Clinical trial NCT05258240: Effects of Virtual Reality-based Balance Training on Balance of Diabetic Peripheral Neuropathy Patients
Official title: A Randomized Controlled Trial On The Effects Of Virtual Reality-Based Balance Training On Balance In Patients With Diabetic Peripheral Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Peripheral Neuropathy
Keywords: Virtual Reality
Balance Training
Balance
Diabetic Peripheral Neuropathy
Randomized Control Trial
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 60
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aimed to clarify the effect of virtual reality-based balance training on balance in patients with diabetic peripheral neuropathy compared to conventional physical therapy.

Detailed description: A randomized control trial will be conducted at the study setting Safi Hospital Faisalabad after the approval of the synopsis. The study will be a single-blinded randomized control study. A convenient sampling technique will be used for the enrollment of the patient. Patient selection will be done based on defined insertion and omission criteria.

Two groups would be made, the intervention group would receive the virtual gaming exercise tutoring and the control group would receive the regular physiotherapy exercises.

The evaluation of the patients will be done at the start of the study, after six weeks, and after twelve weeks. Follow-up will be in the 16th weeks after the cessation of therapy.

The patient's outcome will be measured on Berg Balance Scale and the Single Leg Stance test and the patient's data will be recorded before and after treatment, comparisons between before the treatment and after the treatment data will be made after 12 weeks. Informed consent/approval would be taken from each patient. Analysis and entry of data will be done by Statistical Package of Social Sciences Version 22 Software.

Eligibility criteria: Inclusion Criteria:

* Adults age (45-65 years)
* Male and female (both gender)
* Medical diagnoses of type-II diabetes
* DPN confirmed by physician
* Stages ( Ia - sign but no symptoms of neuropathy, Ib - symptomatic mild diabetic poly neuropathy, sensory, motor or autonomic symptoms; patient able to heel walk)
* Patients independent in transfer.
* Unimpaired cognition/intelligence (Mini Mental State Examination Score of \>24)

Exclusion Criteria:

* Any neurological diseases e.g. Dementia, Parkinson, Stroke
* Severe visual impairment and Cardiopulmonary disease
* Musculoskeletal disorder, any disease due to individual were unable to walk and lower limb amputation
* Disease which has chances of falling

Primary outcomes:
measure: Berg balance scale
timeFrame: 12th Week
measure: Single leg standing test
timeFrame: 12th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References: