| CTRI Number |
CTRI/2024/02/063247 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness of balance training with balance equipment among elderly population |
|
Scientific Title of Study
|
Effectiveness of balance training with balance postural sway system among elderly 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 |
V vignesh |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra institute of higher education and research |
| Address |
Department of Physiotherapy Outpatient unit
1- Sri Ramachandra nagar porur chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
8248171709 |
| Fax |
|
| Email |
v.vignesh1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs Rajeswari |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Physiotherapy
Outpatient unit
1- Sri Ramachandra nagar porur chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswarimuthusamy2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mrs Rajeswari |
| Designation |
MPT Neurosciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of Physiotherapy
Outpatient unit
1- Sri Ramachandra nagar porur chennai 116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswarimuthusamy2021@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Sri Ramachandra institute of higher education and research
No 1 Ramachandra Nagar, Porur Chennai 116 |
|
Primary Sponsor
Modification(s)
|
| Name |
Vignesh V |
| Address |
1- sri ramachandra nagar porur chennai 116 |
| 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 Vignesh V |
Sri ramachandra hospital |
Department of physiotherapy Outpatient unit
1-sri ramachandra nagar porur chennai 116
Chennai
TAMIL NADU |
8248171709
v.vignesh1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute og Higher education and research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
elderly population |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
balance training through balance postural sway system |
balance training through balance postural sway system weekly thrice for 4 weeks.
Duration:30 mins |
| Comparator Agent |
conventional therapy exercises |
balance training exercise
Deep breathing exercise 5reps/2 sets
Neck,shoulder,elbow,hip,knee and ankle range of motion exercises 10reps/set
Forwards and sidewards walking 10steps/2sets
Single leg standing 10counts/2sets
Sit to stand 10 reps/2sets
Multiple reaches in sitting and standing 10counts/2sets
Back leg raises with support 10counts/2sets
Side leg raises with support 10counts/2sets
Partial squatting with support 10counts/2sets
Tandem walking 10steps/2sets
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Above 60 years who can comprehend to commands
Both the genders
More than 20 score on FES-I questionnaire (moderate risk of fall)
Corrected visual and auditory problems |
|
| ExclusionCriteria |
| Details |
Associated Neurological conditions or musculoskeletal diagnosis that accounts for possible imbalance |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce Postural sway and improve center of pressure |
weekly thrice for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduce the fear of fall |
weekly thrice for 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="54" |
Phase of Trial
Modification(s)
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
02/03/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Though conventional exercises have been proved to show improvement in balance, elderly population are less cooperative as they are less interesting and engaging in conventional exercises. Balance Postural Sway System with force sensors, which reduce postural sway and improve balance with game based activity which could be interesting and focused for elderly population. This study aims to analyze efficacy of balance training with Balance Postural Sway system among elderly population. |