| CTRI Number |
CTRI/2025/06/089574 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
17/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
immediate effect of Matrix rhythm therapy on restricted movement of lower limb muscles, range of motion of lower limb, and balance in stroke patients. |
|
Scientific Title of Study
|
Immediate effect of Matrix rhythm therapy on spasticity of lower limb muscles, range of motion of lower limb, and balance in stroke patients. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nisha Sanjeev Biradar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9699359259 |
| Fax |
|
| Email |
nishabiradar5322@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shilpa Khandare |
| Designation |
Associate professor |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8149853651 |
| Fax |
|
| Email |
Shilpa.khandare@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nisha Sanjeev Biradar |
| Designation |
Post Graduate Student |
| Affiliation |
Dr. D. Y. Patil College of Physiotherapy |
| Address |
Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
MAHARASHTRA
411018
India |
| Phone |
9699359259 |
| Fax |
|
| Email |
nishabiradar5322@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR.D. Y. Patil College of Physiotherapy,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Nisha Sanjeev Biradar |
| Address |
Dr. D. Y. Patil College of Physiotherapy,90, Dr DY Patil College Rd, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018 |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 |
| Dr Nisha Sanjeev Biradar |
Dr. D. Y. Patil College of Physiotherapy OPD |
Physiotherapy OPD,Dr. D. Y. Patil College of Physiotherapy, Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
9699359259
nishabiradar5322@gmail.com |
| Dr Nisha Sanjeev Biradar |
Dr. D. Y. Patil Medical College, Hospital & Research Centre |
Physiotherapy Department,Sant Tukaram Nagar, Pimpri Colony, Pimpri-Chinchwad, Maharashtra 411018
Pune
MAHARASHTRA |
9699359259
nishabiradar5322@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: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Matrix Rhythm Therapy |
Patient Explanation: Inform the patient about how the Matrix Rhythm Therapy (MRT) device works, describing the rhythmic vibrations and potential sensations such as mild tingling or warmth.
Device Setup: Position the patient comfortably and attach the MRT device to the muscles.
Treatment Application: Move the device along the muscle fibers , applying rhythmic vibrations smoothly.
Session Duration: Administer therapy for about 60 minutes, monitoring the patients comfort and encouraging feedback throughout.
total duration of the treatment - 60 minutes |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed with stroke
2.Modified Modified Ashworth Scale between 1–3 for the lower extremity.
3.Could understand the content and co-operate for evaluation and treatment
4.TUG test 20-29 seconds
|
|
| ExclusionCriteria |
| Details |
1.Cardiac pacemaker
2.Aphasia
3.Open wounds in the areas to be treated
4.Circulatory problems
5.Skin lesions
6.Other neurological problems
7.Psychiatric problems and/or orthopaedic problems
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MODIFIED TARDIEU SCALE
Digital UNIVERSAL GONIOMETER
TIMED UP AND GO TEST. |
Pre intervention and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/07/2025 |
| Date of Study Completion (India) |
02/02/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/02/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| 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
|
PURPOSE:
This study aims to
explore the immediate effects of Matrix Rhythm Therapy (MRT) on spasticity,
range of motion and balance in stroke patients. Spasticity and limited mobility
can slow down recovery and affect rehabilitation outcomes. If proven effective,
MRT may improve mobility and quality of life, making it a valuable addition to
stroke rehabilitation programs.
METHODS:
STUDY DESIGN : Pre-Post study
STUDY SETTING :
Dr. D.Y. Patil Hospital and
Research Center.
Dr D.Y. Patil College Of Physiotherapy OPD , Pimpri Pune
TARGET POPULATION : Stroke
SAMPLING METHOD :
Purposive Sampling
SAMPLE SIZE : The estimated sample size for the study is
32 participants the
estimation is calculated using
winpepi version 11.65. based on
confidence level of 95% an acceptable difference of 0.32.
PROCEDURE:
•
Pre-Treatment Assessment And Post-treatment Assessment: Evaluate spasticity using Modified
tardieu scale, Range of motion using digital goniometer and balance with the
Timed Up and Go Test.
•
Intervention: Matrix
rhythm therapy for 60min , targeting hamstring and gastrocnemius muscle.
•
Follow-up :
after 2weeks.
|