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Completed

NCT Number: NCT05258240

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ripah International University

Faisalabad, Punjab Province, 38000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Berg balance scale

    Time frame: 12th Week

    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.

  2. Single leg standing test

    Time frame: 12th Week

    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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

A Randomized Controlled Trial On The Effects Of Virtual Reality-Based Balance Training On Balance In Patients With Diabetic Peripheral Neuropathy

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2022
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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