Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Hasselt University
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- the Coordination test
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
This study will be a cross-sectional observational study, followed by a pilot intervention. The aim of the study is to examine the underlying causes of walking-related performance fatigability, together with other related and influencing factors, to make up a clinical profile of patients with MS showing walking-related performance fatigability. In the second part of the study a pilot intervention will be executed to see if the investigators can improve the clinical status of the MS patients with walking-related performance fatigability.
Investigators
Peter Feys
Principal Investigator
Hasselt University
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and 70 years.
- •MS diagnosis according to McDonald Criteria.
- •Capable of walking 6 minutes (independent or with unilateral support) without stopping.
Exclusion Criteria
- •Exacerbation or relapse within last 3 months before study
- •Other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, Parkinson).
Outcomes
Primary Outcomes
the Coordination test
Time Frame: Day 1
Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.
TST (Triple Stimulation Technique)
Time Frame: day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
TMS (Transcranial Magnetic Stimulation)
Time Frame: Day 3
Technique in which nerves are stimulated to check guidance in the central nervous system
Motor function test (lower limb muscle strength)
Time Frame: week 11
This is a motor test to assess the functional lower limb muscle strength. The participant is asked to stand from a seated position and sit down again as fast as possible for five times in a row.
Nine Hole Peg Test (NHPT)
Time Frame: week 11
This is a motor test to assess the participant's manual skills. This test records the time the participant needs to place 9 pins in the pegboard and remove them again.
Activity tracker
Time Frame: Up to 5 days
A sensor will be placed around the foot and worn by the participant for 5 days and nights to evaluate physical activity and quality of sleep.
the Digit Span
Time Frame: Week 11
Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
the Stroop test
Time Frame: week 11
Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)
Time Frame: week 11
his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds
Glycocheck
Time Frame: Baseline
A small camera will be placed under the tongue of the participant and blood vessels will be filmed to determine the quality of the blood vessels and immunity.
the Voluntary Drive test
Time Frame: Day 1
The participant is seated in a Biodex. While performing a leg extension the Quadriceps muscle is stimulated to check the guidance of electrical signals to the muscles.
the Fatigability Index Legs
Time Frame: Day 1
Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.
Analysis of a Muscle Biopsy
Time Frame: Day 3
A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.
25 Foot Walk (T25FW) test
Time Frame: week 11
his is a motor test at which the participant is instructed to walk 25 ft (=7,62 meter) as fast and safely as possible. This is a quantitative performance test to assess mobility and leg function.
Six minute walking test
Time Frame: once during the observational study
Participant have to walk as far as they can for 6 minutes. Total distance walked and fatigability by comparing first and last minute distance will be calculated.
the Paced Auditory Serial Addition Test (PASAT)
Time Frame: Week 11
This is a cognitive test where the participant will try to retain certain numbers they hear and do math. Correct answer last 1/3 vs first 1/3
Fatigability Index Hand
Time Frame: week 11
Grip strength will be evaluated through a Jamar dynamometer.
Secondary Outcomes
- Fatigue Scale of Motor and Cognitive Functions (FSMC)(week 11)
- Social Role Participation Questionnaire (SRPQ)(week 11)
- pre-interventionMSWS-12 score(week 11)
- Modified Fatigue Impact Scale (MFIS)(week 11)
- post-interventionMSWS-12 score(week 11)
- Multiple Sclerosis Impact Scale (MSIS-29)(week 11)
- Short Form Health survey (SF-36)(week 11)
- Fatigue severity scale (FSS)(week 11)
- The Sleep Condition Indicator (SCI)(week 11)
- Hospital Anxiety and Depression Scale (HADS)(Week 11)