Underlying Causes and Related Factors, and Rehabilitation Approaches

Multiple Sclerosis Clinical Trial

Official title:

Walking-related Performance Fatigabitity in People With Multiple Sclerosis: Clinical Profile o

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04142853
• Other study ID #: B707201835771
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: May 2020
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Training intervention + Dance intervention
Training intervention + Dance intervention

Locations

Country	Name	City	State
Belgium	Hasselt University	Hasselt
Belgium	Centre Hospitalier Universitaire de Liège	Liège

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Coordination test	Participant is seated with legs strapped in to the mounts and moves legs to the beat of a metronome to assess central motor control.	Day 1
Primary	TST (Triple Stimulation Technique)	Technique in which nerves are stimulated to check guidance in the central nervous system	day 3
Primary	TMS (Transcranial Magnetic Stimulation)	Technique in which nerves are stimulated to check guidance in the central nervous system	Day 3
Primary	the Voluntary Drive test	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.	Day 1
Primary	the Fatigability Index Legs	Participant is seated in a Biodex and a protocol is performed to establish the muscle strength and muscle endurance of the legs.	Day 1
Primary	Analysis of a Muscle Biopsy	A small piece of muscle tissue of the weakest leg will be biopsied and analyzed in the lab.	Day 3
Primary	the Digit Span	Cognitive test where numbers must be recalled in a certain order to evaluate short term memory	Baseline
Primary	the Digit Span	Cognitive test where numbers must be recalled in a certain order to evaluate short term memory	Week 11
Primary	the Stroop test	Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.	Baseline
Primary	the Stroop test	Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.	week 11
Primary	the Paced Auditory Serial Addition Test (PASAT)	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	Baseline
Primary	the Paced Auditory Serial Addition Test (PASAT)	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	Week 11
Primary	the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)	his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds	Baseline
Primary	the Symbol Digit Modality Test (SDMT) (Cognitive fatigability)	his is a cognitive performance test, substantiated with focus, speed, and visual scanning. Correct answers last 30 seconds vs first 30 seconds	week 11
Primary	Motor function test (lower limb muscle strength)	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.	Baseline
Primary	Motor function test (lower limb muscle strength)	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.	week 11
Primary	25 Foot Walk (T25FW) test	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.	Baseline
Primary	25 Foot Walk (T25FW) test	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.	week 11
Primary	Nine Hole Peg Test (NHPT)	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.	Baseline
Primary	Nine Hole Peg Test (NHPT)	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.	week 11
Primary	Fatigability Index Hand	Grip strength will be evaluated through a Jamar dynamometer.	Baseline
Primary	Fatigability Index Hand	Grip strength will be evaluated through a Jamar dynamometer.	week 11
Primary	Activity tracker	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.	Up to 5 days
Primary	Glycocheck	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.	Baseline
Primary	Six minute walking test	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.	once during the observational study
Secondary	Fatigue severity scale (FSS)	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	baseline
Secondary	Fatigue severity scale (FSS)	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	week 11
Secondary	Modified Fatigue Impact Scale (MFIS)	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	baseline
Secondary	Modified Fatigue Impact Scale (MFIS)	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	week 11
Secondary	Fatigue Scale of Motor and Cognitive Functions (FSMC)	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.	baseline
Secondary	Fatigue Scale of Motor and Cognitive Functions (FSMC)	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.	week 11
Secondary	Hospital Anxiety and Depression Scale (HADS)	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..	baseline
Secondary	Hospital Anxiety and Depression Scale (HADS)	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.	Week 11
Secondary	The Sleep Condition Indicator (SCI)	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.	baseline
Secondary	The Sleep Condition Indicator (SCI)	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.	week 11
Secondary	Social Role Participation Questionnaire (SRPQ)	This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5(very important)	baseline
Secondary	Social Role Participation Questionnaire (SRPQ)	This is a short questionnaire to evaluate social participation. scale 1 (not important) - 5 (very important)	week 11
Secondary	pre-interventionMSWS-12 score	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.	baseline
Secondary	post-interventionMSWS-12 score	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.	baseline
Secondary	pre-interventionMSWS-12 score	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.	week 11
Secondary	post-interventionMSWS-12 score	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.	week 11
Secondary	Multiple Sclerosis Impact Scale (MSIS-29)	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 -100	Baseline
Secondary	Multiple Sclerosis Impact Scale (MSIS-29)	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 -100	week 11
Secondary	Short Form Health survey (SF-36)	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.	Baseline
Secondary	Short Form Health survey (SF-36)	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.	week 11