| CTRI Number |
CTRI/2024/06/068414 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Whole Body Vibration vs. Focal Vibration with Conventional Exercises on Older Adult Balance |
|
Scientific Title of Study
|
Added Effect of Whole Body Vibration versus Focal Vibration along with Conventional Exercises on Balance in Older Adults |
| 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 Madhuri Rajbhar |
| Designation |
PG Student |
| Affiliation |
MAEERs College of Physiotherapy, Talegaon Dabhade |
| Address |
A-230 Neurophysiotherapy Department 2nd floor OPD Building MAEERs College of Physiotherapy Near Talegaon Railway Station Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
02114308391 |
| Fax |
|
| Email |
rajbharmadhuri1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priya Chitre |
| Designation |
Associate Professor |
| Affiliation |
MAEERs College of Physiotherapy, Talegaon Dabhade |
| Address |
A-230 Neurophysiotherapy Department 2nd floor OPD Building MAEERs College of Physiotherapy Near Talegaon Railway Station Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
02114308391 |
| Fax |
|
| Email |
priyachitre@mitmimer.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sumitra Sakhawalkar |
| Designation |
Associate Professor |
| Affiliation |
MAEERs College of Physiotherapy, Talegaon Dabhade |
| Address |
A-230 Neurophysiotherapy Department 2nd floor OPD Building MAEERs College of Physiotherapy Near Talegaon Railway Station Talegaon Dabhade
Pune
MAHARASHTRA
410507
India |
| Phone |
02114308391 |
| Fax |
|
| Email |
sumitra26@mitmimer.com |
|
|
Source of Monetary or Material Support
|
| MAEERs College of Physiotherapy, Talegaon Dabhade |
|
|
Primary Sponsor
|
| Name |
MAEERs College of Physiotherapy Talegaon Dabhade |
| Address |
A-230, Neurophysiotherapy Department, 2nd floor OPD Building, MAEERs College of Physiotherapy, Near Talegaon Railway Station, Talegaon Dabhade- 410507 |
| Type of Sponsor |
Private medical college |
|
|
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 Sumitra Sakhawalkar |
MAEERs College of Physiotherapy, Talegaon Dabhade |
A 230 Neurophysiotherapy Department 2nd floor OPD Building MAEERs College of Physiotherapy Near Talegaon Railway Station Talegaon Dabhade 410507
Pune
MAHARASHTRA |
9049998861
sumitra26@mitmimer.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAEERs College of Physiotherapy Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Balance Impairment |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Focal Vibration with Conventional Exercises |
Focal vibration will be provided through hand held vibrator which is placed on the muscle belly or tendon. The head held device is placed on the Quadriceps, Tibialis
anterior and the Gastrocnemius muscle. The participant position will be in supine lying. The duration of FV will be 3 minutes bilaterally on each muscle. The frequency used here is 60-100 Hz. Focal Vibration will be given for 6 weeks and 3 days a week.
|
| Comparator Agent |
NA |
NA |
| Intervention |
Whole Body Vibration with Conventional Exercises |
Participant will be advised to stand upright on the platform,
over clearly marked foot positions, wearing normal footwear. The position of the participant should be erect with slightly knee flexed. A handrail can be used for support in case required. The duration of WBV will be 3 mins for 3 repetitions and 1
min of interval between each set. The frequency used here is 15-30 Hz. Whole Body Vibration will be given for 6 weeks and 3 days a week. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
- Young old adults with age group of 65-75 years, male or female (1, 18)
- Normal general cognition (MMSE ≥ 24)
- Mild to moderate risk of fall
- Able to walk 10m independently with or without use of assistive device. |
|
| ExclusionCriteria |
| Details |
- High risk of fall (BBS ≤ 20).
- Any musculoskeletal injury, pain or deformity in the lower limb; acute upper limb conditions
- Any cardiac conditions or neurological conditions affecting balance.
- Presence of uncontrolled Hypertension and Diabetes.
- Presence of Vestibular dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| POMA (Performance Oriented Mobility Assessment) |
6 Weeks |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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/ Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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 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
|
Background: As the part of the aging process older adults show decline in various physiological systems of the body. The age related decline in Nervous system cause anatomical changes in the brain which result in neuronal loss. Pacinian corpuscles, which sense the vibratory stimuli, decrease in density with advancing age. This results in balance impairment, loss of muscle strength, muscle endurance and power, loss of mobility, cognitive decline, decrease aerobic capacity, decline in visual acuity, decrease touch sensation and vestibular dysfunction. Therefore, improving balance and thereby enhancing the quality of life in older adults forms an integral part of a rehabilitation program. The Conventional exercise program mainly focuses on the muscle strength, power, endurance and flexibility for balance improvement in older adults. The WBV training is one in which mechanical vibrations are transmitted from the feet to the rest of the body using a vibrating platform for 3 min with 1 min of interval between each repetition for 3 repetitions. Focal Vibration is a hand held device or wearable device which uses frequency of 100 Hz. The effective time required for focal vibration to have an effect is 40s to 3 min bilaterally on each muscle. 3 major muscles of the lower limb are targeted– Quadriceps, Tibialis Anterior and Gastrocnemius which thereby helps in improving balance. So the purpose of this study is to compare WBV with FV and to assess which exercise program is more effective in improving balance in older adults. Material and Methods: In this study 40 participants will be selected according to inclusion and exclusion criteria. With purposive sampling participants will be divided into two groups, Group A and Group B. Group A will be given WBV along with conventional exercise 3 times a week for 6 weeks. Group B will be given FV along with conventional exercise 3 times a week for 6 weeks. Pre and Post intervention assessment of static balance will be taken by Functional Reach Test and dynamic balance by using POMA scale. |