| CTRI Number |
CTRI/2023/03/050794 [Registered on: 17/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/03/2023 |
| 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
|
Comparing effects of balance exercise versus gaze stability exercise on balance in elderly with fall risk |
|
Scientific Title of Study
|
Comparison of balance exercises and gaze stability exercises on postural and balance measures in elderly with risk of fall |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Majumi M Noohu |
| Designation |
Associate Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
105, Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia
Islamia, New Delhi,India.
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Majumi M Noohu |
| Designation |
Associate Professor |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia
Islamia, New Delhi,India
South
DELHI
110025
India |
| Phone |
9868023378 |
| Fax |
|
| Email |
mnoohu@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Arshi Firoz |
| Designation |
Post graduate student |
| Affiliation |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia
Islamia, New Delhi,India
South
DELHI
110025
India |
| Phone |
9560513338 |
| Fax |
|
| Email |
arshifiroz1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi-110025 |
|
|
Primary Sponsor
|
| Name |
Centre for Physiotherapy and Rehabilitation Sciences |
| Address |
Jamia Millia Islamia, New Delhi-110025 |
| Type of Sponsor |
Other [Central University] |
|
|
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 Majumi M Noohu |
Jamia Millia Islamia |
Room no 2, Ground
floor, PhD laboratory,
Centre for
Physiotherapy and
Rehabilitation Sciences,
Jamia Millia Islamia
South
DELHI |
9868023378
mnoohu@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly with risk of fall |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Balance Exercise |
Subjects will do balance exercises 2 times a week for 8 weeks |
| Comparator Agent |
Control Group |
Data will be taken from subjects then again after 8 weeks. No intervention is given, only lifestyle modification is taught. |
| Comparator Agent |
Gaze Stability Exercise |
Subjects will do gaze stability exercises 4 times a week for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Should not be participating in any other similar exercise program
People with poor balance (BBS score <40)
People with risk of fall (FRAT score >11)
Able to walk 15m without assistive device |
|
| ExclusionCriteria |
| Details |
Functional blindness
Receiving medication for mental disorder
Having any type of prosthesis
Any bony injury like fracture
Cognitive impairment (MOCA <26)
Diagnosed vestibular impairment
Positional vertigo
Cervical spondylitis
Migraine
Non ambulatory
Any neurological disorder like neuropathy or seizures etc |
|
|
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 |
Center of pressure
Clinical Test of Sensory Interaction and Balance (CTSIB) |
Baseline
8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proprioception
Reaction time
Fear of fall |
Baseline
8th week |
|
|
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)
|
21/03/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
People are more likely to have problems with balance as they get older. Common signs and symptoms of balance problems include: sense of motion or spinning (vertigo), feeling of faintness or light headedness (presyncope), loss of balance or unsteadiness, falling or feeling like you might fall, feeling a floating sensation or dizziness, vision changes, such as blurriness, and confusion. Falls in elderly can cause major musculoskeletal problems thus it is important to know the most effective protocol for fall prevention. Proper rehabilitation must be given to these patients as to avoid recurrence of fall. This study is needed to find which form of exercise is more effective, i.e. balance exercise or gaze stability exercise. |