| CTRI Number |
CTRI/2026/01/101311 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Enhanced External Counterpulsation Treatment on Autonomic Nervous System Function in Patients with Ischemic Stroke |
|
Scientific Title of Study
|
Efficacy of enhanced external counterpulsation (EECP) on autonomic function in ischemic stroke patients: A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bijil Johny |
| Designation |
Master of Physiotherapy |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Department of Physiotherapy, Institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7902418193 |
| Fax |
|
| Email |
bijiljohny@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Thrishala Noronha |
| Designation |
Dean and Associate professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Dean,
Institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district ,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9743201400 |
| Fax |
|
| Email |
thrish22.cp@srinivasuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Thrishala Noronha |
| Designation |
Dean and Associate professor |
| Affiliation |
Institute of Physiotherapy, Srinivas University |
| Address |
Dean,
Institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district ,575001
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9743201400 |
| Fax |
|
| Email |
thrish22.cp@srinivasuniversity.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bijil Johny |
| Address |
Master of physiotherapy student,institute of physiotherapy srinivas university ,city campus ,pandeshwara mangalore, dakshina kannada district,575001 |
| Type of Sponsor |
Other [Self ] |
|
|
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 |
| Bijil Johny |
Neurophysiotherapy OPD, Srinivas University |
Neurophysiotherapy Department, Institute of physiotherapy srinivas university ,city campus ,Room No. 1,pandeshwara, mangalore, dakshina kannada district ,575001
Dakshina Kannada
KARNATAKA |
07902418193
bijiljohny@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board And Ethical Committe (IRBEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I631||Cerebral infarction due to embolism of precerebral arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional exercise |
Strengthening exercises to upper and lower limb, fine motor exercises, gait training and balance training. |
| Intervention |
Enhanced External Counterpulsation (EECP) |
EECP is a machine which uses air filled cuffs wrapped around the calf, thigh and gluteal region which inflates synchronously to push the blood from the periphery giving perfusion to the brain. The intervention group also undergoes conventional physiotherapy treatment for stroke rehabilitation. 35 sessions of EECP will be given, 5 days per week for 7
weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Medically stable and referred for physiotherapy
Based on an Age-appropriate SDNN
First-ever ischemic stroke
MOCA Scale score of more than 26 |
|
| ExclusionCriteria |
| Details |
History of Atrial fibrillation (AF) (cardioembolic stroke) and Rheumatic heart disease
(RHD).
Evidence of Arteriovenous Malformation (AVM), Arteriovenous Fistula (AVF), or
aneurysm
A history of Intracerebral Haemorrhage, Brain tumour, or Malignancy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability including
Time domain
Frequency domain
Heart rate |
0
1 month
3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Tilt table testing
|
0
1 month
3 months |
| Sustained hand grip test |
0
1 month
3 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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 Yet Recruiting |
| 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 randomized controlled trial will investigate the efficacy of Enhanced External Counter pulsation (EECP) on autonomic functions in patients with ischemic stroke. The study aims to determine whether EECP, when combined with conventional rehabilitation, will improve autonomic nervous system regulation, which is commonly impaired following stroke. Patients with ischemic stroke will be randomly allocated into experimental and control groups. The experimental group will receive EECP therapy in addition to conventional physiotherapy, while the control group will receive conventional physiotherapy alone. Autonomic function will be assessed using heart rate variability parameters, including time-domain and frequency-domain measures, both before and after the intervention period. The outcomes will be analyzed to identify changes in autonomic balance. It is expected that the EECP group will demonstrate significant improvements in parasympathetic activity and a reduction in sympathetic dominance compared to the control group. These changes will suggest enhanced cerebral perfusion, enhance cardiovascular stability and overall rehabilitation outcomes. |