| CTRI Number |
CTRI/2025/07/091509 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Balance Training On Chronic Stroke Patients |
|
Scientific Title of Study
|
Effectiveness Of Star Excursion Balance Training On Chronic 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 |
Mobarak Hossain |
| Designation |
Masters of Physiotherapy |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Nopany Institute of Healthcare Studies, 2C, Nanda Mullick Lane, Girish park, physiotherapy department, Kolkata
Kolkata
WEST BENGAL
700006
India |
| Phone |
7908048034 |
| Fax |
|
| Email |
mhossain822a@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anwesh Pradhan |
| Designation |
Associate Professor |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Department of Physiotherapy, Nopany Institute of Healthcare Studies, Kolkata
Kolkata
WEST BENGAL
700006
India |
| Phone |
8240137205 |
| Fax |
|
| Email |
anwesh@nihs.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Tapas Kumar Pal |
| Designation |
Assistant Professor |
| Affiliation |
Nopany Institute of Healthcare Studies |
| Address |
Department of Physiotherapy, Nopany Institute of Healthcare Studies, Kolkata
Kolkata
WEST BENGAL
700006
India |
| Phone |
9804257395 |
| Fax |
|
| Email |
tapas@nihs.ac.in |
|
|
Source of Monetary or Material Support
|
| Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, Pin- 700006 |
|
|
Primary Sponsor
|
| Name |
Nopany Institute of Healthcare Studies |
| Address |
Nopany Institute of Healthcare Studies, Kolkata, West Bengal, India, Pin- 700006 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Mobarak Hossain PT |
Nopany Physiotherapy |
2C, Nanda Mullick Lane, Nutan Bazar, Girish Park, Jorasanko, Kolkata, West Bengal, Pin- 700006
Kolkata
WEST BENGAL |
7908048034
mhossain822a@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nopany Institute of Healthcare Studies Ethics Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Balance Training |
3 sessions/weeks, for 4 weeks |
| Intervention |
Star Excursion Balance Training |
3 sessions/weeks, for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Chronic stroke patients of all genders.
2. Age between 40 to 65 years.
3. Stroke that lasts longer than six months.
4. Mini-mental State Examination scale score greater than or equal to 24.
5. Patients, able to stand and walk with minimal assistance. |
|
| ExclusionCriteria |
| Details |
1. A history of unstable Cardiac issues.
2. Additional health issues that impair gait, balance, or cause pain or discomfort that prevent exercise.
3. The existence of deformities, contractures, or tightness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Static Balance
2. Dynamic Balance |
4 weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
10/08/2025 |
| 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="2"
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
|
Stroke is a leading cause of death and long-term disability worldwide, particularly affecting mobility and balance due to neuromuscular and sensory impairments. Balance deficits are common in stroke survivors, with prevalence ranging from 36.8% to 83%, and are strongly associated with increased fall risk and reduced functional independence. Effective rehabilitation requires targeted balance training. While Conventional Balance Training (CBT) has shown proven benefits for improving balance in stroke patients, the Star Excursion Balance Training (SEBT) — a dynamic and multidirectional technique — has primarily been validated in orthopedic and athletic populations. Only limited evidence exists on SEBT’s application in stroke, with minimal research on its impact on static and dynamic balance in chronic stroke survivors. This study aims to compare the effectiveness of SEBT and CBT in improving balance in individuals with chronic stroke. Purpose of the study: The primary purpose of this study is to evaluate and compare the effectiveness of Star Excursion Balance Training (SEBT) and Conventional Balance Training (CBT) in improving static and dynamic balance in individuals with chronic stroke. The primary purpose of this study is to evaluate and compare the effectiveness of Star Excursion Balance Training (SEBT) and Conventional Balance Training (CBT) in improving static and dynamic balance in individuals with chronic stroke. Methodology: The patient will be selected based on inclusion and exclusion criteria. Group A will be perform Star Excursion Balance training and Group B will perform Conventional Balance training program for 4 weeks 3 sessions per week. Statistical Analysis: The statistical analysis will be conducted using SPSS software version 25. The primary analysis will be used descriptive statistics to analyse the demographic data. Pre (baseline) and post (after 4 weeks) intervention data will be collected. Student t-tests will be used for the inter-group and within-group data analysis. The level of significance will be considered upon p-value = 0.05. |