Effect of Variance on Error Correction During Coupling

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Progressive Multiple Sclerosis
• Interventions: Other: synchronisation abilities

• Registration Number: NCT04856384
• Lead Sponsor: Hasselt University

Brief Summary

This study is a case-control study, involving persons with progressive multiple sclerosis and healthy controls. The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations. In the latter twp sessions, apart from outcome measures of synchronization the following will be collected as well: brain activity using EEG recordings, spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-29
• Study Start: 2021-02-01
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-23
• Status Verified: 2024-04
• Primary Completion: 2024-10-22
• Study Completion: 2024-12-31
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• diagnosis of Multiple sclerosis >1 year, diagnosis of progressive MS,
• walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)

Exclusion Criteria

• relapse 3 months prior to enrollment,
• cognitive impairment impeding understanding of instructions,
• beat amusia,
• deafness,
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
persons with Multiple Sclerosis	synchronisation abilities	-
Healthy controls	synchronisation abilities	-

Primary Outcome Measures

Name	Time	Method
Motricity Index of dorsi flexors, knee extensors and hip flexors	baseline	Muscle weakness
6 minute walking test	Baseline	gait pattern and endurance
Hospital Anxiety and Depression Scale	Baseline	determine the levels of anxiety and depression
Scale for the assessment and rating of ataxia	Baseline	ataxia
Brief repeatable battery of Rao	Baseline	cognitive test
Symbol digit mobility test	Baseline	cognitive test
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	baseline	Spasticity
MS walking scale -12	Baseline	impact of MS on walking ability
Dual task questionnaire	Baseline	troubles a person have when performing a dual task during daily activity
64 channel EEG measurement	week 1	neural correlates of entrainment
Relative phase angle	week 3	asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
Dynamic gait index	Baseline	dynamic balance
Time up and Go test	Baseline	Balance
Stroop test 0	Baseline	cognitive test
Perceptual tempo and rhythm judgements	week 1	subjective indications in regards to what the participants hear in terms
Activities-specific balance confidence scale	Baseline	rating of balance confidence in performing activities of daily life
Modified fatigue impact scale	baseline	effect of fatigue
Asynchrony	week 1	timing difference between the tap and the beat
Resultant Vector Length	week 3	synchronisation consistency

Secondary Outcome Measures

Name	Time	Method
Speed	week 3	gait velocity (m/s)
Perceived motivation	week 3	A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
Cadencce	week 3	number of steps per minute
Stride length	week 3	distance between consecutive steps (cm)
Perceived cognitive and physical fatigue	week 3	A visual analogue scale will be used, and participants will be asked to rate their perceived cognitive and physical fatigue levels before and after each experimental walking conditions
64 channel EEG measurement (only conducted in 4 PwMS and HC)	week 3	Neural correlates of entrainment
Double Support	week 3	time that both legs are in contact with the floor (mseconds)
Perceived walking speed	week 3	A Likert scale will be used, and participants will be asked to rate their perceived walking speed relative to their usual walking after each experimental walking conditions

Trial Locations

Locations (2)

National MS Center Melsbroek; 🇧🇪 Melsbroek, Belgium

Noorderhart Revalidatie & MS centrum; 🇧🇪 Overpelt, Belgium