| CTRI Number |
CTRI/2024/10/074630 [Registered on: 03/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Immediate Effect Of Muscle Energy Technique(MET)On Lower Limb Spasticity, Muscle Length And Gait In Chronic Stroke Patients |
|
Scientific Title of Study
|
Immediate Effect Of Muscle Energy Technique(MET)On Lower Limb Spasticity, Muscle Length And Gait In Chronic Stroke Patients- A Single Group Pre- Post Experimental Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Hirdaynarayan Yadav |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Srinivas of physiotherapy ,Srinivas University |
| Address |
Department of physiotherapy,institute of physiotherapy,srinivas university ,pandeshwar CAMPUS,MANGALURU ,dakshin kannada,Karnataka,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8320961107 |
| Fax |
|
| Email |
sneha1401yadav@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Thrishala Noronha |
| Designation |
Associate Professor |
| Affiliation |
Institute Of Physiotherapy ,Srinivas University |
| Address |
Department of Physiotherapy,Institute of Physiotherapy, Srinivas University,Pandeshwar Campus,Managaluru ,Dakshina Kannada,Karnataka,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9743201400 |
| Fax |
|
| Email |
thrish22.cp@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Sneha Hirdaynarayan Yadav |
| Designation |
Master of Physiotherapy student |
| Affiliation |
Institute of physiotherapy ,Srinivas University |
| Address |
Department of Physiotherapy,Institute of Physiotherapy, Srinivas University,Pandeshwar Campus, Mangaluru ,Dakshin Kannada,Karnataka,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8320961107 |
| Fax |
|
| Email |
sneha1401yadav@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy Institute of physiotherapy, Srinivas University, Pandeshwar, Mangalore, Karnataka, 575001 |
|
|
Primary Sponsor
|
| Name |
SnehaHYadav |
| Address |
Institute Of Physiotherapy,Srinivas University Pandeshwar Campus,Mangaluru ,Dakshin Kannada,Karnataka |
| Type of Sponsor |
Other [Post graduate student ] |
|
|
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 |
| SNEHA H YADAV |
INSTITUTE OF PHYSIOTHERAPY,SRINIVAS UNIVERSITY |
DEPARTMENT OF PHYSIOTHERAPY,INSTITUE OF PHYSIOTHERAPY,SRINIVAS UNIVERSITY,PANDESHWAR CAMPUS,MANGALURU,DAKSHINA KANNADA,KARNATAKA,575001
Dakshina Kannada
KARNATAKA |
08320961107
sneha1401yadav@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRINIVAS UNIVERSITY ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Muscle Energy Technique |
Muscle Energy Technique(MET)on Lower limb Spasticity,Muscle Length and Gait in Chronic Stroke for 5 Sessions/Week for 4 Weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Stroke Patients,Duration of Stroke more than 6 months,both the genders,age 40-70 years,spasticity level Grade- 2,3
According to Modified Tardieu Scale Grading |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Tardieu Scale
Muscle length
Dynamic gait Index |
Base line
1st week
2nd week
3rd week
4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/10/2024 |
| 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) |
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
|
The document titled "Immediate Effect of Muscle Energy Technique (MET) on Lower Limb Spasticity, Muscle Length, and Gait in Chronic Stroke Patients" is a pre-post experimental study that investigates the application of MET on stroke survivors. The primary goals are to determine the effects of MET on lower limb spasticity, muscle length, and gait in chronic stroke patients to assess MET’s impact on lower limb spasticity using the Modified Tardieu Scale.To measure muscle length improvements with a Universal Goniometer,To evaluate gait changes using the Dynamic Gait Index.A sample of 30 chronic stroke patients aged 40–70 will undergo MET sessions over four weeks.Outcomes will be measured before and after the intervention.If MET proves effective, it can be integrated into stroke rehabilitation to improve patient outcomes related to spasticity, muscle length, and gait. |