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Clinical Trials/NCT04856345
NCT04856345
Completed
Not Applicable

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

Hasselt University1 site in 1 country5 target enrollmentJanuary 22, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Hasselt University
Enrollment
5
Locations
1
Primary Endpoint
12- item multiple sclerosis walking scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 22, 2021
End Date
December 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Peter Feys

Principal Investigator

Hasselt University

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

12- item multiple sclerosis walking scale

Time Frame: 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

Time Frame: week 5

gait dynamics and pattern - detrended fluctuation analysis and spatio-temporal parameters

6 minutes walking test to calculate the distance walking Index

Time Frame: week 5

impact of MS on walking

Secondary Outcomes

  • Paced auditory serial addition test and symbol digit modality test(week 5)
  • Motricity Index of dorsi flexors, knee extensors and hip flexors(week 5)
  • Dynamic gait index(week 5)
  • Scale for the assessment and rating of ataxia(week 5)
  • Time up and Go test(week 5)
  • Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts(week 5)
  • Hospital anxiety and depression questionnaire(week 5)
  • Barcelona music reward questionnaire(week 5)
  • Modified fatigue impact scale(week 5)
  • Activities-specific balance confidence scale(week 5)
  • credibility and expectations questionnaire(week 5)
  • Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks(up to week 4)
  • Stroke rehabilitation motivation scale(week 5)
  • the Brunnel Music Rating Inventory-2(week 5)

Study Sites (1)

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