| CTRI Number |
CTRI/2026/03/106147 [Registered on: 13/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to Assess Whether Brain-Computer Interface Training Helps Improve Arm Movement in People After Stroke |
|
Scientific Title of Study
|
EFFECTIVENESS OF BRAIN COMPUTER INTERFACE TRAINING ON UPPERLIMB FUNCTION RECOVERY 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 |
Dr Helan hanna cherian |
| Designation |
Senior Physiotherapist |
| Affiliation |
2050 healthcare banglore |
| Address |
2050 Healthcare, MCEHS Layout, RK Hegde Nagar, Bangalore,
560077
Bangalore
KARNATAKA
560077
India |
| Phone |
8078063392 |
| Fax |
|
| Email |
helancheriyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purnima Singh |
| Designation |
Principal |
| Affiliation |
Hosmat college of physiotherapy |
| Address |
Sy No 5/2, Bethel street, Near laggere main road, Bengaluru-560058
Bangalore
KARNATAKA
560058
India |
| Phone |
9886367792 |
| Fax |
|
| Email |
purnimasingh29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Helan hanna cherian |
| Designation |
Senior Physiotherapist |
| Affiliation |
2050 healthcare |
| Address |
2050 Healthcare, MCEHS Layout, RK Hegde Nagar, Bangalore,
560077
Bangalore
KARNATAKA
560077
India |
| Phone |
8078063392 |
| Fax |
|
| Email |
helancheriyan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Helan Hanna Cherian |
| Address |
2050 Healthcare, MCEHS Layout, RK Hegde Nagar. Bengaluru-560077 |
| Type of Sponsor |
Other [2050 Healthcare Neuro Rehabilitation centre] |
|
|
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 Helan hanna cherian |
2050 Healthcare |
2050 Healthcare, MCEHS Layout, RK Hegde Nagar, Bangalore,
560077
Bangalore
KARNATAKA |
8078063392
helancheriyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hosmat Hospital Educational Institute college of Physiotherapy |
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: G00-G99||Diseases of the nervous system, (3) ICD-10 Condition: G00-G99||Diseases of the nervous system, (4) ICD-10 Condition: I691||Sequelae of nontraumatic intracerebral hemorrhage, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brain Computer Interface |
Participants will undergo Brain–Computer Interface (BCI)–assisted motor imagery training for upper limb rehabilitation following stroke. Electroencephalography (EEG) signals will be recorded using a non-invasive scalp electrode cap while participants perform guided motor imagery tasks (imagining movement of the affected upper limb). The BCI system will decode sensorimotor rhythms associated with motor imagery and provide real-time feedback through visual display and/or activation of assistive modalities such as functional electrical stimulation (FES) or robotic assistance to the affected limb. Each session will begin with system calibration followed by structured motor imagery tasks targeting the affected upper limb. Real-time feedback will be provided to reinforce correct motor imagery patterns.This will be conducted 3 days a week for 8 weeks which is 24 session. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Both genders
Age – 18 years and above
Clinically diagnosed Stroke either by MRI or by referred physicians.
Referred by Physician for upper limb rehabilitation
Willing to participate in the therapy
|
|
| ExclusionCriteria |
| Details |
Stroke due to TBI or any other neurological conditions.
History of epilepsy or seizures
Patients with severe cognitive impairments
Patients with any upper limb complications like subluxation or Shoulder hand syndrome.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nine Hole Peg Board Test |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Upper Limb Functions |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
03/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/05/2026 |
| 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
|
Traditional stroke rehabilitation relies on repetitive voluntary movements, which many patients with severe paresis cannot perform, and recovery often plateaus within six months. Brain–Computer Interface (BCI) technology offers an alternative by enabling patients to perform motor imagery with real-time feedback, bypassing damaged motor pathways and promoting neuroplasticity without physical movement. Although early studies show promise, optimal protocols for treatment duration and feedback methods remain unclear. If effective, BCI-based rehabilitation could provide personalized, home-based therapy for patients with severe impairments and may be further enhanced by integration with technologies such as robotics, virtual reality, and functional electrical stimulation. |