, knee extensors and hip flexorsBaselineMuscle weakness
Modified Aschowrth scale Hamstrings, Tricepts Surae, QuadriceptsBaselineSpasticity

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026