| CTRI Number |
CTRI/2023/10/059314 [Registered on: 30/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Cluster Randomized Trial |
|
Public Title of Study
|
Feedback exercises to improve balance in young old geriatric population. |
|
Scientific Title of Study
|
Role of EMG (Electromyographic) Biofeedback on Ankle to improve balance in young old geriatric population. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aishwarya Valiv |
| Designation |
MPT student |
| Affiliation |
sunandan divatia school of sciences |
| Address |
Department of Physiotherapy ground floor, Nanavati Super Speciality Hospital, SV road, Vile parle West Mumbai 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9867475967 |
| Fax |
|
| Email |
aishwaryasvaliv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sabah Thaver |
| Designation |
Assistant Professor- Physiotherapist |
| Affiliation |
Sunandan Divatia school of science |
| Address |
Dept of physiotherapy, Cabin no 755, 7th Floor Sunandan divatia school of science, Mithibai building, Vile Parle west, mumbai 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9820691076 |
| Fax |
|
| Email |
Sabah.Thaver@nmims.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sabah Thaver |
| Designation |
Assistant Professor- Physiotherapist |
| Affiliation |
Sunandan Divatia school of science |
| Address |
Dept of physiotherapy, Cabin no 755, 7th Floor Sunandan divatia school of science, Mithibai building, Vile Parle west, mumbai 400056
Mumbai (Suburban)
MAHARASHTRA
400056
India |
| Phone |
9820691076 |
| Fax |
|
| Email |
Sabah.Thaver@nmims.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Nanavati Max Super Specialty Hospital, Vile parle West |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
nil |
| Type of Sponsor |
Other [NIL] |
|
|
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 Ali Irani |
Nanavati Max Super Speciality Hospital |
Department of physiotherapy ground floor, Nanavati Max Super Speciality hospital, Vile Parle West, Mumbai 400056
Mumbai (Suburban)
MAHARASHTRA |
02226172329
physiodept.nanavati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee Dr. Balabhai Nanavati Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Geriatric population age: 65-75 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - EMG Biofeedback |
EMG Biofeedback training will be given for gastrocnemius and tibialis anterior muscles,for 10 sessions, alternate days |
| Intervention |
Group B - EMG Biofeedback and Balance exercises |
In addition to EMG biofeedback, balance exercises will be given which will include foam surface, blocking of vision, for 10 sessions alternate days |
| Comparator Agent |
Group C - Balance exercises |
Each balance exercise will be done 10 repetitions 1 set. Foam surface will be added in 4th session and blocking of vision on 8th session onwards. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
geriatric population |
|
| ExclusionCriteria |
| Details |
Any known musculoskeletal/neurological condition which may hamper balance.
Any systemic illness that may hamper balance.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
MiniBEST
Functional Reach test
Balance master |
Baseline and post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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 2 |
|
Date of First Enrollment (India)
|
30/10/2023 |
| 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="6"
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
|
Title - Role of EMG (Electromyographic) Biofeedback on Ankle to improve balance in young old geriatric population. Introduction - Approximately 30% of the older population falls once in a year. WHO addresses this situation as a public health issue because falls lead to injuries and fractures which may involve the combination of hospitalisation and resulting costs. Literature indicates that falls are caused by factors classified as extrinsic and intrinsic. Extrinsic factors are related to infrastructure features of the environment, including circumstantial aspects of flooring and lighting. Intrinsic factors, in turn are associated with physiological changes affecting the human body as a result of aging process. The most commonly used resource employed for postural adjustment is the Ankle Strategy. Ankle strategy is called the ankle sway and uses length of the foot as a lever to correct for minor losses of balance. EMG biofeedback is a technique that teaches people how to control otherwise involuntary or unfelt events by adjusting the displayed signals. Exercise programmes using EMG biofeedback are recommended because they boost patients motivation and exercise compliance. Muscle strength of ankle dorsiflexion, plantar flexion, inversion and eversion have been shown to decline with aging, thereby showing a decline in the ability to use ankle strategy. There is a need to retrain the elderly to be able to use their ankle strategies more efficiently with the help of exercises. Therefore this study aims at studying the role of EMG biofeedback as an adjunct to a standardised balance program to see the added benefits of the former.
Aim - To assess the role of EMG biofeedback on ankle to improve balance in young old geriatric population.
Objective - To assess the effect of EMG biofeedback on ankle to improve balance in young old geriatric. To assess the effect of EMG biofeedback in adjunct to a standardised exercise protocol on ankle to improve balance in young old geriatric population To assess the effect of a standardised exercise protocol on ankle to improve balance in geriatrics To compare the results of the three groups.
Inclusion criteria - Geriatric population with age 65 to 75 years
Exclusion criteria - Any known musculoskeletal/neurological condition which may hamper balance. Any systemic illness that may hamper balance.
Outcome measures - MiniBEST, Functional Reach test, Balance Master
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