| CTRI Number |
CTRI/2026/02/103020 [Registered on: 04/02/2026] Trial Registered Prospectively |
| Last Modified On: |
04/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
The role of mindfulness in improving balance and walking in parkinson disease |
|
Scientific Title of Study
|
Effect of mindfulness based stress reduction on motor symptoms in parkinson disease A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aryan Kargwal |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement , Department of Physiotherapy, Manipal Hospital,
No 98, Rustam Bagh, Old Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
8824565778 |
| Fax |
|
| Email |
aryan.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunima Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport
Road, Rustam Bagh, Old Airport Road,
Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9987194977 |
| Fax |
|
| Email |
arunima.biswas@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport
Road, Rustam Bagh, Old Airport Road,
Bangalore
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of
Higher Education, Manipal Hospital #98, HAL,Old Airport Road, Bangalore,
KARNATAKA 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL,Old Airport Road, Bangalore, KARNATAKA 560017 |
| 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 |
| Aryan Kargwal |
Manipal Hospitals |
Upper Basement ,
Department of
Physiotherapy, Manipal
Hospital, No 98,
Rustam Bagh, Old
Airport Road,
Bangalore,
KARNATAKA
Bangalore
KARNATAKA |
8824565778
aryan.mhsblr2024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
stretching, resistance training, balance,
coordination and gait training tailored according to patients |
| Intervention |
Mindfulness based stress reduction |
Mindfulness-based stress reduction will be given which will consist of the following techniques, Body Scan -Participants pay attention to parts of the body from toe to head, Mindful Yoga-Aims to arouse mindful awareness while observing the body, Sitting Meditation- Focus on the flow of breath while sitting (mindful breathing), Walking Meditation- Focus on bodily sensations of walking, Loving-Kindness Meditation- Pay attention to different objects and beings with kindness and compassion. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with idiopathic PD for 1 year, Disease severity stages I-III Hoehn and Yahr scale, Subjects with intact cognition MoCA score greater than 25, Patients on medication as well as those not on medication at the time of recruitment will be included. |
|
| ExclusionCriteria |
| Details |
Patients who are currently receiving treatment for mental disorders or with uncontrolled mood disorders, Incapability to perform intervention exercises due to concurrent medical
conditions |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unified Parkinson Disease Rating Scale Part III |
Pre post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 6 Minute walk test |
Pre post |
| 10 Meter walk test |
Pre post |
| Timed up and go test |
Pre post |
| Hospital Anxiety and Depression Scale |
Pre post |
| Parkinson’s Disease Questionnaire 39 |
Pre post |
| Five Facet Mindfulness Questionnaire |
Pre post |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
27/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In Parkinson’s disease, while therapeutic exercise remains a standard Intervention, integrating Mindfulness-Based Stress Reduction, a structured mind-body approach, may offer a holistic rehabilitation strategy by addressing both motor and psychological symptoms in Parkinson’s disease. The primary aim of this study is to find out the effectiveness of mindfulness-based stress reduction combined with therapeutic exercise on motor symptoms in individuals with PD. |