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
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Behavioral: In-phase Bilateral Exercises of the upper limbs||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|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)|
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|
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.
- 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.
- 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.
- 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
- 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).
- 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.
- 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.
- 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
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
|Contact: Dimitris Sokratous, MS||00357 firstname.lastname@example.org|
|Study Director:||Dimitris Sokratous, MS||Cyprus University of Technology|