| CTRI Number |
CTRI/2024/10/074780 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
How Whole-Body Vibration and Virtual Reality Help with Balance, Pain, and Quality of Life in Diabetic Neuropathy: A Study" |
|
Scientific Title of Study
|
Comparing The Effect Of Whole Body Vibration And Virtual Reality On Balance, Pain And Quality Of Life In Diabetic Neuropathy Patients- A Randomized Controlled Trail |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aakanksha Gujar |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Building D3, block no 23, Girnar Complex, Ratanshi nagar, Sangli
Sangli
MAHARASHTRA
416416
India |
| Phone |
9359590522 |
| Fax |
|
| Email |
aakankshagujar14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aakanksha Gujar |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Building D3, block no 23, Girnar Complex, Ratanshi nagar, Sangli
Sangli
MAHARASHTRA
416416
India |
| Phone |
9359590522 |
| Fax |
|
| Email |
aakankshagujar14@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjiv Kumar |
| Designation |
Professor and Principal |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KAHER Institute of Physiotherapy,Department of Neurophysiotherapy, Nehru Nagar,Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
sanjiv3303@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr. Prabhakar Kore Hospital |
|
|
Primary Sponsor
|
| Name |
KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH |
| Address |
NEHRU NAGAR, BELGAVI |
| 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 Aakanksha Gujar |
KLEs Dr. Prabhakar Kore Hospital |
Department of Neuro physiotherapy, room no 19, Nehru nagar, Belagavi
Belgaum
KARNATAKA |
9359590522
aakankshagujar14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE Academy of Higher Education |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetic Neuropathy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Physiotherapy |
Stance on heel/toes
Tandem standing
Side walking
Backward walking
One leg stance
Marching
Sit to stand
Stairclimbing
Obstacle walking
Treadmill walking
|
| Intervention |
Virtual Reality |
Virtual reality headset is a head-mouthed device that provides virtual reality for the wearer.
Virtual reality has focal distance adjustment, device buckle, pupil distance adjustment, device body, touch screen button, lens, microphone, leather patch, volumn button.
|
| Intervention |
Whole Body Vibration |
Whole body vibration is a compact and light weight and multi benefit exercise tool which helps person reach all the body goals.
The Personal Power Plate has a set frequency of 35 Hz, a 30 or 60 seconds timer, a strap set, rubber mat, power cord, and remote control for easy operation.
Intervention can be given in sitting, standing, lying down.
Vibration energy output: low to high
Maximum load: 120 kg
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Willingness to participate, Adults with type II diabetes mellitus diagnosed with diabetic neuropathy, Independent community ambulation, intact cognition. |
|
| ExclusionCriteria |
| Details |
Other neuropathy such as GBS, leprosy, CIPN,Any other neurological condition such as dementia, stroke, Parkinson and any cardiac condition, Cancer and cancer survivors, History of vertigo and BPPV, Lower limb fracture with acute stage or deformed, Any other condition associated with high risk of fall, Kidney or bladder stones. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
5 times sit to stand, timed up and go test, s-lanss pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy
|
Baseline and 4 week after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
13/10/2024 |
| Date of Study Completion (India) |
11/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
11/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
|
India has one of the highest prevalence of type-2 diabetes mellitus (T2DM) in the world. Diabetic peripheral neuropathy (DPN) is the most common complication among DM patients. Diabetic Neuropathy detrimentally impacts an individual’s quality of life by causing balance impairments and chronic pain. Whole body vibration (WBV) is non invasive somatosensory stimulation which involves application of mechanical vibration stimulating neuromuscular pathway. It is easy to use and time efficient. Despite the growing popularity of WBV and VR intervention, there is lack of literature about comparative studies specifically focusing on diabetic neuropathy. Hence this study aims to shed light upon the comparative effect of WBV and VR in patients with diabetic neuropathy.
Aim: To compare the effect of Whole Body Vibration and Virtual reality in diabetic neuropathy patients on balance, pain and quality of life.
Objective: To compare the effect of Whole Body Vibration and Virtual reality in diabetic neuropathy patients using 5 times sit to stand and timed up and go test, S-LANSS pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy. Hypothesis Null Hypothesis: There will be no difference in effects of whole body vibration and virtual reality on balance, pain and quality of life in diabetic neuropathy patients. Alternative Hypothesis: There will be difference in effects of whole body vibration and virtual reality on balance, pain and quality of life in diabetic neuropathy patients. Source of data: Tertiary care hospitals and diabetic clinics in Belagavi city Study design: Experimental Study Study Type: Randomized clinical Trail Target population: Subject with type II diabetes mellitus diagnosed with diabetic neuropathy Duration of Study: 12 months Sample size: 36 (12 in each group) Procedure:
Prior to the commencement of the study, an Ethical Clearance will be obtained from the Institutional Ethical Committee Study will be registered in CTRI prospectively. Subjects will be briefed about the purpose of the study. Participants will be selected based on inclusion and exclusion criteria. A written inform consent will be taken from the participants in their own language and those consenting to participate in the study will be presented with the interventions. Participants will be allotted into three study groups by envelop method. Demographic data will be noted. Group A:
• Whole body vibration 3 sessions/week for 4 weeks. • Frequency of whole body vibration 30 Hz, amplitude 2 mm for 3×4 mins with 1 min of rest. • Conventional physiotherapy will be followed for next 30 mins Group B: • Virtual Reality for 3 sessions/ week for 4 weeks. • virtual reality based games for 20 mins • For the first 4 session the therapeutic protocol will be implemented using Table tilt and VR walk. • For next 4 sessions the therapeutic protocol will be implemented using Archery and supermarket VR. • For next 4 sessions the therapeutic protocol will be implemented using Rollercoaster and rope walker VR. • Conventional physiotherapy will be followed for next 30 mins. Group C:
The session will be for 45-50 mins for 3 days a week for 4 weeks. The session will include Stance on heel/toes Tandem standing Side walking Backward walking One leg stance Marching Sit to stand Stairclimbing Obstacle walking Treadmill walking
|