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

CompletedNot a drug-phase studyRelapsing MSNCT05367947

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • In-phase Bilateral Exercises of the upper limbs

What it measured

Main measures

  • Corticospinal Plasticity

    Through study completion, an average 35 weeks

    Myelin repairNerve conduction testsSafety

Other measures (6)

  • Mini Balance Evaluation Systems Test

    Through study completion, an average 35 weeks

    Walking and mobility
  • Six Spot Step Test

    Through study completion, an average 35 weeks

    VisionThinking and memoryWalking and mobilityPhysical functionSpasticity
  • Action Research Arm Test

    Through study completion, an average 35 weeks

    Arm and hand function
  • Isometric Dynamometer

    Through study completion, an average 35 weeks

    Physical function
  • Symbol Digit Modalities Test

    Through study completion, an average 35 weeks

    Thinking and memory
  • Modified Fatigue Impact Scale

    Through study completion, an average 35 weeks

    Fatigue

Who could take part

Relapsing MS · 30 to 70

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Mar 2023

    2. Main results due

      Oct 2023

    3. Finished

      Oct 2023

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