跳至主要内容
临床试验/CTRI/2020/01/022998
CTRI/2020/01/022998招募中1 期

A Study on Efficacy of Multichannel Transcranial Direct Current Stimulation on Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors

Punjabi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年1月31日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
60
试验地点
1
主要终点
Fugl Meyer Assessment

研究概览

简要总结

Need of the study

There has been a long standing view that motor recovery remains incomplete and many post stroke survivors live with disability throughout their life. Despite extensive exercise training and efforts, most of the neurorehabilitation (exercise training and task based intervention) models induce motor learning by “symptoms- based†approach in which these therapeutic approaches devote maximum emphasis on the motor learning with minimum focus on the cognitive domains.  As evidenced in the literature, Cognitive impairments may coexist with motor impairments and cognitive deficits may significantly alter the motor performance of affected individuals affecting their functional recovery.

Secondly, Reacquisition of motor functions also depends on interhemispheric motor circuits in the cerebral hemispheres. Motor recovery after stroke is related to neural plasticity, which refers to the ability of the brain to develop new neuronal interconnections, acquire new functions, and compensate for the impairment. The challenge for obtaining good recovery is to optimally utilize the broad spectrum intrinsic capacity of the brain in modulating viable neuronal networks and to provide intervention strategies for complete compensation of the loss due to injury to the brain. But Despite the implementation of novel therapeutic approaches, sometimes the effect size of single intervention is not sufficient enough to induce complete recovery; hence affected individuals live with the residual disabilities for the rest of their life.

Thirdly, Electrical interventions in the form of  (tDCS) has been found to be a promising tool for adding therapeutic benefits in post stroke rehabilitation with  its qualities of ease in application, safety and cost effectiveness and no adverse effects to the individuals. In Most of trials, the (tDCS) has been successively applied to the different cortical areas targeting the motor and cognitive deficits in isolation and at different point of time to yield the potential outcomes but, on the other side very little is known about the multi-target stimulation  of the cortical areas through (tDCS). There is huge scarcity of literature regarding clinical application of Multichannel transcranial direct current stimulation in subacute stroke survivors targeting the cognitive and motor functions simultaneously. Hence, there is a strong need to overcome the existing limitations in our current post stroke rehabilitation interventions and to utilize the integrated approach by targeting multiple areas taking into account the functional connectivity of cortical networks in respective functions.  Hence the present study aims to find out the efficacy of multi channel (tDCS) on cognitive domains, motor functions of paretic hand and gait in subacute stroke survivors.

Aim of the Study

To determine the efficacy of Multi Channel (tDCS) on Cognitive Domains, Motor Functions of Paretic Hand and Gait in Subacute Stroke Survivors.

Objectives of the Study

To determine the  Effect of Multi Channel (tDCS) in combination with Functional electrical stimulation (FES), Saebo FlexTM and conventional rehabilitation on Cognitive Domains, Motor Functions of Paretic Hand and Gait in individuals with subacute Stroke.

  1. On motor impairment of hemiplegic side, measured through Fugl Meyer Upper extremity Scale.
  2. On motor Functions of paretic hand i.e Grip strength and pinch strength, measured through Hand Dynamometer and Pinch Gauge respectively .
  3. On dexterity functions of paretic hand, measured through Nine Peg hole test (NPHT).
  4. On Cortical changes measured via EEG (Electroencephalogram).
  5. On Cognitive domains, measured through Montreal cognitive assessment scale.
  6. On locomotor function, measured through Wisconsin Gait scale.
  7. On quality of life following stroke, measured through Stroke specific quality of life scale

To determine the adverse effects of (tDCS) using (tDCS) adverse effect questionnaire

METHODOLOGY

The present study will be a prospective randomized controlled clinical trial.  Participants will be selected based on the sample selection criteria and will be randomly allocated into two independent   groups i.e Experimental Group (Group A) and Control Group (Group B) .

Ethical approval for the present study has been taken from the Institutional Ethical Committee, Punjabi University, Patiala.

Written consent will be taken from all the participants, willing to participate,  prior to the commencement of the study.

Subacute Stroke Survivors with the age Group (50-80 years) will constitute the Population of the study. The participants will be selected from Various Physiotherapy/rehabilitation Centres /Hospitals in and around Punjab. .

G Power software was used for sample size calculation.

The final sample size calculated to be 60, with (n=30) in each group

Baseline Assessment will be done for outcome measures of the study EEG, NHPT,

Grip Strength, Pinch strength, WGS, FMA, MOCA &  SS-QOL

Random allocation of Participants

Group A(Experimental Group- Multi channel tDCS) +FES+Saebo Flex+ Conventional Rehabilitation for 5 sessions/week for 4 weeks

Group B (Control Group) - sham Multi channel tDCS) +FES+Saebo Flex+ Conventional Rehabilitation for 5 sessions/week for 4 weeks

Post Intervention assessment will be done Day 15 and Day 30 for outcome measures of the study: EEG, NHPT, Grip Strength, Pinch strength, WGS, FMA, MOCA & SS-QOL

Data will be collected

Statistical analysis will be done

研究设计

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

入排标准

年龄范围
40.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • 1.Subacute stroke survivors.
  • 2.Males and females 3.Individuals of the age group (40- Years).
  • 4.Modified Ashworth Scale Score < 2 5.Preserved Range of Wrist Extension (≈10 Degrees).
  • 6.Individuals who are able to walk
  • Individuals with mild cognitive Impairment Mini Mental State Examination (MMSE) Score (18-23).
  • 8.Individuals, who are willing to participate in the study.

排除标准

  • 1.Individuals diagnosed with hemorrhagic stroke 2.Individuals with a history of neurological disease other than stroke.
  • 3.Individuals with a history of musculoskeletal injury/disease affecting upper Extremity and lower extremity.
  • 4.Individuals with Psychosomatic Illness/ Disease.
  • 5.Individuals with severe cardiovascular & respiratory problem 6.Individuals with uncontrolled hypertension 7.Individuals with any systemic illness.
  • 8.Pregnant women 9.Individuals with metallic Implants.
  • 10.Visual analog scale for pain score >4 in the upper Extremity/lower extremity.
  • 11.Participation in other pharmacological & rehabilitation studies during the study period.
  • 12.Individuals with hypersensitivity or hypoensitivity disorders.
  • 13.Non Cooperative Individuals.

结局指标

主要结局

Fugl Meyer Assessment

时间窗: 04 Weeks

Electroencephalography

时间窗: 04 Weeks

次要结局

  • Montreal Cognitive Assessment(Nine Hole Peg Test)

研究者

申办方类型
Research institution

研究点 (1)

Loading locations...

相似试验