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临床试验/NCT06195644
NCT06195644Unknown1 期

Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年9月3日最近更新:
适应症
干预措施

试验速览

阶段
1 期
入组人数
40
试验地点
1
主要终点
Upper Limb motor dexterity

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with ataxic RRMS type of both genders will be recruited. The last MS relapse occurred at least 3 months prior to the study.
  • •Patients' age will range from 20 to 45 years old.
  • •Ambulant Patients who meet the level less than or equal to 5 on EDSS will be recruited.
  • •Patients' score on Mini Mental State Examination should be >
  • •Mild or no spasticity (grade 1 or 1+) according to Modified Ashworth Scale.
  • •All patients must at least hold Primary stage certificate of education from one of the Egyptian educational authorities.
  • •All patients can independently sign consent form

排除标准

  • •Patients will be excluded if they have:
  • •Moderate to severe auditory or visual or cognitive impairment.
  • •Coexistence of other neurological diagnoses of Central or Peripheral Nervous system (e.g. cerebrovascular stroke, vestibulopathy or polyneuropathy).
  • •History of any problems that hinder conduction of aerobic training or magnetic stimulation (e.g. deep venous thrombosis, shunts and pacemakers).

研究组 & 干预措施

GVS group

Experimental

Galvanic Vestibular Stimulation in addition to the Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

干预措施: Galvanic vestibular stimulation (Device)

GVS group

Experimental

Galvanic Vestibular Stimulation in addition to the Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

干预措施: MovAlyzeR® software from Neuroscript (Device)

GVS group

Experimental

Galvanic Vestibular Stimulation in addition to the Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

干预措施: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer) (Device)

CPT group

Active Comparator

Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

干预措施: MovAlyzeR® software from Neuroscript (Device)

CPT group

Active Comparator

Conventional Physical Therapy program of moderate intensity aerobic training on cyclic ergometer for upper limb and task oriented training for hand dexterity.

干预措施: BODYFIT Mini Portable Pedal Home Exerciser (cyclic ergometer) (Device)

结局指标

主要结局

Upper Limb motor dexterity

时间窗: 15-20 minutes

Nine hole peg test 9 HPT

Cortical changes

时间窗: 15 minutes

central motor conduction time is the time taken for neural impulses to travel through the central nervous system on their way to the target muscles.

次要结局

  • Fatigue(15-20 minutes)
  • Advanced dexterity (Handwriting analysis) by MovAlyzeR® software(15-20 minutes)
  • Balance(15-20 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hassanin

Assistant lecturer

Cairo University

研究点 (1)

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