| CTRI Number |
CTRI/2026/02/103759 [Registered on: 12/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| 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
|
A New Way to Improve Walking After Stroke: Ear Stimulation Combined with Gait Training |
|
Scientific Title of Study
|
Enhancing Neuroplasticity and Gait Recovery in Chronic Stroke Survivors: A Randomized Controlled Trial of Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) Paired with Task-Specific Gait Training |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amit Jayant |
| Designation |
Master of Physiotherapy (Neurology) scholar |
| Affiliation |
Lovely Professional University |
| Address |
Physiotherapy department, School of allied medical science, Block 3, Room no. 105, Lovely Professional University, Jalandhar-Delhi G.T. Road, Phagwara, Punjab (India)-144411
Kapurthala
PUNJAB
144411
India |
| Phone |
9149298627 |
| Fax |
|
| Email |
amitjay.physio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Preeti Kapri |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Physiotherapy department, School of allied medical science, Block 3, Room no. 105, Lovely Professional University, Jalandhar-Delhi G.T. Road, Phagwara, Punjab (India)-144411
Kapurthala
PUNJAB
144411
India |
| Phone |
8859550200 |
| Fax |
|
| Email |
kapripreeti04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Preeti Kapri |
| Designation |
Assistant Professor |
| Affiliation |
Lovely Professional University |
| Address |
Physiotherapy department, School of allied medical science, Block 3, Room no. 105, Lovely Professional University, Jalandhar-Delhi G.T. Road, Phagwara, Punjab (India)-144411
Kapurthala
PUNJAB
144411
India |
| Phone |
8859550200 |
| Fax |
|
| Email |
kapripreeti04@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amit Jayant |
| Address |
Lovely Professional University, Jalandhar-Delhi G.T. Road, Phagwara, Punjab (India)-144411 |
| 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 |
| Amit Jayant |
LPU OPD |
Block-3, Room No. 105, Department of Physiotherapy, School of Allied Medical Sciences, Lovely Professional University, Jalandhar-Delhi G.T. Road, PHAGWARA, Punjab (India) - 144411
Kapurthala
PUNJAB |
9149298627
amitjay.physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-LPU |
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 |
| Comparator Agent |
Sham TaVNS with Gait Training |
Participants in the control group received sham TaVNS, with electrodes placed similarly but no therapeutic stimulation delivered, along with identical task-specific gait training matching the experimental group in duration, intensity, and progression. |
| Intervention |
TaVNS with Gait Training |
Participants received TaVNS via ear clip electrodes placed on the tragus and cymba conchae of the left ear, delivered concurrently with task-specific gait training. Stimulation was applied at 25 Hz, 300 µs pulse width, with intensity adjusted to a mild, comfortable tingling sensation. Gait training focused on weight shifting, gait symmetry, dynamic balance, and obstacle-based functional walking. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Chronic stroke survivors more than 6 months post stroke
Stable medical condition no recent hospitalizations or major changes in therapy in past 3 months
Cognitive ability to follow simple instructions MMSE more than 18
Brunnstrom stages more than 3
|
|
| ExclusionCriteria |
| Details |
Cognitive impairement
, Cardiovascular conditions, Peripheral neuropathy or orthopedic conditions affecting gait, History of epilepsy or seizure disorders, Allergy or hypersensitivity to electrode adhesives or stimulation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Timed Up and Go (TUG) Test
Functional Independence Measure – Motor Component (FIM-Motor) |
0 Week, 3 Week, 6 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cadence |
0 Week, 3 Week, 6 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)
|
22/02/2026 |
| 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="0"
Months="2"
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 randomized, sham-controlled clinical trial designed to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (TaVNS) combined with task-specific gait training in individuals with chronic stroke. Thirty participants aged 45–80 years and at least six months post-stroke will be recruited and randomly allocated into two groups. The experimental group will receive active TaVNS along with task-specific gait training, while the control group will receive sham TaVNS with identical gait training. The intervention will be conducted five days per week for six weeks. Outcome measures will be assessed at baseline, mid-intervention (3 weeks), and post-intervention (6 weeks). Functional mobility will be evaluated using the Timed Up and Go (TUG) test, functional independence using the Functional Independence Measure (Motor component), spatiotemporal gait performance using cadence. The study aims to determine whether adding TaVNS to gait training results in greater improvements in gait-related functional outcomes compared to gait training alone in chronic stroke survivors. |