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

Not Applicable

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Walking with music with synchronisation; Other: Walking with music without synchronisation; Other: walking without music

• Registration Number: NCT04856345
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-22
• Study First Submitted: 2021-02-02
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-23
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-24
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Music with synchronising	Walking with music with synchronisation	walking to music that one can synchronise to
Music without synchronising	Walking with music without synchronisation	walking to music that one cannot synchronise to
No music	walking without music	walking without music.

Primary Outcome Measures

Name	Time	Method
12- item multiple sclerosis walking scale	week 5	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.
12 minute walking with sensors	week 5	gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters
6 minutes walking test to calculate the distance walking Index	week 5	impact of MS on walking

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Noorderhart Revalidatie & MS centrum; 🇧🇪 Overpelt, Belgium