| CTRI Number |
CTRI/2026/03/105424 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/09/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Occupational Therapy] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving movement and daily activities in Parkinson’s disease through functional task training with rhythmic cues |
|
Scientific Title of Study
|
Effectiveness of Functional Task Training with Rhythmic Auditory Stimulation to improve Motor Functions and Activities of Daily Living in Parkinson's Disease |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhana Sharon |
| Designation |
PG Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research (DU) |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy
Sri Ramchandra Institute of Higher Education and Research (Deemed to be university) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy
Sri Ramchandra Institute of Higher Education and Research (Deemed to be university) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU
600116
India |
| Phone |
7591961301 |
| Fax |
|
| Email |
sharondhana2255@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research ( SRIHER, DU) |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy
Sri Ramchandra Institute of Higher Education and Research (Deemed to be university) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy
Sri Ramchandra Institute of Higher Education and Research (Deemed to be university) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Loganathan S |
| Designation |
Assistant Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research ( SRIHER, DU) |
| Address |
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy
Sri Ramchandra Institute of Higher Education and Research (Deemed to be university) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
4th Floor Vidya Sudha Building Sri Ramachandra Faculty of Occupational Therapy
Sri Ramchandra Institute of Higher Education and Research (Deemed to be university) No 1 Ramachandra Nagar Porur Chennai Tamil Nadu 600116 India
Chennai
TAMIL NADU
600116
India |
| Phone |
9841958099 |
| Fax |
|
| Email |
loganathanot@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dhana sharon |
| Address |
Sri Ramachandra Medical College
Sri Ramachandra Nagar
Porur
Chennai
Tamil Nadu 600116 |
| Type of Sponsor |
Other [Other (self funding)] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| M Madhan Kumar |
Akshaya Trust - Velappanchavadi |
Ground Floor and Second Floor 5 Noombal Rd
Velappanchavadi
Kattupakkam
Chennai
Tamil Nadu 600077
Chennai
TAMIL NADU |
7010191233
velapanchavadi@akshayachennai.org |
| John Crysotom |
Johns Physio and Rehab Centre |
Ground Floor
Pillayar Koil Street
New Colony
Lakshmi Nagar
Porur
Tiruvallur
Chennai
Tamil Nadu 600116
Chennai
TAMIL NADU |
9123554159
johnphysiocentre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRIHER |
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 Occupational Therapy |
Participants in the control group will receive Conventional Occupational Therapy focusing on functional task-based training without rhythmic auditory cues. The therapy sessions will include task-oriented activities aimed at improving motor function and activities of daily living. The duration and frequency of sessions will be the same as that of the experimental group. |
| Intervention |
Functional Task Training with Rhythmic Auditory Stimulation |
Rhythmic Auditory Stimulation is provided as a supplement to Functional Task Training using the Soundbrenner app for the experimental group. The participants in the experimental group will perform functional task based activities synchronized with rhythmic auditory cues. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individuals diagnosed with Parkinson’s Disease, identified through secondary data collection
Individuals in Hoehn and Yahr Stages 1 to 3
Individuals aged between 50 and 75 years
Individuals who score less than 10 on the Six-Item Cognitive Impairment Test
Individuals who are able to understand and write in either English or Tamil
|
|
| ExclusionCriteria |
| Details |
Other neurological disorders that limit participation in the study
Unstable medical or psychiatric conditions, orthopedic conditions, hearing impairments |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Functional Task Training with Rhythmic Auditory Stimulation on motor functions and activities of daily living Parkinson’s disease, measured by the SCOPA–SPES (Scales for Outcomes in Parkinson’s Disease – Motor and Activities of Daily Living subscales). |
Baseline (Pre - intervention) and after 4 weeks of intervention (Post - intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2026 |
| Date of Study Completion (India) |
15/06/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/06/2026 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
This study aims to find out the effectiveness of Functional Task Training with Rhythmic Auditory Stimulation to improve motor functions and activities of daily living in Parkinson’s Disease. This study is of experimental study design with a total sample size of 30 in which the participants will be allocated to an experimental group and a control group by fixed blocked randomization. The experimental group receives the Functional Task Training with Rhythmic Auditory Stimulation, while the control group receives the Conventional Occupational Therapy. This study happens in a time period of 4 months, with each participant receiving 12 sessions of therapy 3 times a week for 4 weeks. |