Underlying Causes and Related Factors, and Rehabilitation Approaches
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Training intervention + Dance intervention
- Registration Number
- NCT04142853
- Lead Sponsor
- Hasselt University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Age between 18 and 70 years.
- MS diagnosis according to McDonald Criteria.
- Capable of walking 6 minutes (independent or with unilateral support) without stopping.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Persons with MS, dance group Training intervention + Dance intervention - Persons with MS, art group Training intervention + Dance intervention -
- Primary Outcome Measures
Name Time Method TST (Triple Stimulation Technique) day 3 Technique in which nerves are stimulated to check guidance in the central nervous system
the Coordination test 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.
TMS (Transcranial Magnetic Stimulation) Day 3 Technique in which nerves are stimulated to check guidance in the central nervous system
Motor function test (lower limb muscle strength) 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) 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 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 Week 11 Cognitive test where numbers must be recalled in a certain order to evaluate short term memory
the Stroop test week 11 Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.
the Symbol Digit Modality Test (SDMT) (Cognitive fatigability) 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 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 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 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 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 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 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) 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 week 11 Grip strength will be evaluated through a Jamar dynamometer.
- Secondary Outcome Measures
Name Time Method Fatigue Scale of Motor and Cognitive Functions (FSMC) week 11 This is a short questionnaire to cognitive and motor fatigue in people with MS. The FSMC is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). Two subscales (mental and physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-10-12-14-16-19.
Social Role Participation Questionnaire (SRPQ) week 11 This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5 (very important)
pre-interventionMSWS-12 score week 11 short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.Modified Fatigue Impact Scale (MFIS) week 11 This is a short questionnaire to evaluate to impact of general fatigue. This questionnaire measures the effects of fatigue on three levels: physical, cognitive and psychosocial.The MFIS is a 21-item questionaire, scale 0 (never)-4 (always), scale range 0-40
post-interventionMSWS-12 score week 11 short questionnaire to map out walking difficulties in daily living. The Multiple Sclerosis Walking Scale is a self-assessment scale which measures the impact of MS on walking. It consists of 12 questions concerning the limitations to walking due to MS during the past 2 weeks. Each item can be answered with 5 options, with 1 meaning no limitation and 5 extreme limitation.
A total score can be generated and transformed to a 0 to 100 scale by subtracting the minimum score possible (12) from the patient's score, dividing by the maximum score possible minus the minimum possible (60-12 or 48), and multiplying the result by 100. Walking improvement on the MSWS-12 is indicated by negative change scores.Multiple Sclerosis Impact Scale (MSIS-29) week 11 This is a short self-report questionnaire used to assess the day-to-day life in the past two weeks. This questionnaire has a physical and psychological scale. The MSIS-29 is a 29-item self-report measure with 20 items associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 5 response options: 1 "not at all" to 5"extremely". Each of the two scales are scored by summing the responses across items, then converting to a 0-100 scale where 100 indicates greater impact of disease on daily function (worse health).
The physical impact score is computed by summing items number 1-20 inclusive. This score can then be transformed to a score on a scale of 0 -100Short Form Health survey (SF-36) week 11 questionnaire to measure health status. The Optum® SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view. It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes.
Fatigue severity scale (FSS) week 11 A self-report scale of nine items about fatigue, its severity and how it affects certain activities. Answers are scored on a seven point scale where 1 = strongly disagree and 7 = strongly agree. This means the minimum score possible is nine and the highest is 63. The higher the score, the more severe the fatigue is and the more it affects the person's activities. It is simple to understand and takes an average of eight minutes to answer
Hospital Anxiety and Depression Scale (HADS) Week 11 This is a short questionnaire that evaluates symptoms of anxiety and depression in daily life. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression.
The Sleep Condition Indicator (SCI) week 11 This is a short questionnaire to evaluate sleeping pattern and potential sleeping disorders. The Sleep Condition Indicator (SCI) is an eight-item rating scale (4-0) that was developed to screen for insomnia disorder based on DSM-5 criteria.
Trial Locations
- Locations (2)
Hasselt University
🇧🇪Hasselt, Belgium
Centre Hospitalier Universitaire de Liège
🇧🇪Liège, Belgium