Effect of Variance on Error Correction During Coupling (Cerrebellar Lesions)

Understanding the Effect of Variances on Precision in Predictive Coding When Walking to Music and Metronomes in Persons With Cerrebellar Lesions

This study is a case-control study, involving persons with persons with cerebellar lesions 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebellar Lesions
• Intervention / Treatment: Other: Synchronisation abilities

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Feys, prof. dr.; Phone Number: +32 11 29 21 23; Email: peter.feys@uhasselt.be
• Study Contact Backup: Name: Lousin moumdjian, dr.; Phone Number: +32 11 26 93 71; Email: lousin.moumdjian@uhasselt.be

Study Locations

• Belgium
  • Lodelinsart, Belgium, 6042
    • Recruiting
    • Hôpital Civil Marie Curie
    • Contact: Mario Manto, prof. dr.; Phone Number: +32 11 26 93 71; Email: mmanto@ulb.ac.be
    • Contact: Pierre Cabaraux, dr.; Email: pierre.cabaraux@chu-charleroi.be
    • Principal Investigator: Mario Manto, prof. dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• diagnosis of cerrebellar lesions
• walking speed 0.8-1.2m/s, ability to walk for 6 minutes continuously (canes and rollators are permitted)

Exclusion Criteria:

• cognitive impairment impeding understanding of
• instructions,
• beat amusia,
• deafness,
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Healthy controls	Other: Synchronisation abilities; 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.
Experimental: persons with cerebellar lesions	Other: Synchronisation abilities; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motricity Index of dorsi flexors, knee extensors and hip flexors	Muscle weakness	baseline
Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts	Spasticity	baseline
Modified fatigue impact scale	effect of fatigue	baseline
Perceptual tempo and rhythm judgements	subjective indications in regards to what the participants hear in terms	week 1
Asynchrony	timing difference between the tap and the beat	week 1
64 channel EEG measurement	neural correlates of entrainment	week 1
Resultant Vector Length	synchronisation consistency	week 2
Resultant Vector Length	synchronisation consistency	week 3
Relative phase angle	asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)	week 2
Relative phase angle	asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)	week 3
Scale for the assessment and rating of ataxia	ataxia	baseline
Dynamic gait index	dynamic balance	baseline
Time up and Go test	Balance	baseline
6 minute walking test	gait pattern and endurance	baseline
cerebellar affective syndrome test	cognitive test	baseline
Activities-specific balance confidence scale	rating of balance confidence in performing activities of daily life	baseline
Hospital Anxiety and Depression Scale	determine the levels of anxiety and depression	baseline
Dual task questionnaire	troubles a person have when performing a dual task during daily activity	baseline
Resultant Vector Length	synchronisation consistency	week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cadencce	number of steps per minute	week 2
Cadencce	number of steps per minute	week 3
Stride length	distance between consecutive steps (cm)	week 2
Stride length	distance between consecutive steps (cm)	week 3
Speed	gait velocity (m/s)	week 2
Speed	gait velocity (m/s)	week 3
Double Support	time that both legs are in contact with the floor (mseconds)	week 2
Double Support	time that both legs are in contact with the floor (mseconds)	week 3
Perceived cognitive and physical fatigue	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	week 2
Perceived cognitive and physical fatigue	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	week 3
Perceived motivation	A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions	week 2
Perceived motivation	A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions	week 3
Perceived walking speed	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	week 2
Perceived walking speed	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	week 3
64 channel EEG measurement (only conducted in 4 PwMS and HC)	Neural correlates of entrainment	week 2
64 channel EEG measurement (only conducted in 4 PwMS and HC)	Neural correlates of entrainment	week 3

Collaborators and Investigators

• Sponsor: Hasselt University
• Collaborators: CHU de Charleroi; Erasme hospital
• Investigators: Principal Investigator: Peter Feys, prof. dr., Hasselt University; Study Chair: Lousin Moumdjian, dr., Hasselt University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2021
• Primary Completion (Estimated): September 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CL-Music-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No