Status unknownPhase 1Relapsing MSNCT06195644

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Galvanic vestibular stimulation
  • MovAlyzeR® software from Neuroscript
  • BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer)

What it measured

Main measures

  • Cortical changes

    15 minutes

  • Upper Limb motor dexterity

    15-20 minutes

    Arm and hand function

Other measures (3)

  • Advanced dexterity (Handwriting analysis) by MovAlyzeR® software

    15-20 minutes

    Arm and hand function
  • Balance

    15-20 minutes

    Walking and mobility
  • Fatigue

    15-20 minutes

    Fatigue

Who could take part

Relapsing MS · 20 to 45

Inclusion Criteria: 1. Patients with ataxic RRMS type of both genders will be recruited. The last MS relapse occurred at least 3 months prior to the study. 2. Patients' age will range from 20 to 45 years old. 3. Ambulant Patients who meet the level less than or equal to 5 on EDSS will be recruited. 4. Patients' score on Mini Mental State Examination should be > 26. 5. Mild or no spasticity (grade 1 or 1+) according to Modified Ashworth Scale. 6. All patients must at least hold Primary stage certificate of education from one of the Egyptian educational authorities. 7. All patients can independently sign consent form Exclusion Criteria: * Patients will be excluded if they have: 1. Moderate to severe auditory or visual or cognitive impairment. 2. Coexistence of other neurological diagnoses of Central or Peripheral Nervous system (e.g. cerebrovascular stroke, vestibulopathy or polyneuropathy). 3. History of any problems that hinder conduction of aerobic training or magnetic stimulation (e.g. deep venous thrombosis, shunts and pacemakers).

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

About this trial

In the sponsor's words

This study will be conducted to investigate the following: 1. The impact of implementing GVS in MS rehabilitation on cortical excitability. 2. The influence of GVS on upper limb function in patients diagnosed with MS. Patients will be randomly assigned to a control group (Conventional Physical Therapy program = CPT) and a study group (Galvanic Vestibular Stimulation = GVS in addition to the conventional program) subsequently. CPT will perform moderate intensity aerobic training (arm ergometer) and task oriented hand manipulation training, while GVS will receive Galvanic Vestibular Stimulation will be added to the conventional physical Therapy program.

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History

    1. Started

      Sept 2023

    2. Main results due

      Dec 2024

    3. Finished

      Dec 2025

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