| 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
|
|
|
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
|
|
|
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. |