| CTRI Number |
CTRI/2025/04/084526 [Registered on: 09/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To find out the effect of Repetitive Transcranial Magnetic Stimulation and Task-specific Trunk Control training in person having Parkinsons Disease |
|
Scientific Title of Study
|
Combined Effect of Repetitive Transcranial Magnetic Stimulation and Task-Specific Trunk Control Training on Postural Stability in Individuals with 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 |
Akshita Jain |
| Designation |
Masters Student |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147002
India |
| Phone |
7087063123 |
| Fax |
|
| Email |
akshi.jain006@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narkeesh Arumugam |
| Designation |
Professor |
| Affiliation |
Punjabi University |
| Address |
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147002
India |
| Phone |
9417802662 |
| Fax |
|
| Email |
narkeesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narkeesh Arumugam |
| Designation |
Professor |
| Affiliation |
Punjabi University |
| Address |
Department of Physiotherapy, Punjabi University, Patiala
Patiala
PUNJAB
147002
India |
| Phone |
9417802662 |
| Fax |
|
| Email |
narkeesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Narkeesh Arumugam
Department of Physiotherapy, Punjabi University, Patiala, Punjab, India, 147002 |
|
|
Primary Sponsor
|
| Name |
Dr Narkeesh Arumugam |
| Address |
Department of Physiotherapy, Punjabi University, Patiala-147002 |
| Type of Sponsor |
Other [Supervisor] |
|
|
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 |
| Dr Narkeesh Arumugan |
Punjabi University |
Department of Physiotherapy, Punjabi University, near Urban Estate Phase 2, Patiala, Punjab, 147002
Patiala
PUNJAB |
9417802662
narkeesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
Control Group |
The control group will get sham rTMS with task-specific trunk control training + conventional physiotherapy for 15 days (5 days per week for 3 weeks) |
| Intervention |
Experimental Group |
The Experimental Group will get rTMS with task-specific trunk control training + conventional physiotherapy for 15 day (5 days per week for 3 weeks) |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who will be willing to participate and able to give informed consent.
Individuals diagnosed with Parkinson’s disease according to ICF domains.
Individuals with Hoehn & Yahr stage between 2 and 4.
Individuals with a MMSE score more than 24.
Ambulatory individuals with or without assistance.
Individuals with balance deficits (mPOMA score less than 23).
|
|
| ExclusionCriteria |
| Details |
Individuals with any pre-existing neurological disease other than PD.
Individuals with any magnetic-sensitive metallic implants close to the stimulation site.
Any systematic illness.
Presence of any orthopedic disease, visual problems, or vestibular disorders that could affect balance.
Surgery in lower limb and spine.
Non-cooperative individuals
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS)- Motor Part -III |
At baseline, day 7, day 15 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB) |
At baseline, Day 7, Day 15 |
| Quality of life-PDQL (Parkinson’s disease quality of life) |
At Baseline, day 7, day 15 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
21/04/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This study was a Randomized Controlled Trial (RCT) investigating the combined effect of Repetitive Transcranial Magnetic Stimulation (rTMS) and Task-specific Trunk Control Training on postural stability in individuals with Parkinson’s Disease (PD). A total of 16 participants met the inclusion criteria and completed the study. The study was conducted at multiple physiotherapy and neurorehabilitation centers in Patiala, India. Ethical approval was obtained, and informed consent was secured from all participants. Participants were randomly divided into two groups: Group A: Received rTMS, Task-specific Trunk Control Training, and Conventional Physiotherapy. Group B: Received Sham rTMS, Task-specific Trunk Control Training, and Conventional Physiotherapy. Assessments were conducted at baseline, Day 7, and Day 15 using: MDS-UPDRS-III (Movement Disorder Society-Unified Parkinson’s Disease Rating Scale - motor part m-CTSIB (Modified Clinical Test of Sensory Interaction in Balance) PDQL (Parkinson’s Disease Quality of Life Scale) The intervention lasted 3 weeks (5 days per week), with progressive exercises focusing on balance, trunk control, and functional mobility. Post-intervention data were analyzed to evaluate improvements in motor function, balance, and quality of life. |