Underlying Causes and Related Factors, and Rehabilitation Approaches

NCT04142853 | Completed

• 1 other identifier: B707201835771
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (25)

• 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

• TST (Triple Stimulation Technique)

  Technique in which nerves are stimulated to check guidance in the central nervous system

  day 3

• TMS (Transcranial Magnetic Stimulation)

  Technique in which nerves are stimulated to check guidance in the central nervous system

  Day 3

• 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

• 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

• 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

• the Digit Span

  Cognitive test where numbers must be recalled in a certain order to evaluate short term memory

  Baseline

• the Digit Span

  Cognitive test where numbers must be recalled in a certain order to evaluate short term memory

  Week 11

• the Stroop test

  Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.

  Baseline

• the Stroop test

  Cognitive test to evaluate attention and simultaneous processing of multiple stimuli.

  week 11

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Fatigability Index Hand

  Grip strength will be evaluated through a Jamar dynamometer.

  Baseline

• Fatigability Index Hand

  Grip strength will be evaluated through a Jamar dynamometer.

  week 11

• 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

• 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

• 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 Outcomes (20)

• Fatigue severity scale (FSS)

  baseline

• Fatigue severity scale (FSS)

  week 11

• Modified Fatigue Impact Scale (MFIS)

  baseline

• Modified Fatigue Impact Scale (MFIS)

  week 11

• Fatigue Scale of Motor and Cognitive Functions (FSMC)

  baseline

Study Arms (2)

Persons with MS, dance group

EXPERIMENTAL

Other: Training intervention + Dance intervention

Persons with MS, art group

ACTIVE COMPARATOR

Other: Training intervention + Dance intervention

Interventions

Training intervention + Dance intervention OTHER

Training intervention + Dance intervention

Persons with MS, art group; Persons with MS, dance group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 70 years.
• MS diagnosis according to McDonald Criteria.
• Capable of walking 6 minutes (independent or with unilateral support) without stopping.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hasselt University: lead
• University of Liege: collaborator

Study Sites (2)

Hasselt University

Hasselt, 3500, Belgium

Location

Centre Hospitalier Universitaire de Liège

Liège, 4000, Belgium

Location

Related Publications (1)

• Goetschalckx M, Van Geel F, Meesen R, Triccas LT, Geraerts M, Moumdjian L, Feys P. Interlimb Coordination Performance in Seated Position in Persons With Multiple Sclerosis: Reduced Amplitude Over 6 min and Higher Coordination Variability in Persons With Walking Fatigability. Front Hum Neurosci. 2021 Oct 20;15:765254. doi: 10.3389/fnhum.2021.765254. eCollection 2021.

  PMID: 34744669 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: March 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: June 1, 2020

Record last verified: 2020-05

Locations

BE (2)