Clinical trial NCT04856345: Running Title: Walking to Music and in Silence on a Treadmill
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Revalidatie & MS Centrum Overpelt
First posted: 2021-04-23
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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

Primary outcomes:
measure: 12- item multiple sclerosis walking scale
timeFrame: Baseline
measure: 12- item multiple sclerosis walking scale
timeFrame: week 5
measure: 6 minutes walking test to calculate the distance walking Index
timeFrame: Baseline
measure: 6 minutes walking test to calculate the distance walking Index
timeFrame: week 5
measure: 12 minute walking with sensors
timeFrame: Baseline
measure: 12 minute walking with sensors
timeFrame: week 5
Secondary outcomes:
measure: Paced auditory serial addition test and symbol digit modality test
timeFrame: Baseline
measure: Paced auditory serial addition test and symbol digit modality test
timeFrame: week 5
measure: Motricity Index of dorsi flexors, knee extensors and hip flexors
timeFrame: Baseline
measure: Motricity Index of dorsi flexors, knee extensors and hip flexors
timeFrame: week 5
measure: Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
timeFrame: Baseline
measure: Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts
timeFrame: week 5
measure: Scale for the assessment and rating of ataxia
timeFrame: Baseline
measure: Scale for the assessment and rating of ataxia
timeFrame: week 5
measure: Dynamic gait index
timeFrame: Baseline
measure: Dynamic gait index
timeFrame: week 5
measure: Time up and Go test
timeFrame: Baseline
measure: Time up and Go test
timeFrame: week 5
measure: Modified fatigue impact scale
timeFrame: Baseline
measure: Modified fatigue impact scale
timeFrame: week 5
measure: Barcelona music reward questionnaire
timeFrame: Baseline
measure: Barcelona music reward questionnaire
timeFrame: week 5
measure: Hospital anxiety and depression questionnaire
timeFrame: Baseline
measure: Hospital anxiety and depression questionnaire
timeFrame: week 5
measure: Activities-specific balance confidence scale
timeFrame: Baseline
measure: Activities-specific balance confidence scale
timeFrame: week 5
measure: Stroke rehabilitation motivation scale
timeFrame: Baseline
measure: Stroke rehabilitation motivation scale
timeFrame: week 5
measure: the Brunnel Music Rating Inventory-2
timeFrame: Baseline
measure: the Brunnel Music Rating Inventory-2
timeFrame: week 5
measure: credibility and expectations questionnaire
timeFrame: week 5
measure: Pre and Post training sessions, 2x a week, 20 minutes for 4 weeks
timeFrame: up to week 4
Other outcomes:
Locations:
city: Overpelt
country: Belgium
facility: Noorderhart Revalidatie & MS centrum
Study officials:
affiliation: Hasselt University
name: Peter Feyse, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Lousin Moumdjian, dr.
role: STUDY_CHAIR
References: