跳至主要内容
临床试验/CTRI/2023/03/051064
CTRI/2023/03/051064尚未招募不适用

Impact of dance/music and meditation on progression of Parkinson’s disease (PD) with mild and moderate severity. (PILOTSTUDY)

Jaslok Hospital and Research Centre1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2023年3月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
32
试验地点
1
主要终点
The Unified Parkinson’s Disease Rating Scale (MDS-UPDRS I-III)

研究概览

简要总结

Background:Parkinson’s disease (PD) is a multi-factorial disease that affects variousaspects, including motor and non-motor behaviours such as mood, cognition,behaviour and quality of life. There is some evidence suggesting that therapiessuch as music, dance and meditation help in reducing the progression ofParkinson’s disease. However, previous studies have focused more on the motoraspects of the disease than on the non-motor aspects.  There have been no studies, comprehensivelyinvestigating the benefit of dance/music and meditation on the quality of lifeof PD patients or the caretakers. There is also paucity in literature to assessthe effect of dance/music and meditation in an Indian setup.

Aims: The primary aim is to study theimpact of dance/music and meditation on mild and moderate Parkinson’s diseaseprogression and quality of life. The secondary aims of the project includedetecting the impact of the therapy on cognition, mood and behaviour. Theimpact on the quality of life of the caretaker will also be assessed.

 Methodology: This isa prospective randomized controlled pilot study with 32 patients with Parkinson’sdisease of mild and moderate severity, of which 16 are randomized intointervention and reference group each. The patients will be enrolled to takepart in three weekly sessions of dance/music and meditation for 6 months. Offthis, one session will take place in person weekly. The patients will choose amodality from dance and music, while all the patients will take part in 15minutes sessions of mindfulness meditation for 6 days every week. Within danceand music, the patients will be given options to choose an activity of theirinterest. In dance, the patients will be given the option of choosing fromBhangra, Bollywood and Garba. In music, the patients will be given the optionof auditory stimulation, singing and playing a musical instrument.

Expectedresults: It is expected that the patients will show a change in motoraspects such as change in gait and balance. It is also expected that there willbe an impact on the quality of life, mood, cognition and behaviour of thepatients. A change in quality of life of care-givers is also expected.

Evaluation: Thisstudy will be different to the prior studies that have been conducted as noneof the prior studies took into consideration the effect of all the threemodalities on quality of life, mood, cognition and behaviour. Furthermore, itis one of the few studies giving a choice to the patients in the form of themodality they will perform. This will ensure that the participants enjoy thestudy. However, the study might be subject to some limitations such as motorand non-motor disabilities as a result of Parkinson’s disease which mighthinder the participant from performing in the activities. Additionally, theresults might be confounded by factors such as medication taken by the patient.

Implicationsand Significance: So far there has not been any medical orsurgical management strategy for Parkinson’s disease, that has shownneuroprotective effect. Some of the similar studies have shown that thesetherapies may have neuroprotective effect. If this study also confirms the sameand shows the impact on QOL of patient and caretaker, it will have far reachingimplication in the way we manage Parkinson’s disease.

研究设计

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

入排标准

年龄范围
21.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Inclusive criteria:
  • Patients with young-onset and adult-onset PD can be included in the study.
  • Only mild and moderate PD patients, diagnosed with MDS criteria 2015 will be taken.
  • Patients giving consent for the study.

排除标准

  • Juvenile Parkinson’s disease and advanced Parkinson’s disease.
  • Patients who have underwent deep brain stimulation for PD.
  • Participants with extreme motor fluctuations and/or extreme speech disturbances
  • Patients who’s Parkinson Disease diagnosis not confirmed.
  • Patients not willing to participate in the study.

结局指标

主要结局

The Unified Parkinson’s Disease Rating Scale (MDS-UPDRS I-III)

时间窗: 0, 3 and 6 months

The Parkinson’s Disease Questionnaire (PDQ-39)

时间窗: 0, 3 and 6 months

次要结局

  • Parkinson’s anxiety scale, Becks Depression Inventory(Zerit Caregiver Burden Scale:)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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