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临床试验/NCT04174573
NCT04174573Unknown不适用

Efficacy of Group Therapy With Transcranial Direct Current Stimulation on Balance and Quality of Life in Patients With Parkinson's Disease: A Single Blind, Multi-centre, Randomized Clinical Study

Maharishi Markendeswar University (Deemed to be University)0 个研究点目标入组 64 人开始时间: 2022年6月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
64
主要终点
Parkinson's Disease Questionnaire with 39 items

研究概览

简要总结

To determine the effectiveness of group therapy along with transcranial direct current (tDCS) stimulation on motor symptoms, balance and quality of life in patients with Parkinson's disease(PD). 128 patient with PD will be recruited by the cluster sampling method for the two group pretest-posttest randomized controlled trial. The patient with PD will be allocated in two groups, Group therapy only (GTO) group and Group therapy with tDCS (GT-tDCS) treatment group by block randomization technique. Both GTO group and GT-tDCS group will receive the structured group therapy programme for one hour duration, twice a week for 6-weeks. In addition to the structured group therapy programme, GT-tDCS group will receive 20 minutes of tDCS application once a week for the 6-week duration. Data will be analysed at baseline, 3 weeks and 6 weeks of post intervention.

详细描述

Introduction:

Parkinson disease (PD) occurs due to degenerative changes in the nervous system, dysfunctions of basal ganglia. Patients affected with PD survive with the postural and mobility impairments that leads to impaired quality of life. Medical and surgical procedures do not provide the patient with a fully effective response.1 Literature suggests that physical therapy can improve the quality of life and balance function in patients with PD. Group therapy (GT) intervention is found to be significant intervention in aspects of mobility in various neurological conditions. GT have been used as part of supervised group rehabilitation to improve balance in patient with PD.2 Patients with PD have difficulties with learning of new motor skills, but recent neuro-modulatory techniques by noninvasive brain stimulation helps to facilitate motor skills and regulate neuroplasticity.

Transcranial direct current stimulation (tDCS) is a therapeutic device that is used to improve motor symptoms of PD, when applied to primary motor cortex M1. Anodal tDCS can increase M1 excitability, reduce cortical inhibition and results in improved functional performance. When combined with other exercise training, it provides longer lasting effect in motor function.3 However, no studies have investigated the concurrent use of anodal tDCS and group therapy intervention in patient with PD.

The aims of this study are to determine the effects of a 3 weeks concurrent GT and anodal tDCS intervention on measures of static and dynamic balance and to evaluate any long-term effects.

The investigators hypothesize that the combination of group therapy and anodal tDCS will improve balance and quality of life than group therapy or anodal tDCS alone.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Presence of mild neurocognitive disorders was based on the validated Montreal Cognitive Assessment (MoCA) cutoff scores (<23.5)
  • •Based on the Hoehn-Yahr Stage (HYS) staging, severity of PD was categorized as mild (HYS 1&2), moderate (HYS 3) and severe (HYS 4&5). Patient with PD with mild and moderate will be recruited

排除标准

  • •Patient with PD with associated comorbidities such as stroke, uncontrolled diabetes, sensory impairments such as hearing, vision, etc.
  • •Patient with PD who is not willing to participate in the study

研究组 & 干预措施

Group therapy only (GTO)

Experimental

Patients in GTO group will receive structured group therapy programme

干预措施: GTO (Other)

Group therapy with tDCS (GT-tDCS)

Experimental

Patients in this group will receive group therapy along-with tDCS intervention

干预措施: GT-tDCS (Other)

结局指标

主要结局

Parkinson's Disease Questionnaire with 39 items

时间窗: Change will be measured at baseline, 3 weeks and after 6 weeks of intervention

The PDQ-39 is a 39-item self-report questionnaire, which assesses Parkinson's disease-specific health related quality over the last month. Assesses how often patients experience difficulties across the 8 quality of life dimensions. Assesses impact of Parkinson's Disease (PD) on specific dimensions of functioning and well-being. Each dimension total score ranges from 0 (never have difficulty) to 100 (always have difficulty). lower score reflect better quality of life.

Movement Disorders Society Sponsored Unified Parkinson's Disease Rating Scale (MDS-UPDRS).

时间窗: Change will be measured at baseline, 3 weeks and after 6 weeks of intervention

The Unified Parkinson Disease Rating Scale, designed to monitor the burden and extent of Parkinson's disease. o-4 score, lower the score indicates normal, higher the scores indicate greater impact of PD symptoms.

次要结局

未报告次要终点

研究者

发起方
Maharishi Markendeswar University (Deemed to be University)
申办方类型
Other
责任方
Principal Investigator
主要研究者

Asir John Samuel

Associate Professor

Maharishi Markendeswar University (Deemed to be University)

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