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

NCT05258240 | Completed DMC

• 1 other identifier: REC-FSD-00296
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Virtual Reality; Balance Training; Balance; Diabetic Peripheral Neuropathy; Randomized Control Trial

Outcome Measures

Primary Outcomes (2)

• Berg balance scale

  The Berg Balance Scale is used to objectively determine a patient's ability or inability to safely balance during a series of predetermined tasks. Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults. Berg balance scale scoring ranges from 0 to 56. The lower your score, the more at risk you are for losing your balance. In general, Berg balance scale scores are interpreted as such: 0 to 20: A person with a score in this range will likely need the assistance of a wheelchair to move around safely.

  12th Week

• Single leg standing test

  Single leg standing test used to assess static postural and balance control. ... Client must stand unassisted on one leg, timed from the time the other foot leaves the ground till when the foot touches the ground again or the arms leave the hips. Participants unable to perform the one-leg stand for at least 5 seconds are at increased risk for injurious fall.

  12th Week

Study Arms (2)

Virtual Reality

OTHER

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.

Other: Virtual Reality

Conventional Physical Therapy

OTHER

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.

Other: Conventional Physical Therapy

Interventions

Virtual Reality 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.

Virtual Reality

Conventional Physical Therapy 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.

Conventional Physical Therapy

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

Location

Study Officials

• Muhammad Kashif

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study would be single-blinded as assessor of the study would be kept blind of the treatment group to which the patient will be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: February 28, 2022
• Study Start: March 1, 2021
• Primary Completion: March 17, 2022
• Study Completion: March 25, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)