| CTRI Number |
CTRI/2025/05/086718 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| 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
|
Study on the Benefits of Whole-Body Vibration for Memory, Balance, and Function in Individuals with Knee Joint Problems |
|
Scientific Title of Study
|
Effect of Whole-body Vibration on cognition, dynamic balance and functional ability among chronic knee osteoarthritis individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHARANIASELVI M N |
| Designation |
MPT STUDENT |
| Affiliation |
SRM Institute of Science And Technology |
| Address |
Room No: PT 22, Fourth Floor,
SRM College of Physiotherapy,
SRM Medical College Building,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur,
Chengalpattu District, Tamil Nadu, India – 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6385500846 |
| Fax |
|
| Email |
ms8215@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
PRIYANKA B |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRM Insitute of Science and Technology |
| Address |
Experts Paradise, Fifth Floor,
SRM College of Physiotherapy,
SRM Medical College Building,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology, SRM Nagar, Potheri , Kattankulathur,
Chengalpattu District, Tamil Nadu, India – 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500116838 |
| Fax |
|
| Email |
priyankb2@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
PRIYANKA B |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Room No: PT 22, Fourth Floor,
SRM College of Physiotherapy,
SRM Medical College Building,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur,
Chengalpattu District, Tamil Nadu, India – 603203.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9500116838 |
| Fax |
|
| Email |
priyankb2@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur,
Chengalpattu District, Tamil Nadu, India – 603203. |
|
|
Primary Sponsor
|
| Name |
SHARANIASELVI M N |
| Address |
Room No: PT 22, Fourth Floor,
SRM College of Physiotherapy,
SRM Medical College Building,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology, SRM Nagar, Potheri, Kattankulathur,
Chengalpattu District, Tamil Nadu, India – 603203. |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
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 SHARANIASELVI M N |
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
C-21, FIRST FLOOR, SRM PHYSIOTHERAPY OUTPATIENT DEPARTMENT,
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, SRM NAGAR, POTHERI, KATTANKULATHUR, CHENGALAPTTU DISTRICT, TAMILNADU, INDIA,603203.
Kancheepuram
TAMIL NADU |
6385500846
ms8215@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
WHOLE BODY VIBRATION ON COGNITION ,DYNAMIC BALACE AND FUNCTIONAL ABILITY |
Whole Body Vibration Protocol: Set Whole Body Vibration machine parameters (e.g., frequency of 20-30 Hz, amplitude of 1-4 mm).
Duration: 10-15 minutes per session, beginning with lower intensity and progressively increasing as tolerated.
Position: Begin with participants standing on the platform with slight knee flexion upto 60 degree to engage leg muscles.
Exercise Program: Included exercises targeting strength, flexibility, and balance to the capabilities of knee OA patients.
Repetition and sets : 10-15reps and 3 sets |
| Comparator Agent |
WHOLE BODY VIBRATION ON COGNITION, DYNAMIC BALANCE AND FUNCTIONAL ABILITY. |
Exercise Program: Provide a similar exercise regimen as the intervention group.
Ensure both groups engage in exercises of similar intensity and duration to isolate the effect of WBV.
Quadriceps isometrics, straight leg raise, Heel and calf raises, Squats, Pelvic bridging.
Repetition and sets : 10-15reps and 3 sets |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of OA
Participants reported pain for more than 2 yrs.
Ability to engage in moderate physical activity.
MMSE score of less than or equal to 23
According to Kellgren and Lawrence grading scale grade 3 and 4 OA
Low risk of fall according to TUG test less than 12 seconds |
|
| ExclusionCriteria |
| Details |
Recent lower limb surgeries
Acute lower limb injuries
Cardiovascular condition
Neurological condition
Lower limb infection or inflammation
Implants or Pacemakers
Hypertension 140/90 mmHg. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mini-Mental State Examination
Modified star excursion balance test
WOMAC Western Ontario and McMaster Universities Osteoarthritis Index
NPRS Numeric Pain Rating Scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Range of motion
Manual muscle testing |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
26/05/2025 |
| 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
|
Participants will be selected according to the inclusion and exclusion criteria and an informed consent will be obtained. The research objectives will be explained to the participants in their regional language. Further the participants will be asked to provide details on demographic data along with MMSE assessment for cognitive screening. A sample size of 56, both men and women, with the age group of 45 years and above will be selected. The Pre- Test will be done measuring Blood pressure, Heart rate, Respiratory rate will be assessed using sphygmomanometer and smart watch. Mini-Mental State Examination (MMSE) to assess cognition, Modified star excursion balance test to assess dynamic balance, Numeric Pain Rating Scale to assess pain WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) to assess pain, stiffness and physical function related to knee will be assessed. The intervention group A will be treated with whole body vibrator for 3 sessions per week and strengthening exercise for 5 session per week for 4 weeks. The control Group B will be treated with strengthening exercise for 5 sessions per week for 4 weeks. Along with this conventional treatment protocol for OA patients will be followed. After the intervention at the end of 4th week the post test will be done by reassessing with same outcome measures. The obtained scores will be statistically analysed to find effect of whole body vibrator on cognition, dynamic balance and functional ability among chronic knee OA individuals. |