| CTRI Number |
CTRI/2024/01/061736 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/01/2024 |
| 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
|
To examine how vibration therapy helps older adults in improving balance and moving better: A Dosimetry study |
|
Scientific Title of Study
|
Effect of whole body vibration training on balance and mobility in older adults: A dosimetry study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aqsa Mujaddadi |
| Designation |
Assistant professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia,room no. 103
New Delhi (110025)
South
DELHI
110025
India |
| Phone |
8130676908 |
| Fax |
|
| Email |
aqsamuj786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aqsa Mujaddadi |
| Designation |
Assistant professor |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia,room no. 103
New Delhi (110025)
South
DELHI
110025
India |
| Phone |
8130676908 |
| Fax |
|
| Email |
aqsamuj786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Md Asif |
| Designation |
Post graduate student, MPT |
| Affiliation |
Jamia Millia Islamia |
| Address |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi
South
DELHI
110025
India |
| Phone |
9582868941 |
| Fax |
|
| Email |
amansooriasif786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia University |
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Maulana Mohammad Ali Jauhar Marg Jamia Nagar Okhla 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 Aqsa Mujaddadi |
Centre for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia |
Room no. 8, Ground floor, OPD Centre for Physiotherapy and Rehabilitation Sciences clinic, Jamia Millia Islamia, Maulana Mohammad Ali Jauhar Marg, Okhla, New Delhi - 110025
South
DELHI
South
DELHI |
8130676908
aqsamuj786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Jamia Millia Islamia |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy older adults with mild to moderate balance impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
whole body vibration (long duration) |
Healthy older adults with mild-to-moderate balance impairment undergo 20 bouts of 1 minute after subsequent 1 minute rest.
Subject are allowed to stand on vibrating platform at frequency of 30Hz, 35Hz and 40Hz with their knees flexed and their arms supported |
| Comparator Agent |
whole body vibration (moderate duration) |
Healthy older adults with mild-to-moderate balance impairment undergo 8 bouts of 1 minute after subsequent 1 minute rest.Subject are allowed to stand on vibrating platform at frequency of 30Hz, 35Hz and 40Hz with their knees flexed and their arms supported.
|
| Intervention |
whole body vibration (short duration) |
Healthy older adults with mild-to-moderate balance impairment undergo 4 bouts of 15 seconds after subsequent 1 minute rest.Subject are allowed to stand on vibrating platform at frequency of 30Hz, 35Hz and 40Hz with their knees flexed and their arms supported. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Elderly (aged 60 years and above)
Ability to understand verbal commands
Ability to walk 10m
Subjects with adequate cognitive health (MMSE score 20 or more )(Folestein et al., 1975)
Subjects with mild to moderate fall risk according to Falls efficacy scale (score 13/28) (Khajavi 2013)
|
|
| ExclusionCriteria |
| Details |
Recent fractures(<6 months)
Metal implant in lower extremity
Joint inflammation(osteoarthritis and rheumatoid arthritis)
Deep vein thrombosis
Severe osteoporosis
Epileptic individuals
Acute cardiovascular conditions
(Tomas et. al., 2011) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Berg Balance Scale: used to assess balance.
2. Tinetti Poma Scale: used to assess balance and mobility.
3. Time Up and Go Test (TUG): used to assess mobility
4. Functional reach test: used to assess balance
5. Stair climb test: used to assess mobility. |
Baseline at the 1st week before the commencement of trial.
At the 6th week post-intervention assessment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Stair climb test - Use to assess mobility. |
Baseline at the 1st week before the commencement of trial.
At the 6th week post-intervention assessment |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 1 |
|
Date of First Enrollment (India)
|
25/01/2024 |
| 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: To investigate the efficacy of WBV on balance and mobility in older adults through a dosimetry study. By systematically varying the dosimetry parameters, we will evaluate the impact of different WBV protocols on balance and mobility outcomes in older adults.The significance of this research lies in its potential to enhance balance and mobility, contribute to non-pharmacological interventions, address dosimetry considerations, prevent falls, and promote evidence-based practice. Methodology: It will be a prospective dosimetry study, including the elderly (60 years of age and older, both males and females). The participants will be screened for having a minimum to moderate risk of falls using a short Falls Efficacy Scale and Mini-mental Status Examination.Results will be reported for all the outcome measures at baseline and post-intervention at 6th week from baseline. |