跳至主要内容
临床试验/CTRI/2022/05/042526
CTRI/2022/05/042526尚未招募不适用

Efficacy of Transcranial Direct Current Stimulation and Sensorimotor Training on Balance and Gait in Stroke Patients: A Randomized Controlled Trial

Guru Jambheshwar University of Science and Technology Hisar1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2022年5月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
75
试验地点
1
主要终点
Berg Balance Scale

研究概览

简要总结

Stroke is the second major cause of death and the third most frequent cause of impairments worldwide. The global burden of stroke is approximated to be more than 80 million stroke patients reported in 2016.  The number of stroke cases is increasing in India, due to demographic transition. The prevalence rate of stroke ranges from 84–262/100,000 in rural and 334–424/100,000 in cities of India. Based on recent data approximately 119-145/100,000 cases of stroke are noted. It leads to motor and sensory impairment including muscle weakness, spasticity, incoordination, proprioception which leads to residual deficits, imbalance and gait abnormalities.Noninvasive neuromodulatory techniques are hypothesised to change synaptic effectiveness in glutamatergic and GABAergic circuits, which are important for motor learning. Among the NIBS techniques, Transcranial direct current stimulation is extensively used alone or in combination with other therapies in past decade to improve motor functions, balance and gait in stroke patients and has shown significant results in improving post stroke residual impairments. tDCS has been proved to be promising approach in treating imbalance and gait abnormalities. Sensorimotor training (SMT) is thought to influence the control of equilibrium and posture by active & passive facilitation of afferents.SMT affects the higher centers of subcortical structures through spinothalamic, vestibulospinal, and vestibulocerebellar pathways that influence the coordinated posture and equilibrium. So, the combination of the tDCS with sensorimotor training may prove to be beneficial in improving balance and gait in stroke patients. But so far, the combined effect of tDCS and sensorimotor training has not been investigated. Therefore, the main aim of this study is to evaluate the effect of tDCS with sensorimotor training on the balance and gait in stroke patients.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients with chronic stroke (>6 months, both ischaemic & haemorrhagic) with FMA-LE more than
  • Patient able to walk independently or with assistance.
  • No Relapse between 3-6 months.
  • Normal or corrected vision.
  • No cerebellar lesion.

排除标准

  • Psychiatric disorders.
  • Patient with history of brain injury, cranial bone anomalies, cranial bone fractures and surgeries.
  • History of epileptic seizures.
  • Uncooperative patients.
  • Metal implant in the stimulation area.
  • Vestibular disorders.
  • Skin allergy.
  • Cognitive impairment.
  • Congenital/acquired deformity.

结局指标

主要结局

Berg Balance Scale

时间窗: Baseline | After 4 weeks | After 1 month

Time Up and Go Test

时间窗: Baseline | After 4 weeks | After 1 month

Dynamic gait Index

时间窗: Baseline | After 4 weeks | After 1 month

Electromyography(EMG)

时间窗: Baseline | After 4 weeks | After 1 month

次要结局

未报告次要终点

研究者

发起方
Guru Jambheshwar University of Science and Technology Hisar
申办方类型
Other [university]

研究点 (1)

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