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临床试验/CTRI/2024/04/065385
CTRI/2024/04/065385尚未招募1 期

Optimization and Efficacy of Exercise Protocols in patients suffering from Parkinson’s disease

Sakshi Jangra1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月20日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
1. Fullerton Advanced Balance Scale (FAB)

研究概览

简要总结

The aim of this study is to optimize and find efficacy of the exercise protocols on various parameters (balance, gait, respiratory function and psychological parameters) based on two factors that is frequency and repetitions in patients with Parkinson’s disease. Patients with Parkinson’s disease will be selected from various hospitals of Hisar. Patients will be screened on the basis of selection criteria. Whole experimental procedure will be explained and informed consent will be obtained from participants prior to commencement of the study. Participants will be randomly assigned into 9 groups.  Pre, Post and Follow up data will be obtained from the participants.  The duration of the intervention will be 6 weeks.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
40.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients of Idiopathic Parkinson Disease diagnosed with United Kingdom Parkinson’s Disease Society Brain Bank Clinical Diagnostic Criteria
  • Hoehn & Yahr stage 1-3
  • Lack of dementia.

排除标准

  • Presence of cardiovascular, pulmonary, orthopaedic or other medical conditions that limit the data collection.
  • Severe cognitive impairment.
  • Major psychological illness.
  • Prostheses in the lower limbs.

结局指标

主要结局

1. Fullerton Advanced Balance Scale (FAB)

时间窗: Baseline | 6 weeks | Follow up

2. Stride Length

时间窗: Baseline | 6 weeks | Follow up

3. Step Length

时间窗: Baseline | 6 weeks | Follow up

4. Cadence

时间窗: Baseline | 6 weeks | Follow up

5. New Freezing of Gait Questionnaire (NFOG-Q)

时间窗: Baseline | 6 weeks | Follow up

6. Parkinson Anxiety Scale (PAS)

时间窗: Baseline | 6 weeks | Follow up

次要结局

  • Forced Vital Capacity (FVC)(Baseline)
  • Forced Expiratory Volume in 1 second (FEV1)(Baseline)
  • Peak Expiratory flow (PEF)(Baseline)
  • FEV1/FVC (%)(Baseline)
  • Hamilton depression rating scale (HAM-D)(Baseline)

研究者

发起方
Sakshi Jangra
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sakshi Jangra

Guru Jambheshwar University of Science and Technology, Hisar Haryana 125001 India

研究点 (1)

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