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
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- KLE ACADEMY OF HIGHER EDUCATION AND RESEARCH
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- 5 times sit to stand, timed up and go test, s-lanss pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy
Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Other
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 40.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Willingness to participate, Adults with type II diabetes mellitus diagnosed with diabetic neuropathy, Independent community ambulation, intact cognition.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
5 times sit to stand, timed up and go test, s-lanss pain score, Diabetic neuropathy symptom scale, Norfolk Quality of Life-Diabetic Neuropathy
Time Frame: Baseline and 4 week after intervention.
Secondary Outcomes
No secondary outcomes reported
Investigators
Aakanksha Gujar
KAHER Institute of Physiotherapy