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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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04887753
Enrollment
80
Registered
2021-05-14
Start date
2021-04-29
Completion date
2025-12-31
Last updated
2024-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebellar Lesions

Brief summary

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.

Interventions

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.

Sponsors

CHU de Charleroi
CollaboratorOTHER
Hôpital Universitaire de Bruxelles (HUB) Erasme
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Relative phase angleweek 2asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively)
6 minute walking testbaselinegait pattern and endurance
cerebellar affective syndrome testbaselinecognitive test
Scale for the assessment and rating of ataxiabaselineataxia
Activities-specific balance confidence scalebaselinerating of balance confidence in performing activities of daily life
Modified fatigue impact scalebaselineeffect of fatigue
Perceptual tempo and rhythm judgementsweek 1subjective indications in regards to what the participants hear in terms
Asynchronyweek 1timing difference between the tap and the beat
64 channel EEG measurementweek 1neural correlates of entrainment
Resultant Vector Lengthweek 1synchronisation consistency
Time up and Go testbaselineBalance
Hospital Anxiety and Depression Scalebaselinedetermine the levels of anxiety and depression
Dual task questionnairebaselinetroubles a person have when performing a dual task during daily activity
Motricity Index of dorsi flexors, knee extensors and hip flexorsbaselineMuscle weakness
Dynamic gait indexbaselinedynamic balance
Modified Aschowrth scale Hamstrings, Tricepts Surae, QuadriceptsbaselineSpasticity

Secondary

MeasureTime frameDescription
Speedweek 2gait velocity (m/s)
Double Supportweek 2time that both legs are in contact with the floor (mseconds)
Cadencceweek 2number of steps per minute
Stride lengthweek 2distance between consecutive steps (cm)
Perceived cognitive and physical fatigueweek 2A 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
Perceived motivationweek 2A Likert scale will be used, and participants will be asked to rate their perceived motivation of walking after each experimental walking conditions
Perceived walking speedweek 2A 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
64 channel EEG measurement (only conducted in 4 PwMS and HC)week 2Neural correlates of entrainment

Countries

Belgium

Contacts

Primary ContactPeter Feys, prof. dr.
peter.feys@uhasselt.be+32 11 29 21 23
Backup Contactlousin Moumdjian, dr.
lousin.moumdjian@uhasselt.be+32 11 26 93 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026