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

NCT04856345 | Completed

• 1 other identifier: B1152020000021
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (26)

• Paced auditory serial addition test and symbol digit modality test

  Baseline

• Paced auditory serial addition test and symbol digit modality test

  week 5

• Motricity Index of dorsi flexors, knee extensors and hip flexors

  Baseline

• Motricity Index of dorsi flexors, knee extensors and hip flexors

  week 5

• Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts

  Baseline

Study Arms (3)

Music with synchronising

EXPERIMENTAL

walking to music that one can synchronise to

Other: Walking with music with synchronisation

Music without synchronising

ACTIVE COMPARATOR

walking to music that one cannot synchronise to

Other: Walking with music without synchronisation

No music

SHAM COMPARATOR

walking without music.

Other: walking without music

Interventions

Walking with music with synchronisation OTHER

Walking with music than one can synch to

Music with synchronising

Walking with music without synchronisation OTHER

Walking with music than one cannot synch to

Music without synchronising

walking without music OTHER

Walking without music

No music

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• amusia,
• deafness,
• cognitive impairment hindering understanding of study instructions,
• pregnancy.

Sponsors & Collaborators

• Hasselt University: lead
• Revalidatie & MS Centrum Overpelt: collaborator

Study Sites (1)

Noorderhart Revalidatie & MS centrum

Overpelt, 3900, Belgium

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Walking

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Peter Feyse, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

• Lousin Moumdjian, dr.

  Hasselt University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: April 23, 2021
• Study Start: January 22, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

BE (1)