| CTRI Number |
CTRI/2025/07/090467 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study on effect of balance training with eyes open versus eyes closed on balance and walking ability in stroke patients. |
|
Scientific Title of Study
|
Blindfolded versus Free Vision:Impact on Balance and Gait rehabilitation in stroke survivors |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kongaiya B |
| Designation |
Master of Physiotherapy Student |
| Affiliation |
The Tamil Nadu Dr MGR Medical University |
| Address |
No 24, Murugan Illam, Muthukumar Nagar 4th Street, Rathinapuri Coimbatore
No 395, College of Physiotherapy, Sri Ramakrishna Institute of Paramedical Sciences, Sarojini Naidu Road, New Siddhapudhur, Coimbatore
Coimbatore
TAMIL NADU
641027
India |
| Phone |
8610850209 |
| Fax |
|
| Email |
aakashkongaiya2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R.Porkodi |
| Designation |
Professor in Physiotherapy |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY, SRI RAMAKRISHNA INSTITUTE OF PARAMEDICAL SCIENCES |
| Address |
No 395, College of Physiotherapy, Sri Ramakrishna Institute of paramedical sciences, New Siddhapudhur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9443820164 |
| Fax |
|
| Email |
porkodi.mpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kongaiya B |
| Designation |
Master Of physiotherapy student |
| Affiliation |
The Tamil Nadu Dr MGR Medical University |
| Address |
no 395, College of physiotherapy, Sri Ramakrishna Institute of paramedical sciences, New Siddhapudur, Coimbatore
No 395, College Of physiotherapy, Sri Ramakrishna Institute Of Paramedical Sciences, New Siddhapudur
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8610850209 |
| Fax |
|
| Email |
aakashkongaiya2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro Rehabilitation centre, Sri Ramakrishna Multispeciality Hospital, No 395, Sarojini Naidu Road, New Siddhapudhur, Coimbatore |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Kongaiya B |
Sri Ramakrishna Multi-speciality Hospital |
No 395, Sarojini Naidu Road, New Siddhapudur,
Coimbatore
TAMIL NADU |
8610850209
aakashkongaiya2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRIHNA HOSPITAL ETHICAL COMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blindfolded balance training |
Balance training will be carried out in stroke patients in blindfolded manner on alternate days for a period of 4 weeks |
| Comparator Agent |
Free Vision balance training |
Balance training Will be carried out without blindfold on alternate days for a period of 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Both Ischaemic and Haemorrhagic stroke
single cerbrovascular insult
Middle cerebral artery syndrome
Brunnstorm recovery stage of 4,5 and 6
Cognitive status ( MMSE greater than or equal to 24)
Berg Balance score ranging between 21-40
Patients without visual impairement
Subjects who can stand without assistance |
|
| ExclusionCriteria |
| Details |
Medical Comorbidities
Any other neurological or orthopaedic condition affecting gait performance
History of perceptual disorders
Vestibular disorders
Auditory deficits
Patients who cannot understand the procedure
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Balance |
Balance will be assessed at the baseline and at the end of 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait |
gait will be assessed at the baseline & at the end of 4 weeks |
|
|
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)
|
20/07/2025 |
| 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="0"
Months="8"
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
|
WALKING AND BALANCE IMPAIREMENTS ARE COMMON SEQUEALE OF STROKE AND THEY IMAPCT FUNC TIONAL INDEPEDENCE MORTALITY AND MORBIDITY ADEQUATE BALANCE IS A PREREQUSISTE FOR INDEPENDENT WALKING THAT REQUIRES SUFFICIENT INTEGRATION OF SENSORY INFORMATION VISIUALSOMATOSENSORY AND VESTIBULAR SYSTEM THE SUNCONSCIOUS ABILITY OF TO ENHANCE ONE TYPE OF SENSORY INPUT TO COMPENSATE FOR ABSENT INFORMATION IS TERMED AS SENSORY REWEIGHTHING WHICH IS AFFECTED IN STROKE THAT MAY LEAD TO BALANCE IMPAIREMENT APART FROM OTHER CAUSES BLINDFOLDED BALANCE TRAINING IS A SENSORY MOTOR STRATEGY AIMED AT MANIPULATING VISUAL INPUT TO ENHANCE THE USE OF UNDERUSED SOMATOSENSORY SYSTEM FOR BALANCE RECOVERY BY SUPPRESSING THE USE OF EXCESSIVE VISUAL DEPENDANCE. |