| CTRI Number |
CTRI/2024/10/074588 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
27/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to see effect of balance training program on balance and functional mobility in people with chronic stroke or paralysis |
|
Scientific Title of Study
|
Effect of 4- week balance training program on balance and functional mobility in individuals with chronic stroke- A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ram Priyakumari Ganesh |
| Designation |
Pg student |
| Affiliation |
SS Agrawal institute of physiotherapy and medical care education |
| Address |
Neuro outpatient department ground floor SS agrawal insititute of physiotherapy Agrawal college campus viranjali marg devina park navsari
Navsari
GUJARAT
396445
India |
| Phone |
8469905227 |
| Fax |
|
| Email |
priyarajchandrawanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jagruti Patel |
| Designation |
Associate professor, PG guide and phd scholar |
| Affiliation |
SS Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
Neuro outpatient department ground floor SS agrawal insititute of physiotherapy Agrawal college campus viranjali marg devina park navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jagruti Patel |
| Designation |
Associate professor, PG guide and phd scholar |
| Affiliation |
SS Agrawal Institute of physiotherapy and medical care education navsari |
| Address |
Neuro outpatient department ground floor SS agrawal insititute of physiotherapy Agrawal college campus viranjali marg devina park navsari
Navsari
GUJARAT
396445
India |
| Phone |
9974661767 |
| Fax |
|
| Email |
jagukpatel57@gmail.com |
|
|
Source of Monetary or Material Support
|
| Neuro outpatient department ground floor, SS agrawal insititute of physiotherapy Agrawal college campus viranjali marg devina park, navsari |
|
|
Primary Sponsor
|
| Name |
Ram Priyakumari Ganesh |
| Address |
105, parshwadarshan apna ghar society chala vapi- 396191 |
| 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 Shelsha Vaidya |
SS Agrawal Institute of physiotherapy and medical care education navsari |
department of physiotherapy SS agrawal insititute of physiotherapy Agrawal college campus viranjali marg devina park navsari
Navsari
GUJARAT |
9427285250
drsmvaidya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee SS AGRAWAL INSTITUTE OF PHYSIOTHERAPY AND MEDICAL CARE EDUCATION |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G968||Other specified disorders of central nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bosu ball balance training program |
Bosu ball balance training and conventional physiotherapy exercise program for 45-60 min for 5 days a week for 4 week |
| Intervention |
Conventional physiotherapy program |
Conventional protocol
Stretching
Strengthening
Gait training
Rom exercise for 45-60 min for 5 days a week for 4 weeks
|
| Comparator Agent |
Not applicable |
Nil |
| Intervention |
Wobble board balance training program |
Wobble board balance training and conventional physiotherapy exercise for for 45-60 min a session for 5 days a week for 4 week |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Stroke diagnosed with CT/MRI reports or ascertained by qualified medical professionals
6 months post stroke
Belonging to any gender with age 40 to 70 years
Ability to walk independently for 10 meters without assistance
Brunnstrom’s recovery stage 3 or above
Those who understood verbal instructions and had a Mini-Mental State Exam score of ≥24 were included
|
|
| ExclusionCriteria |
| Details |
Visual or vestibular deficits
No pre-existing functional limitations of lower limb
High risk of cardiac problem
Recent surgery of lower limb
Neurological diseases affecting balance other than a stroke
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Berg balance Scale and Time Up and Go Test |
Baseline and 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not taken |
Not taken |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
10/10/2024 |
| 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="1"
Months="0"
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
|
AIMS AND OBJECTIVES
•
To determine the effect of Wobble Board
Balance training program on balance and functional mobility in individuals with
the chronic stroke.
•
To determine the effect of Bosu Ball
Balance training program on balance and functional mobility in individuals with
the chronic stroke.
•
To compare the effect of Wobble Board and
Bosu Ball balance training program on balance and functional mobility with
Chronic Stroke. |