| CTRI Number |
CTRI/2025/09/095430 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| 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
|
Does square-stepping exercise improve balance and walking speed in people recovering from stroke? |
|
Scientific Title of Study
|
To study the effectiveness of
Square Stepping Exercise on Balance and
Gait velocity in post-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 |
Yuvasri H |
| Designation |
Post Graduate Student - Advanced Neurology |
| Affiliation |
Government Medical College and Hospital - Cuddalore |
| Address |
Room no. 313, Department of Physiotherapy, Division of PMR, Government Medical College and Hospital, Annamalai Nagar, Cuddalore Room no. 313, Department of Physiotherapy, Division of PMR, Government Medical College and Hospital, Annamalai Nagar, Cuddalore Cuddalore TAMIL NADU 608002 India |
| Phone |
9384649795 |
| Fax |
|
| Email |
yuvasrihemanathan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
R Sampath Pulimoot |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Hospital - Cuddalore |
| Address |
Department of PMR, Government Medical College and Hospital, Annamalai Nagar, Cuddalore
Cuddalore TAMIL NADU 608002 India |
| Phone |
9443449829 |
| Fax |
|
| Email |
sampulimoot@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
R Sampath Pulimoot |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College and Hospital - Cuddalore |
| Address |
Department of PMR, Government Medical College and Hospital, Annamalai Nagar, Cuddalore
Cuddalore TAMIL NADU 608002 India |
| Phone |
9443449829 |
| Fax |
|
| Email |
sampulimoot@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 313, Department of Physiotherapy, Division of PMR, Government Medical College and Hospital, Annamalai Nagar, Cuddalore - 608002 |
|
|
Primary Sponsor
|
| Name |
Yuvasri H |
| Address |
Department of PMR, Government Medical College and Hospital-Cuddalore, Annamalai Nagar, Cuddalore -608002 |
| 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 |
| Dr S Arul Pragassame |
Government Medical College and Hospital - Cuddalore |
Room no.313, Department of PMR, Government Medical College and Hospital—Cuddalore, Annamalai nagar,Cuddalore
Cuddalore TAMIL NADU |
98423 85544
arulphysio77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional physiotherapy |
Conventional physiotherapy program for balance and gait training, delivered 3 times per week for 6 weeks. This includes traditional balance exercises, gait training, and strengthening as per routine rehabilitation protocols. |
| Intervention |
Square Stepping Exercise along with Conventional physiotherapy |
quare Stepping Exercise (SSE) program: supervised progressive SSE protocol delivered 3 times per week for 6 weeks. Each session lasts 30 minutes and includes warm-up, structured stepping patterns on a 25-cell mat, progression of complexity, and cool-down. Delivered by a trained physiotherapist. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Stroke patients with unilateral or hemispherical diagnosed with CVA based on MRI and CT.
2.Patients aged between 45 and 60 years.
3.Patients with post-stroke duration from 3 to 9 months post stroke.
4.Patients with Fall Efficacy Scale score of 16.
5.Patients who can ambulate 10 metres independently.
6.Medically stable and cleared for physical activity by a physician.
7.Patients demonstrating Brunnstrom stage of recovery 3,4,5 indicating moderate motor recovery with potential for functional improvement.
8.Ability to comprehend and follow oral instruction
|
|
| ExclusionCriteria |
| Details |
1.Patients with other neurological conditions affecting motor function
2.Perceptual Dysfunction
3.More than one Episode of stroke
4.Patients with significant musculoskeletal disorders or lower limb injuries affecting mobility
5.Patients with uncorrected Auditory and visual Deficits
6.Patients with Aphasia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Berg Balance Scale
10-Meter Walk Test
|
9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
11/10/2025 |
| 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="10" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Stroke is a leading cause of long-term disability globally, frequently resulting in impaired balance and gait velocity, which in turn compromise functional mobility and increase fall risk (Langhorne et al., 2011). These motor deficits greatly impact the individual’s ability to perform daily activities independently, affecting their quality of life and social participation (Jørgensen et al., 1995). Among post-stroke individuals, impaired balance is one of the most significant predictors of falls and reduced community ambulation (Mao et al., 2002). Conventional physiotherapy has been shown to improve balance and gait after stroke; however, the high cost, need for specialized supervision, and long-term commitment often limit its accessibility, especially in low-resource or rural settings (Pollock et al., 2014). This underscores the importance of exploring scalable, task-specific, and cost-effective rehabilitation strategies that enhance recovery of balance and gait while promoting functional independence. Square Stepping Exercise (SSE) is a structured, low-cost, and adaptable exercise program that involves performing specific foot patterns on a gridded mat. Originally developed by Shigematsu and Okura to improve balance and prevent falls in older adults, SSE has shown promise in enhancing coordination, lower limb strength, and cognitive-motor integration. However, despite its proven utility in geriatric populations, SSE is not well established in stroke rehabilitation. The cognitive demand of memorizing and executing step sequences adds a dual-task component that may be particularly beneficial for stroke patients, who often exhibit deficits in both motor and cognitive domains. Therefore, exploring the efficacy of SSE in stroke recovery may provide a novel, evidence-based approach to enhancing post-stroke rehabilitation outcomes. |