Multiple Sclerosis Clinical Trial
Official title:
Effect of Motor Entrainment to Auditory Cues and Music During Walking on Quality of Movement and Percieved Fatigue in Persons With Multiple Sclerosis With Cerebellar Lesions
This study is a case-control observational study, involving persons with multiple sclerosis and healthy controls. The study contains 1 descriptive and 4 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, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.
Status | Recruiting |
Enrollment | 8 |
Est. completion date | December 31, 2025 |
Est. primary completion date | September 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - diagnosis of Multiple sclerosis >1 year, - type of lesions: cerebellar lesions, - 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | National MS Center Melsbroek | Melsbroek | |
Belgium | Noorderhart Revalidatie & MS centrum | Overpelt |
Lead Sponsor | Collaborator |
---|---|
Hasselt University | National MS Center Melsbroek, Revalidatie & MS Centrum Overpelt |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resultant Vector Length | synchronisation consistency | week 3 | |
Primary | Resultant Vector Length | synchronisation consistency | week 4 | |
Primary | Resultant Vector Length | synchronisation consistency | week 5 | |
Primary | Relative phase angle | asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively) | week 3 | |
Primary | Relative phase angle | asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively) | week 4 | |
Primary | Relative phase angle | asynchrony in time to quantify synchronization accuracy (in degrees and in milliseconds respectively) | week 5 | |
Primary | Perceptual tempo and rhythm judgements | subjective indications in regards to what the participants hear in terms | week 2 | |
Primary | Asynchrony | timing difference between the tap and the beat | week2 | |
Primary | EEG | 64 channel EEG measurement (only conducted in 4 PwMS and HC) -> neural correlates of entrainment | week 2 | |
Primary | Muscle weakness | Motricity Index of dorsi flexors, knee extensors and hip flexors - | week 1 | |
Primary | Spasticity | Modified Aschowrth scale Hamstrings, Tricepts Surae, Quadricepts | week 1 | |
Primary | Ataxia | Scale for the assessment and rating of ataxia | week 1 | |
Primary | Dynamic gait index | dynamic balance | week 1 | |
Primary | Time up and Go test | balance | week 1 | |
Primary | 6 minute walking test | gait pattern and endurance | week 1 | |
Primary | Brief repeatable battery of Rao | cognitive test | week 1 | |
Primary | Symbol digit mobility test | cognitive test | week 1 | |
Primary | Stroop test 0 | cognitive test | week 1 | |
Primary | MS walking scale -12 | impact of MS on walking ability | week 1 | |
Primary | Activities-specific balance confidence scale | rating of balance confidence in performing activities of daily life | week 1 | |
Primary | Modified fatigue impact scale | effect of fatigue | week 1 | |
Primary | Hospital Anxiety and Depression Scale | determine the levels of anxiety and depression | week 1 | |
Primary | Dual task questionnaire | troubles a person have when performing a dual task during daily activity | week 1 | |
Secondary | Cadence | number of steps per minute | week 3 | |
Secondary | Cadence | number of steps per minute | week 4 | |
Secondary | Cadence | number of steps per minute | week 5 | |
Secondary | Stride length | distance between consecutive steps (cm) | week 3 | |
Secondary | Stride length | distance between consecutive steps (cm) | week 4 | |
Secondary | Stride length | distance between consecutive steps (cm) | week 5 | |
Secondary | speed | gait velocity (m/s) | week 3 | |
Secondary | speed | gait velocity (m/s) | week 4 | |
Secondary | speed | gait velocity (m/s) | week 5 | |
Secondary | Double Support | time that both legs are in contact with the floor (mseconds) | week 3 | |
Secondary | Double Support | time that both legs are in contact with the floor (mseconds) | week 4 | |
Secondary | Double Support | time that both legs are in contact with the floor (mseconds) | week 5 | |
Secondary | 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 | |
Secondary | 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 4 | |
Secondary | 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 5 | |
Secondary | 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 | |
Secondary | 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 4 | |
Secondary | 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 5 | |
Secondary | 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 | |
Secondary | 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 4 | |
Secondary | 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 5 |
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