| CTRI Number |
CTRI/2024/09/073763 [Registered on: 11/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the difference of the effectiveness of otago exercise program and square stepping exercise on walking and balance in persons with one side paralysis |
|
Scientific Title of Study
|
Compare the effect of otago exercise program and square stepping exercise on gait and balance in individuals with hemiparesisa |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karsandas Ekta KintKumar |
| Designation |
Post Graduate |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences near SP Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad
Ahmadabad
GUJARAT
380060
India |
| Phone |
7226936909 |
| Fax |
|
| Email |
ektasoni235@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Suthar |
| Designation |
Lecturer PhD and PG guide |
| Affiliation |
Ahmedabad Institute of Medical Sciences |
| Address |
Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences near SP Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad
Ahmadabad
GUJARAT
380060
India |
| Phone |
9913806872 |
| Fax |
|
| Email |
vaishu82in@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Suthar |
| Designation |
Lecturer PhD and PG guide |
| Affiliation |
Ahmedabad Institute Of Medical Sciences |
| Address |
Room No 01 Division Exercise Therapy Department Physiotherapy Ahmedabad Institute of Medical Sciences near SP Ring Road Ognaj Circle Gota-Kalol Highway Lapkaman Ahmedabad
Ahmadabad
GUJARAT
380060
India |
| Phone |
09913806872 |
| Fax |
|
| Email |
vaishu82in@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ahmedabad Institute of Medical Sciences, AIMS campus near Lions karnavati eye hospital , Lapkaman, Gota-Vadsar, Ahmedabad Gujarat 380060 |
| Karsandas Ekta Kintkumar, AIMS campus near Lions karnavati eye hospital , Lapkaman, Gota-Vadsar, Ahmedabad Gujarat 380060 |
|
|
Primary Sponsor
|
| Name |
Karsandas Ekta KintKumar |
| Address |
AIMS campus near SP ring road ognaj circle near Lions Karnavati Eye hospital Gota Kalol highway Lapkaman Ahmedabad 380060 |
| 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 Vaishali Suthar |
Ahmedabad institute of medical sciences |
Room no 01 Division Exercise Therapy Department physiotherapy , AIMS campus , near SP ring road, Ognaj circle, Gota-Kalol highway, Lapkaman, Ahmedabad
Ahmadabad
GUJARAT |
9913806872
vaishu82in@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee |
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 |
Otago Exercise Program |
3 days/week for 4 weeks |
| Comparator Agent |
Square Stepping Exercise |
3 days/week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Participants willing to participate
Mini Mental State Examination more than 24
Voluntary Control Grading more than 04
Modified Ashworth Scale less than 02 |
|
| ExclusionCriteria |
| Details |
Any injury to the lower limb
Subjects with visual impairments
Any other cardiovascular or neurological disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gait parameters (gait velocity, Step length, Toe out angle) |
Before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Timed up and go test |
Before and after the intervention |
|
|
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)
|
01/10/2024 |
| 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="6"
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
|
AIM OF STUDY TO FIND OUT THE EFFECTIVENESS OF OTAGO EXERCISE PROGRAM AND SQUARE STEPPING EXERCISE ON GAIT AND BALANCE IN INDIVIDUALS WITH HEMIPARESIS
OBJECTIVE OF STUDY - TO DETERMINE THE EFECT OF OTAGO EXERCISE PROGRAM ON GAIT BY USING GAIT PARAMETERS
- TO DETERMINE THE EFECT OF OTAGO EXERCISE PROGRAM ON BALANCE BY USING TIMED UP AND GO TEST
- TO DETERMINE THE EFECT OF SQUARE STEPPING EXERCISE ON GAIT BY USING GAIT PARAMETERS
- TO DETERMINE THE EFECT OF SQUARE STEPPING EXERCISE ON BALANCE BY USING TIMED UP AND GO TEST
- TO COMPARE THE EFFECT OF OTAGO EXERCISE PROGRAM AND SQUARE STEPPING EXERCISE ON GAIT BY USING GAIT PARAMETERS
- TO COMPARE THE EFFECT OF OTAGO EXERCISE PROGRAM AND SQUARE STEPPING EXERCISE ON BALANCE BY USING TIMED UP AND GO TEST
|