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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04856345
• Other study ID #: B1152020000021
• Status: Completed
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Walking with music with synchronisation
Walking with music than one can synch to
• Walking with music without synchronisation
Walking with music than one cannot synch to
• walking without music
Walking without music

Locations

Country	Name	City	State
Belgium	Noorderhart Revalidatie & MS centrum	Overpelt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Revalidatie & MS Centrum Overpelt

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	6 minutes walking test to calculate the distance walking Index	impact of MS on walking	Baseline
Primary	6 minutes walking test to calculate the distance walking Index	impact of MS on walking	week 5
Primary	12 minute walking with sensors	gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters	Baseline
Primary	12 minute walking with sensors	gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters	week 5
Secondary	Paced auditory serial addition test and symbol digit modality test	to measure cognitive functioning and cognitive fatigability	Baseline
Secondary	Paced auditory serial addition test and symbol digit modality test	to measure cognitive functioning and cognitive fatigability	week 5
Secondary	Motricity Index of dorsi flexors, knee extensors and hip flexors	Muscle weakness	Baseline
Secondary	Motricity Index of dorsi flexors, knee extensors and hip flexors	Muscle weakness	week 5
Secondary	Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	Spasticity	Baseline
Secondary	Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	Spasticity	week 5
Secondary	Scale for the assessment and rating of ataxia	Ataxia	Baseline
Secondary	Scale for the assessment and rating of ataxia	Ataxia	week 5
Secondary	Dynamic gait index	Dynamic balance	Baseline
Secondary	Dynamic gait index	Dynamic balance	week 5
Secondary	Time up and Go test	balance	Baseline
Secondary	Time up and Go test	balance	week 5
Secondary	Modified fatigue impact scale	self-reported outcomes for fatigue	Baseline
Secondary	Modified fatigue impact scale	self-reported outcomes for fatigue	week 5
Secondary	Barcelona music reward questionnaire	experience of music reward	Baseline
Secondary	Barcelona music reward questionnaire	experience of music reward	week 5
Secondary	Hospital anxiety and depression questionnaire	anxiety and depression	Baseline
Secondary	Hospital anxiety and depression questionnaire	anxiety and depression	week 5
Secondary	Activities-specific balance confidence scale	self-reported outcome for activity and balance	Baseline
Secondary	Activities-specific balance confidence scale	self-reported outcome for activity and balance	week 5
Secondary	Stroke rehabilitation motivation scale	self-reported motivation questionnaire	Baseline
Secondary	Stroke rehabilitation motivation scale	self-reported motivation questionnaire	week 5
Secondary	the Brunnel Music Rating Inventory-2	self-reported music rating inventory	Baseline
Secondary	the Brunnel Music Rating Inventory-2	self-reported music rating inventory	week 5
Secondary	credibility and expectations questionnaire	self-reporting of credibility of the intervention.	week 5
Secondary	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