跳至主要内容
临床试验/CTRI/2023/08/056763
CTRI/2023/08/056763招募中3 期

Effect of low impact exercises with behavioral relaxation therapy on tremors, upper limb function and disability in patients with Parkinson’s Disease

Nagarjuna Narayanasetti1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月28日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Fahn’s Tremor Rating Scale (by blinding of outcome assessor) &

研究概览

简要总结

Background: The Parkinson’s Disease (PD) is a “complex neurodegenerative disorder, a second most common neurodegenerative disorder next to Alzheimer’s disease caused by deficiency of a neurochemichal ‘Dopamine’ in the nigrostriatum systemâ€. Tremor is a major motor cardinal symptoms in parkinson’s. The current pharmacological treatments carbidopa and levodopa combination, Anticholinergics and surgical interventions deep brain stimulation, Stereotactic thalamotomy are choice of treatment in severe cases and less published evidence on tremors. Clinical findings suggests that tremor increased by stress and usually physiotherapist suggests patients to practice meditation, yoga, breathing exercises and other relaxation techniques to reduce tremor. Objectives: The study will investigate effect of low impact exercises with behavioral relaxation therapy techniques on Parkinson’s tremor. Methodology : It will be a prospective experimental Randomized control study . 30 Hoehn and Yahr scale Stage III-IV Parkinson’s, and tremor dominating patients were randomly allocated into experimental and control group. Pre and post tests will be taken using Fahn’s Tremor rating scale (FTRS) , Bain and Findley Tremor ADL Scale ,9 hole peg test. Interventional Group will receive low impact exercises with Behavioral Relaxation Therapy (BRT) Techniques and Control group will receive conventional physiotherapy protocol and relaxation exercise thrice a week for 5 weeks under supervision of Physiotherapist and follow up after 6 weeks.

Keywords : Low impact exercises ,Behavioral Relaxation Therapy, Tremor, Upper limb function, Disability, Parkinson’s Disease.

研究设计

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

入排标准

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

入选标准

  • Diagnosed as Primary Parkinson’s Disease by Neurologist and fulfilled UK Parkinson’s Disease Society Brain Bank clinical Diagnostic Criteria (Hughes et al., 1992) Hoehn and Yahr scale Stage III-IV of Parkinson’s with Tremors dominating •UPDRS III Motor task 21 (Action or Postural tremor of hand) score of 2 or 3 (Mild to moderate Medically stable and taking prescribed medication Agrees to participate in the study.

排除标准

  • Secondary Parkinson’s syndrome, Parkinson’s Plus syndrome patients With other severe co-morbidities like lung, heart, kidney , liver, dysfunction, or cancer.
  • Patients with serious mental illness or dementia.
  • Patients with cognitive impairments.
  • PD patients without tremors.

结局指标

主要结局

Fahn’s Tremor Rating Scale (by blinding of outcome assessor) &

时间窗: 6 Weeks

Bain & Findley Tremor ADL Scale

时间窗: 6 Weeks

Behavioral Relaxation Scale (BRS)

时间窗: 6 Weeks

9 Hole peg test

时间窗: 6 Weeks

Unified Parkinson’s Disease Rating Scale (UPDRS), Part I – intellectual impairment, Part II – activities of daily living, Part III – motor examination

时间窗: 6 Weeks

次要结局

  • Behavioral Relaxation Scale(After every session)

研究者

发起方
Nagarjuna Narayanasetti
申办方类型
Other [self]

研究点 (1)

Loading locations...

相似试验