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

NCT05367947 | Completed

• 1 other identifier: IBEMS
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

transcranial magnetic stimulation; multiple sclerosis; exercise

Outcome Measures

Primary Outcomes (1)

• Corticospinal Plasticity

  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.

  Through study completion, an average 35 weeks

Secondary Outcomes (6)

• Mini Balance Evaluation Systems Test

  Through study completion, an average 35 weeks

• Six Spot Step Test

  Through study completion, an average 35 weeks

• Action Research Arm Test

  Through study completion, an average 35 weeks

• Isometric Dynamometer

  Through study completion, an average 35 weeks

• Symbol Digit Modalities Test

  Through study completion, an average 35 weeks

Study Arms (1)

In-phase bilateral RRMS Participants A-E

EXPERIMENTAL

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

Interventions

In-phase Bilateral Exercises of the upper limbs BEHAVIORAL

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.

In-phase bilateral RRMS Participants A-E

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Cyprus University of Technology: lead
• The Cyprus Foundation for Muscular Dystrophy Research: collaborator

Study Sites (1)

Dimitris Sokratous

Limassol, Cyprus

Location

Related Publications (10)

• Neva JL, Lakhani B, Brown KE, Wadden KP, Mang CS, Ledwell NH, Borich MR, Vavasour IM, Laule C, Traboulsee AL, MacKay AL, Boyd LA. Multiple measures of corticospinal excitability are associated with clinical features of multiple sclerosis. Behav Brain Res. 2016 Jan 15;297:187-95. doi: 10.1016/j.bbr.2015.10.015. Epub 2015 Oct 20.

  PMID: 26467603 BACKGROUND

• Pascual-Leone A, Tarazona F, Keenan J, Tormos JM, Hamilton R, Catala MD. Transcranial magnetic stimulation and neuroplasticity. Neuropsychologia. 1999 Feb;37(2):207-17. doi: 10.1016/s0028-3932(98)00095-5.

  PMID: 10080378 BACKGROUND

• Whitall J, Waller SM, Sorkin JD, Forrester LW, Macko RF, Hanley DF, Goldberg AP, Luft A. Bilateral and unilateral arm training improve motor function through differing neuroplastic mechanisms: a single-blinded randomized controlled trial. Neurorehabil Neural Repair. 2011 Feb;25(2):118-29. doi: 10.1177/1545968310380685. Epub 2010 Oct 7.

  PMID: 20930212 BACKGROUND

• Smith AL, Staines WR. Cortical and behavioral adaptations in response to short-term inphase versus antiphase bimanual movement training. Exp Brain Res. 2010 Sep;205(4):465-77. doi: 10.1007/s00221-010-2381-5. Epub 2010 Aug 14.

  PMID: 20711566 BACKGROUND

• Neva JL, Legon W, Staines WR. Primary motor cortex excitability is modulated with bimanual training. Neurosci Lett. 2012 Apr 18;514(2):147-51. doi: 10.1016/j.neulet.2012.02.075. Epub 2012 Mar 3.

  PMID: 22405809 BACKGROUND

• 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.

  BACKGROUND

• Zhan S, Ottenbacher KJ. Single subject research designs for disability research. Disabil Rehabil. 2001 Jan 15;23(1):1-8. doi: 10.1080/09638280150211202.

  PMID: 11213316 BACKGROUND

• Lobo MA, Moeyaert M, Baraldi Cunha A, Babik I. Single-Case Design, Analysis, and Quality Assessment for Intervention Research. J Neurol Phys Ther. 2017 Jul;41(3):187-197. doi: 10.1097/NPT.0000000000000187.

  PMID: 28628553 BACKGROUND

• Sokratous D, Charalambous CC, Zamba-Papanicolaou E, Michailidou K, Konstantinou N. A 12-week in-phase bilateral upper limb exercise protocol promoted neuroplastic and clinical changes in people with relapsing remitting multiple sclerosis: A registered report randomized single-case concurrent multiple baseline study. PLoS One. 2024 Oct 17;19(10):e0299611. doi: 10.1371/journal.pone.0299611. eCollection 2024.

  PMID: 39418242 DERIVED

• Sokratous D, Charalambous CC, Papanicolaou EZ, Michailidou K, Konstantinou N. Investigation of in-phase bilateral exercise effects on corticospinal plasticity in relapsing remitting multiple sclerosis: A registered report single-case concurrent multiple baseline design across five subjects. PLoS One. 2023 Mar 2;18(3):e0272114. doi: 10.1371/journal.pone.0272114. eCollection 2023.

  PMID: 36862693 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Dimitris Sokratous, MS

  Cyprus University of Technology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are people with multiple sclerosis according inclusion/exclusion criteria. Investigators are health professionals (i.e., physiotherapist, sports scientist, neuropsychologist, neurologist, biostastician).
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mr

Model Details: 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

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 10, 2022
• Study Start: March 10, 2023
• Primary Completion: October 6, 2023
• Study Completion: October 13, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

CY (1)