| CTRI Number |
CTRI/2025/02/081081 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
use of assisted Treadmill training and Strengthening exercises to improve walking and brain recovery in Stroke patients. |
|
Scientific Title of Study
|
Investigating the impact of Aerobic & Strengthening Exercise on Lower Limb Strength, Walking Performance and Neuroplasticity. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Urvashi Sharma |
| Designation |
Physiotherapist and Post graduate student |
| Affiliation |
|
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103
Kolar
KARNATAKA
563103
India |
| Phone |
7619421828 |
| Fax |
|
| Email |
urvashikhannal666@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarulatha H |
| Designation |
Professor and Guide |
| Affiliation |
Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103 |
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103
Kolar
KARNATAKA
563103
India |
| Phone |
9686235790 |
| Fax |
|
| Email |
charuparthe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarulatha H |
| Designation |
Professor and Guide |
| Affiliation |
Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103 |
| Address |
R.L. Jalappa College of Physiotherapy, Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103
Kolar
KARNATAKA
563103
India |
| Phone |
9686235790 |
| Fax |
|
| Email |
charuparthe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research Center, Kolar, Karnataka,563101 |
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research Center, Kolar, Karnataka,563101 . |
| Address |
Sri Devaraj Urs Academy of Higher Education and Research Center, Kolar, Karnataka,563101 . |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sarulatha H |
R.L Jalappa College of Physiotherapy |
R.L. Jalappa College of Physiotherapy, Neurophysiotherapy Unit,Room Number 07 ,Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103
Kolar
KARNATAKA |
09686235790
charuparthe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Devaraj Urs Academy of Higher education and Research, Tamaka, Kolar, Karnataka, 563103 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, (2) ICD-10 Condition: G460||Middle cerebral artery syndrome, (3) ICD-10 Condition: G461||Anterior cerebral artery syndrome, (4) ICD-10 Condition: G462||Posterior cerebral artery syndrome, (5) ICD-10 Condition: G467||Other lacunar syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
aerobic and strengthening exercises for the lower limb muscles in the stroke patients |
high intensity interval treadmill training for improving the aerobic capacity and strengthening exercise of lower limbs muscles with weight cuffs . The intervention shall be given for 3 months. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ischemic or hemorrhagic stroke, post stroke patients who is able to walk for 6 meters, stroke patients who are able to follow the commands, unilateral paralysis, stable cardiovascular system, brunnstrom recovery stage 3 and above |
|
| ExclusionCriteria |
| Details |
multiple strokes, history of cognitive, mental, visual, neurological disorders, pacemaker or implanted defibrillator, hospitalization for cardiopulmonary diseases within 3 months, lower extremity claudication, Modified Ashworth Scale more than 2 ,lower limb weight pain bearing more than 4 by 10, associated lower limb musculoskeletal disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
6-minute walk test
10- meter walk test
handheld dynamometer |
before start of intervention and after 3 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| brain derived neurotrophic factor, vascular endothelial growth factor. |
3 months |
|
|
Target Sample Size
|
Total Sample Size="23"
Sample Size from India="23"
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)
|
10/03/2025 |
| 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="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
|
This study is a quasi-experimental, interventional study investigating the impact of aerobic and strengthening exercise on lower limb strength, walking performance and neuroplasticity in stroke patients . The intervention period is 3 months in 23 Stroke patients from age 45 to 60 years old that will be conducted in Physiotherapy Out patient department of R.L. Jallapa Hospital, Kolar, Karnataka, India. The primary outcome measures will be 6minute walk test, 10 meter walk test, Handheld Dynamometer. The secondary outcome measure will be Brain Derived Neurotrophic factor and Vascular endothelial growth factor. |