| CTRI Number |
CTRI/2025/05/087362 [Registered on: 22/05/2025] Trial Registered Prospectively |
| Last Modified On: |
20/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To know the Effectiveness of task oriented strength training on upper limb spasticity by using modified ashworth scale grip strength by using modified phygmomanometer and activities of daily living by barthel index among subjects with sub acute stroke |
|
Scientific Title of Study
|
Effect of task oriented strength training on upper limb spasticity grip strength and activities of daily living among subjects with sub acute stroke |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanna muniramya |
| Designation |
MPT Neurology |
| Affiliation |
SVIMS |
| Address |
Sri venkateswara institute of medical sciences tirupathi andhrapradesh
Sri venkateswara institute of medical sciences tirupathi andhrapradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
7075128416 |
| Fax |
|
| Email |
kannamuniramya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V srikumari |
| Designation |
Associate professor |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Sri venkateswara institute of medical sciences tirupathi andhrapradesh
Sri venkateswara institiute OF medical sciences tirupathi andhrapradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9490181120 |
| Fax |
|
| Email |
Vadlamudi _jyo@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanna muniramya |
| Designation |
MPT Neurology |
| Affiliation |
Sri venkateswara institute of medical sciences |
| Address |
Sri venkateswara institute of medical sciences tirupathi andhrapradesh
Sri venkateswara institute of medical sciences tirupathi andhrapradesh
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
7075128416 |
| Fax |
|
| Email |
kannamuniramya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri venkateswara institute of medical sciences Tirupathi Andhrapradesh India 517507 |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Kanna Muniramya |
Sri venkateswara institute of medical sciences |
Sri venkateswara ayurvedic hospitals shalakya ward
General ward padmavathi hospital 2nd floor
Neurology Ward padmavathi hospital 4th floor
tirupathi andhrapradesh
Chittoor
ANDHRA PRADESH |
7075128416
kannamuniramya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri venkateswara institute of medical sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G94||Other disorders of brain in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A
Task oriented strength training |
For group A (experimental group)
Take oriented strength training
Duration 30 minutes per day for 5 days a week for 6 Week S
Electrical stimulation
Duration 15 minutes per day for 5 days a week for 6 weeks
Conventional therapy
Duration 15 minutes per day for 5 days a week for 6 weeks |
| Comparator Agent |
Group b(control group)
Electrical stimulation
Home Exercises
Conventional Therapy |
Electrical stimulation
Duration 15 minutes per day for 5 days a week for 6 weeks
Home Exercise S
Duration 30 minutes per day for 5 days a week for 6 weeks
Conventional Therapy
Duration 15 minutes per day for 5 days a week for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Ischemic stroke
MMSE less than 23
VCG 4
MAS 2
|
|
| ExclusionCriteria |
| Details |
Recurrent stroke
Cardiac pacemaker
Sensory impairment |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Ashworth Scale
Modified Sphygmomanometer test |
Modified Ashworth Scale is measured pre test by immediately and post test at end of 6th week
Modified Sphygmomanometer Test
Measured at pre test immediately and post test value by end of 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barthel index |
Measured immediately as pre test value
post test value by end of 6th week |
|
|
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)
|
15/06/2025 |
| 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="6"
Days="2" |
|
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
|
This is a prospective study. Study will commence after getting CTRI REF no .30 stroke subjects of 40-65 years of age group will be recruited by simple randomization technique lottery method based on inclusion and exclusion criteria. This study to know the effectiveness of task oriented strength training on upper limb spasticity grip Strength and activities of daily living in Subjects with subacute stroke
|