| CTRI Number |
CTRI/2025/09/094199 [Registered on: 03/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Improving dynamic sitting balance after stroke by using core stability exercises and Non-Immersive virtual reality training. |
|
Scientific Title of Study
|
Effectiveness of Combined Core Stabilization Exercises Along with Non-Immersive Virtual Reality Training on Dynamic Sitting Balance in Subacute Stroke patient: A Pre-Post Single Group Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GEETHA S |
| Designation |
PG Resident |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences.. |
| Address |
3rd Floor,2nd Room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences,395 Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044.
3rd Floor,2nd Room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences,395 Sarojini Naidu Road, Sidhapudur, Coimbatore-641044.
Coimbatore
TAMIL NADU
641044
India |
| Phone |
7305281986 |
| Fax |
|
| Email |
geethasakthivel2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PORKODI R |
| Designation |
MPT(Neurology) |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences.. |
| Address |
3rd Floor, 2nd Room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences,395 Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044.
3rd Floor, 2nd Room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences,395 Sarojini Naidu Road, Sidhapudur, Coimbatore - 641044.
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PORKODI R |
| Designation |
MPT(Neurology) |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences.. |
| Address |
3rd Floor, 2nd Room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences,395 Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044.
3rd Floor, 2nd Room, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences,395 Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI RAMAKRISHNA MULTI SPECIALITY HOSPITAL,COIMBATORE. |
|
|
Primary Sponsor
|
| Name |
GEETHA S |
| Address |
3RD FLOOR, 2ND ROOM, COLLEGE OF PHYSIOTHERAPY,SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES, 395 SAROJINI NAIDU ROAD. 641 044,India. |
| 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 |
| GEETHA S |
Sri Ramakrishna Multi-Speciality Hospital. |
2nd Floor, Neurorehabilitation center, under Physical Medicine and Rehabilitation center,395 Sarojini Naidu Road, Sidhapudur, Coimbatore- 641044.
Coimbatore
TAMIL NADU |
7305281986
geethasakthivel2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hospital Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I693||Sequelae of cerebral infarction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Core stabilization exercises along with Non-Immersive Virtual reality training on Subacute stroke patients. |
The core stabilization intervention will consists 30 min session performed once per day,three days a week for four weeks. and The Non-Immersive Virtual reality intervention(trunk lateral flexion, trunk rotation) will consists of 30 min session conducted once per day,three days a week for four weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Age above 40-55 years.
2. Subacute stroke both ischemic(MCA)and hemorrhagic stroke.
3. Both gender
4. Able to sit independently for 1 min.
5. Mini Mental Scale Examination more than 24.
6. FIST score between 0-20. |
|
| ExclusionCriteria |
| Details |
1. Severe musculoskeletal issues
2. Visual or hearing impairement
3. Recent Orthopedic Surgeries
4. Concurrent neurological disorder(perceptual disorders, pusher syndrome, brainstem and cerebellar stroke)
5. Other comorbidities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improving dynamic sitting balance on subacute stroke patients BY Using Function in sitting test sacle. (FIST) |
After 4 weeks of intervention, the post test values will be measured. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NILL |
NILL |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
15/09/2025 |
| 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
|
stroke is a common global health care problem and frequently results in impaired postural control and reduced dynamic sitting balance, over 80% experience a balance disturbance in the subacute phase, it reduce ability to perform daily task, and at six month after stroke, 40% of stroke survivors have difficulties with basic activity of daily living. Here , virtual reality primarily enhances sensory feedback and motor learning but does not directly strengthen the deep core muscle responsible for postural stability , at the same time core stabilization exercises strengthen the trunk muscle and enhance proximal stability , but does not fully engage sensory motor integration and cognitive processing required for dynamic balance. However, there is limited research on whether combining these two methods is more effective to improve dynamic sitting balance than using them separately. so, The aim of the study is to improve dynamic sitting balance among subacute stroke patients by using core stabilization exercises and Non - Immersive virtual reality training. Based on purposive sampling method , A total of 20 subacute stroke patients who meet the inclusion criteria will be enrolled from Sri Ramakrishna multi speciality hospital from the department of neurorehabilitation center ,Baseline pre test assessment of dynamic sitting balance will be conducted using the Function in Sitting Test (FIST). Participants will then undergo intervention consisting of 30 min of core stabilization exercises, three days per week for four weeks, followed by 30 min of Non-Immersive Virtual Reality Training for 3 days a week for 4 weeks . After completion of the 4- week intervention program, post-test intervention assessment will be taken using the FIST to determine the effects on dynamic sitting balance. |