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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04856345
Other study ID # B1152020000021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2021
Est. completion date December 31, 2022

Study information

Verified date April 2021
Source Hasselt University
Contact Peter Feys, prof. dr.
Phone +32 11 29 21 23
Email peter.feys@uhasselt.be
Is FDA regulated No
Health authority
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 Recruiting
Enrollment 30
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
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.

Study Design


Related Conditions & MeSH terms


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 Noorderhart Revalidatie & MS

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
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