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CTRI Number  CTRI/2023/03/051064 [Registered on: 27/03/2023] Trial Registered Prospectively
Last Modified On: 24/03/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Dance, Music and Meditation]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Dance, Music and Meditation therapy to slow progress of Parkinsons disease 
Scientific Title of Study   Impact of dance/music and meditation on progression of Parkinson’s disease (PD) with mild and moderate severity. (PILOT STUDY) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Paresh Doshi 
Designation  Director of Neurosurgery 
Affiliation  Jaslok Hospital & Research Centre 
Address  Department of Neurosurgery 11th floor Jaslok Hospital & Research Centre 15 Dr.G.Deshmukh Marg Gowalia Tank Cumballa Hill Mumbai
Department of Neurosurgery 11th floor Jaslok Hospital & Research Centre 15 Dr.G.Deshmukh Marg Gowalia Tank Cumballa Hill Mumbai
Mumbai
MAHARASHTRA
400026
India 
Phone  9820063854  
Fax    
Email  pareshkd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Paresh Doshi 
Designation  Director of Neurosurgery 
Affiliation  Jaslok Hospital & Research Centre 
Address  Deapartment of Neurosurgery 11th Floor Jaslok Hospital & Research Centre 15 Dr.G.Deshmukh Marg Gowalia Tank Cumballa Hill Mumbai
Deapartment of Neurosurgery 11th Floor Jaslok Hospital & Research Centre 15 Dr.G.Deshmukh Marg Gowalia Tank Cumballa Hill Mumbai
Mumbai
MAHARASHTRA
400026
India 
Phone  9820063854  
Fax    
Email  pareshkd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Paresh Doshi 
Designation  Director of Neurosurgery 
Affiliation  Jaslok Hospital & Research Centre 
Address  Department of Neurosurgery 11th Floor Jaslok Hospital & Research Centre 15 Dr.G.Deshmukh Marg Gowalia Tank Cumballa Hill Mumbai
Department of Neurosurgery 11th Floor Jaslok Hospital & Research Centre 15 Dr.G.Deshmukh Marg Gowalia Tank Cumballa Hill Mumbai
Mumbai
MAHARASHTRA
400026
India 
Phone  9820063854  
Fax    
Email  pareshkd@gmail.com  
 
Source of Monetary or Material Support  
Jaslok Hospital and Research Centre 
 
Primary Sponsor  
Name  Jaslok Hospital and Research Centre 
Address  15, Dr. G. Deskhmukh Marg, Mumbai - 400026 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Paresh Doshi  Jaslok Hospital and Research Centre  Dept of Neurosurgery 11th floor 15 Dr. deshmukh Marg, Mumabi 400026
Mumbai
MAHARASHTRA 
9820063854

pareshkd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Jaslok Hospital and Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G00-G99||Diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control group  No intervention- control group 
Intervention  Dance/ Music therapy with meditation  Methodology: This is a prospective randomized controlled pilot study with 32 patients with Parkinson’s disease of mild and moderate severity, of which 16 are randomized into intervention and reference group each. The patients will be enrolled to take part in three weekly sessions of dance/music and meditation for 6 months. Off this, one session will take place in person weekly. The patients will choose a modality from dance and music, while all the patients will take part in 15 minutes sessions of mindfulness meditation for 6 days every week. Within dance and music, the patients will be given options to choose an activity of their interest. In dance, the patients will be given the option of choosing from Bhangra, Bollywood and Garba. In music, the patients will be given the option of auditory stimulation, singing and playing a musical instrument 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Inclusive criteria:
1. Patients with young-onset and adult-onset PD can be included in the study.
2. Only mild and moderate PD patients, diagnosed with MDS criteria 2015 will be taken.
3. Patients giving consent for the study. 
 
ExclusionCriteria 
Details  1. Juvenile Parkinson’s disease and advanced Parkinson’s disease.
2. Patients who have underwent deep brain stimulation for PD.
3. Participants with extreme motor fluctuations and/or extreme speech disturbances
4. Patients who’s Parkinson Disease diagnosis not confirmed.
5. Patients not willing to participate in the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The Unified Parkinson’s Disease Rating Scale (MDS-UPDRS I-III)
The Parkinson’s Disease Questionnaire (PDQ-39) 
0, 3 and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Parkinson’s anxiety scale, Becks Depression Inventory
Zerit Caregiver Burden Scale:
PDQ Carer scale
Mini-Mental State Examination:
Berg Balance Scale (BBS)
Timed Up and Go test (TUG)
Questionnaire for Impulsive-Compulsive Disorders in Parkinson’s Disease- Rating Scale (QUIP-RS) 
0, 3 and 6 months 
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   27/03/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

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

 

Methodology: This is a prospective randomized controlled pilot study with 32 patients with Parkinson’s disease of mild and moderate severity, of which 16 are randomized into intervention and reference group each. The patients will be enrolled to take part in three weekly sessions of dance/music and meditation for 6 months. Off this, one session will take place in person weekly. The patients will choose a modality from dance and music, while all the patients will take part in 15 minutes sessions of mindfulness meditation for 6 days every week. Within dance and music, the patients will be given options to choose an activity of their interest. In dance, the patients will be given the option of choosing from Bhangra, Bollywood and Garba. In music, the patients will be given the option of auditory stimulation, singing and playing a musical instrument. 

Expected results: It is expected that the patients will show a change in motor aspects such as change in gait and balance. It is also expected that there will be an impact on the quality of life, mood, cognition and behaviour of the patients. A change in quality of life of care-givers is also expected.

Evaluation: This study will be different to the prior studies that have been conducted as none of the prior studies took into consideration the effect of all the three modalities on quality of life, mood, cognition and behaviour. Furthermore, it is one of the few studies giving a choice to the patients in the form of the modality they will perform. This will ensure that the participants enjoy the study. However, the study might be subject to some limitations such as motor and non-motor disabilities as a result of Parkinson’s disease which might hinder the participant from performing in the activities. Additionally, the results might be confounded by factors such as medication taken by the patient. 

Implications and Significance: So far there has not been any medical or surgical management strategy for Parkinson’s disease, that has shown neuroprotective effect. Some of the similar studies have shown that these therapies may have neuroprotective effect. If this study also confirms the same and shows the impact on QOL of patient and caretaker, it will have far reaching implication in the way we manage Parkinson’s disease.


 
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