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临床试验/NCT06312306
NCT06312306招募中不适用

Effect of Transcranial Direct Current Stimulation Versus Pilates Based Core Stability Training on Balance and Gait in Stroke Patients

Cairo University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
The Biodex Balance System

研究概览

简要总结

The goal of this clinical trial is to compare the effects of transcranial direct current stimulation and pilates based core stability training on gait and balance in stroke patients. The main question[s] it aims to answer are:

  • is there an effect of transcranial direct current stimulation and pilates based core training on gait and balance
  • Is there a significant effect of tDCS over Pilates-based core training

Participants will be assigned to three groups:

  • Group 1: will receive 18 sessions(3 sessions/week 20 minutes each) of anodal tDCS in addition to conventional physical therapy exercises
  • Group 2: Will receive 18 Pilates exercise sessions over a period of 6 weeks (3 sessions / week) in addition to conventional physical therapy exercises.
  • Group 3: Will receive conventional physiotherapy program

Researchers will compare the transcranial direct current stimulation group with the pilates exercise group to see if one of them is superior to the other on balance and gait.

详细描述

The ultimate goal for rehabilitation is to enhance functional performance in various essential real life activities. There is a need for a more effective, cost-efficient treatments for balance and gait in stroke patients. Many studies have reported that Pilates exercise has positive effects in development of muscular strength, endurance, flexibility, and in prevention of falls in elderly population and in orthopedic rehabilitation. However, there are only a few studies available with Pilates as intervention in neurological conditions such as multiple sclerosis, Parkinson's disease and stroke. This study aims to evaluate the efficacy of Pilates exercise on balance, in post stroke survivors and thereby provide an evidence for further studies in neurological conditions. Transcranial direct current stimulation(tDCS) is a promising noninvasive neuromodulatory intervention that aims to maximize recovery of function after stroke. There are numerous arguments to suggest that tDCS may become interesting tools to promote gait and balance improvement in stroke patients. The ability of these techniques to modulate cortical excitability was demonstrated. However, very few study has examined the effect of stimulating the SMA with tDCS on balance and gait performance. Motor learning is crucial in human daily life, both throughout the lifespan as well as for the recovery from a variety of neurological diseases. The ability of both exercise such as pilates and non invasive neuromodulation such as tDCS to modulate cortical excitability and therefore enhance motor learning has been demonstrated. Therefore, the aim of this study is to compare the effect of a Pilates-based core training program and tDCS over the supplementary motor area on balance and gait in stroke patients

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
50 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with either hemorrhagic or ischemic stroke for the first time, with an onset of more than eight weeks
  • Their age should be 50-60 years old.
  • Patients of a minor (1-4) to moderate (5-15) national institutes of health stroke scale (NIHSS) score.
  • Sufficient cognitive ability to participate, as indicated by Mini-mental state examination score of 21 or higher.
  • ambulatory before stroke
  • ability to stand or walk with or without assistance
  • mild to moderate spasticity (MAS scale less than grade 3)
  • hemodynamically stable

排除标准

  • History of seizures.
  • Patients with Any medical metal devices incompatible with transcranial direct current stimulation (e.g. pacemaker).
  • Bi-hemispheric or multifocal stroke.
  • any other neurological pathology affecting balance (cerebellar or brain stem lesions, impaired vision, visual field defect or hemineglect)
  • Premorbid neurological impairment prior to onset of stroke.
  • Co-morbidities impairing the motor function such as fracture or deformity.
  • Medically unstable.
  • Mental and cognitive impairment.

研究组 & 干预措施

Transcranial direct current stimulation (tDCS) group

Experimental

Anodal tDCS applied using a DC stimulator

干预措施: transcranial direct current stimulation (Device)

Transcranial direct current stimulation (tDCS) group

Experimental

Anodal tDCS applied using a DC stimulator

干预措施: conventional physiotherapy program (Other)

pilates based core training group

Experimental

The Pilates training program will last 30 min per session. The selected exercises will be given to all patients and progressed week-wise

干预措施: Pilates based core training (Other)

pilates based core training group

Experimental

The Pilates training program will last 30 min per session. The selected exercises will be given to all patients and progressed week-wise

干预措施: conventional physiotherapy program (Other)

control group

Active Comparator

Will receive conventional physiotherapy program

干预措施: conventional physiotherapy program (Other)

结局指标

主要结局

The Biodex Balance System

时间窗: 6 weeks

The Biodex Balance System (BBS; Biodex Inc.) will be used to assess postural stability. The BBS measures, in degrees, the tilt about each axis during dynamic conditions and calculates a medial-lateral stability index, anterior-posterior stability index, and an overall stability index.

Gait kinematics

时间窗: 6 weeks

Gait video will be recorded by a high-definition digital camera, and analysis will be done by Kinovea 2D motion analysis software

次要结局

  • Stroke Impact Scale (SIS)(6 weeks)

研究者

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

Aisha Mohamed Khaled Ahmed Saleh

M.Sc. in Physical Therapy

Cairo University

研究点 (2)

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