| CTRI Number |
CTRI/2023/10/059141 [Registered on: 26/10/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
A study to find out to different physiotherapy exercise on balance and gait in subacute stroke patients - a comparative study |
|
Scientific Title of Study
|
A study to find out the effect of square stepping exercise versus backward walking on balance and gait analysis in subacute stroke patients - a comparative 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 |
Princee Ashwinbhai Bhanderi |
| Designation |
Post Graduate student |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
School of Physiotherapy, RK University,
Kasturbadham, Rajkot-Bhavnagar
Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
9798434343 |
| Fax |
|
| Email |
pbhanderi268@rku.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hiral Mehta |
| Designation |
MPT in Neuromuscular Science |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
School of Physiotherapy, RK University,
Kasturbadham, Rajkot-Bhavnagar
Highway, Rajkot, Gujarat, India
Rajkot
GUJARAT
360020
India |
| Phone |
7600801186 |
| Fax |
|
| Email |
hiral.mehta@rku.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hiral Mehta |
| Designation |
MPT in Neuromuscular Science |
| Affiliation |
School of Physiotherapy, RK University. |
| Address |
School of Physiotherapy, RK University,
Kasturbadham, Rajkot-Bhavnagar
Highway, Rajkot, Gujarat, India
GUJARAT
360020
India |
| Phone |
7600801186 |
| Fax |
|
| Email |
hiral.mehta@rku.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Physiotherapy, RK University. |
|
|
Primary Sponsor
|
| Name |
Princee Ashwinbhai Bhanderi |
| Address |
School of Physiotherapy, RK University,
Kasturbadham, Rajkot-Bhavnagar
Highway, Rajkot, Gujarat, India |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| School of Physiotherapy RK University |
School of Physiotherapy, RK University,
Kasturbadham, Rajkot-Bhavnagar
Highway, Rajkot, Gujarat, India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Princee Bhanderi PT |
RK Physiotherapy and Rehabilitation Research Center |
Room no 1, Opp. Meghani Rang bhavan, 80 feet Road, Bhakti Nagar Cir, Rajkot, Gujarat 360002
Rajkot
GUJARAT |
9798434343
pbhanderi268@rku.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, School of Physiotherapy,RK Univesity |
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 |
| Comparator Agent |
Backward Walking |
Backward Walking and Conventional Physiotherapy will be given 5 times a week for 3 weeks |
| Intervention |
Square Stepping exercise |
Square Stepping Exercise and Conventional Physiotherapy will be given 5 times a week for 3 weeks |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age: 30 to 70 years
Gender: Both male and female
Individuals with subacute stroke
Individuals who are radiologically diagnosed with stroke
Individuals who have completed the Timed Up and Go Test in less than 20 seconds
Individuals who are capable of walking independently
|
|
| ExclusionCriteria |
| Details |
Visual, auditory and vestibular impairments
Individuals who are not willing to participate
Individuals who are not capable of walking independently
Patients who have cognitive and perceptual impairments
Recent fracture or surgery of lower limb
Unstable cardiovascular conditions
Other balance disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Performance Oriented Mobility
Assessment Scale |
At baseline and after 3 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
10/11/2023 |
| 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="3"
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
|
Title: A Study to Find Out the Effect of Square Stepping Exercise and Backward Walking on Balance and Gait Analysis in Subacute Stroke Patients – A Comparative Study
Investigator: Dr. Princee Bhanderi; PT, Dr. Hiral Mehta; MPT, School of Physiotherapy RK University.
Background: The term stroke is defined as the sudden demise of certain brain cells due to oxygen deprivation, caused by an interruption of the blood flow through an arterial blockage or rupture. Square stepping exercise involves moving in specific patterns resembling the shape of a square. During the square stepping exercise, individuals step forward, sideways, and diagonally, following the predetermined path on the ground. Backward walking involves walking in reverse, which challenges the body’s proprioceptive pathways. Performance Oriented Mobility Assessment developed by Tinetti provides a reliable measure of balance and gait. The total score for the balance assessment is 16, the total score for the gait assessment is 12 and the total test score is 28.
Method: A total 30 subacute stroke patients will be selected as per inclusion and exclusion criteria by purposive sampling from various physiotherapy centers in and around Jamnagar and Rajkot. After taking consent and assessment of all subjects they will be divided into 2 groups, group A and group B. Afterwards, gait and balance will be measured in both groups by the Tinetti Performance Oriented Mobility Assessment. Square Stepping Exercise 5 times a week for 3 weeks, will be given to group A and Backward Walking 5 times a week for 3 weeks, will be given to group B. The outcome measure will be taken on the first day of the first week and the last day of the third week. The pre and post-data of the outcome measures will be assessed using SPSS.
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