Effects of Virtual Reality-based Balance Training on Balance of Diabetic Peripheral Neuropathy Patients

NCT ID: NCT05258240

Last Updated: 2022-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-03-25

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.

Conditions

Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality

Virtual reality workout session will be for about 50 minutes in which warm-up exercise will be for 5 minutes including relaxed breathing, selected exercises for dynamic balance and static balance will take 40 minutes of the session in which games; tilt city, soccer heading, table tilt game, and penguin tilt will be used for dynamic balance training. For static balance training games will be torso leg curl and single leg extension. After that 5 minutes will be given for cools down.

Group Type: OTHER

Virtual Reality

Intervention Type: OTHER

Virtual reality workout enhances balance control, self-reported balance and mental stability in healthy and stable adults. Sensory-based exercise and the response to visual acuity can increase the patient's ability to maintain their body in a stable position.

Conventional Physical Therapy

Conventional physical therapy will be provided to this group for 50 minutes, with one minute of rest for every five minutes of exercise. Warm-up for 5 minutes, balancing-drills for 40 minutes, and cools down for five minutes. The session will include; slow and deep breathing exercise for about 3 minutes, patient will be asked to move both ankle joint to its complete range of movement for about five minutes, posture training for balance includes standing from sitting for five times, shifting the weight of the body while standing at one place for five times, move the body to the side and forward to aim the objective set by the therapist for five times, lift or raise the heels for five times of both foot for 20 seconds for each rise, to stand on one foot for 15 seconds, five times, to stand on one foot and bend the knee for about 15 seconds, five times. Wobble board preparation gait training and spot marching will be performed for about 5 to 6 minutes each.

Group Type: OTHER

Conventional Physical Therapy

Intervention Type: OTHER

Postural training, standing, walking, and walking activities are included in the conventional physical therapy in domain of balance exercise training programs. These activities are usually boring and tedious because these exercises are repeated many times.

Interventions

Virtual Reality

Virtual reality workout enhances balance control, self-reported balance and mental stability in healthy and stable adults. Sensory-based exercise and the response to visual acuity can increase the patient's ability to maintain their body in a stable position.

Intervention Type: OTHER

Conventional Physical Therapy

Postural training, standing, walking, and walking activities are included in the conventional physical therapy in domain of balance exercise training programs. These activities are usually boring and tedious because these exercises are repeated many times.

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Muhammad Kashif

Role: STUDY_CHAIR

Riphah International University

Locations

Ripah International University

Faisalabad, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

REC-FSD-00296

Identifier Type: -

Identifier Source: org_study_id