CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 5 enrolled
Drug / intervention
In-phase Bilateral Exercises of the upper limbsbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05367947
NCT05367947N/ACompleted

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

Cyprus University of Technology·interventional·Posted May 10, 2022·Updated Feb 7, 2024

In Brief

A clinical study evaluating In-phase Bilateral Exercises of the upper limbs for Multiple Sclerosis. Completed, enrolled 5 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCyprus

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 10, 2022
Enrollment StartMar 10, 2023
Primary CompletionOct 6, 2023
Study CompletionOct 13, 2023
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.1 years ago

Interventions

In-phase Bilateral Exercises of the upper limbsbehavioral

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.