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In-phase Bilateral Exercises in People With Relapsing Remitting Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05367947
Recruitment Status : Not yet recruiting
First Posted : May 10, 2022
Last Update Posted : May 10, 2022
Sponsor:
Collaborator:
The Cyprus Foundation for Muscular Dystrophy Research
Information provided by (Responsible Party):
Dimitris Sokratous, Cyprus University of Technology

Brief Summary:
Relapsing-remitting multiple sclerosis (RRMS) is associated with changes of the corticospinal tract integrity, which is quantified by means of corticospinal plasticity. Several factors, such as exercise and interlimb coordination can influence such corticospinal plasticity. Previous work in healthy and in stroke participants showed that the greatest improvement of corticospinal plasticity occurred during in-phase bilateral arm exercises. Here, the investigators propose a concurrent multiple baseline design study which has the advantage to verify the cause-effect inference by the staggered duration through separate baseline phases. The proposed study includes five people with RRMS, who will follow an intervention protocol which includes in-phase bilateral movements of the upper limbs, adapted to different sports activities and to functional training. The aim of the study is to investigate the effects of in-phase bilateral exercises on corticospinal plasticity and on clinical measures, using transcranial magnetic stimulation and standardized clinical assessment. To meet quality standards, the present study has been designed and will be conducted according to the "What Works Clearinghouse" criteria for single case studies.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: In-phase Bilateral Exercises of the upper limbs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: The study follows a concurrent multiple baseline design across subjects, which involves five people with RRMS that will be managed as five different case studies. The specific design has the advantage to verify the cause-effect inference clearly by the staggered duration through separate baseline phases
Masking: None (Open Label)
Masking Description:

Participants are people with multiple sclerosis according inclusion/exclusion criteria.

Investigators are health professionals (i.e., physiotherapist, sports scientist, neuropsychologist, neurologist, biostastician).

Primary Purpose: Basic Science
Official Title: Investigation of In-phase Bilateral Exercise Effects on Corticospinal Plasticity in Relapsing Remitting Multiple Sclerosis: a Multiple Baseline Design
Estimated Study Start Date : October 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: In-phase bilateral RRMS Participants A-E
The study follows a concurrent multiple baseline design across subjects, which involves five people with RRMS as five different case studies.
Behavioral: In-phase Bilateral Exercises of the upper limbs

The intervention protocol consists of in-phase bilateral exercises for the upper limbs, which are adapted to different sport activities and to fitness functional exercises, organized in a circuit training. Specifically, each session will consist of 1-3 sets, consisting of 10-15 repetitions of 9 different exercises targeting large muscle groups of the upper limbs.

The specific exercises will include sports activities of basic technical skills of basketball (e.g., different types of passing, catching and throwing the ball) and volleyball (e.g., different types of passing and receiving the ball), whereas the fitness exercises will include shoulder rows, shoulder lateral raises, elbow flexions, elbow extensions, using resistance elastic bands, as well as exercises with the patients' own body weight (e.g., pushups, TRX).

The intervention phase for each participant will consist of 12 consecutive weeks, for 3 times per week, 30-60 minutes each session.





Primary Outcome Measures :
  1. Corticospinal Plasticity [ Time Frame: Through study completion, an average 35 weeks ]
    The investigators will assess the corticospinal plasticity using single pulse Transcranial Magnetic Stimulation (TMS). Following TMS recommended guidelines concerning safety and experimental conditions, bilateral cortical excitability and bilateral central motor conduction time (CMCT) will be assessed. Using electromyography (EMG) signals, the investigators will analyze bilateral cortical excitability and bilateral CMCT to determine corticospinal plasticity. The resting motor threshold (rMT) and the Motor Evoked Potential (MEP) amplitude of Abductor Pollicis Brevis muscle will define cortical excitability, while the MEP latency will be used to calculate the CMCT. To ensure methodological consistency, the investigators will collect all data by performing the same methodological procedures for both conditions (i.e., cortical excitability and CMCT) bilaterally (one side per assessment), across participants and across all time points.


Secondary Outcome Measures :
  1. Mini Balance Evaluation Systems Test [ Time Frame: Through study completion, an average 35 weeks ]
    It measures dynamic balance, functional mobility, and gait in neurological patients, including people with multiple sclerosis. The specific test consists of 14 items, including four of the six segments (anticipatory postural adjustments, sensory orientation, reactive postural control and dynamic gait) from the Balance Evaluation Systems Test.

  2. Six Spot Step Test [ Time Frame: Through study completion, an average 35 weeks ]
    It is a timed walking test that involves kicking over a number of targets placed along a 5m-path in which rely to some extent on vision and cognition. The Six Spot Step Test is measured in the time domain replicating a complex range of sensorimotor functions, part of which are lower limb strength, spasticity, coordination, as well as balance

  3. Action Research Arm Test [ Time Frame: Through study completion, an average 35 weeks ]
    It is a 19-item observational measure used by physiotherapists and other health care professionals to examine upper limb performance (i.e., coordination, dexterity and functioning). Items covering the Action Research Arm Test are categorized into four subscales (grasp, grip, pinch and gross movement).

  4. Isometric Dynamometer [ Time Frame: Through study completion, an average 35 weeks ]
    We well assess the isometric muscle force of major muscle groups with the use of a hand held dynamometer, which is used in the evaluation and rehabilitation of muscle strength. Shoulder flexors, extensors, rotators, horizontal adductors and abductors adductors and abductors, elbow flexors and extensors are the major muscle groups which will be evaluated.

  5. Symbol Digit Modalities Test [ Time Frame: Through study completion, an average 35 weeks ]
    We will employ the oral form which assesses the information processing speed. During the test, the participant will be given two minutes to orally match symbols with digits as quickly as possible.

  6. Modified Fatigue Impact Scale [ Time Frame: Through study completion, an average 35 weeks ]
    It is a short questionnaire which requires the participants to describe the effects of fatigue during the past four weeks



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with relapsing remitting multiple sclerosis
  • Expanded Disability Status Scale score between three and five
  • Aged between 30 and 70 years
  • Relapse within 30 days
  • Mini Mental State of Examination score between 24 and 30 (no cognitive impairment)

Exclusion Criteria:

  • Metal implants
  • History of any disease affecting the central nervous system other than multiple sclerosis
  • History of cardiovascular disease
  • Mental disorders
  • Severe orthopedic disorders
  • Pregnancy
  • Visual deficit
  • Hearing impairments,
  • Εpileptic seizures
  • Spasticity level on upper or lower limbs more than 1+ (slight increase in muscle tone) according to Modified Ashworth Scale

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05367947


Contacts
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Contact: Dimitris Sokratous, MS 00357 99571991 sokratous.physio@gmail.com

Sponsors and Collaborators
Cyprus University of Technology
The Cyprus Foundation for Muscular Dystrophy Research
Investigators
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Study Director: Dimitris Sokratous, MS Cyprus University of Technology
Publications:
Kratochwill, T. R. Hitchcock, J. Horner, R. H. Levin, J. R. Odom, S. L. Rindskopf, D. M Shadish WR. Single-Case Design Technical Documentation. Work Clear website http//ies.ed.gov/ncee/wwc/pdf/wwc_scd.pdf. 2010;(December):2010.

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Responsible Party: Dimitris Sokratous, Mr, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT05367947    
Other Study ID Numbers: IBEMS
First Posted: May 10, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dimitris Sokratous, Cyprus University of Technology:
transcranial magnetic stimulation
multiple sclerosis
exercise
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases