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

Diabetic Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05258240
• Other study ID #: REC-FSD-00296
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: June 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 25, 2022
• Est. primary completion date: March 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Peripheral Neuropathy
• Peripheral Nervous System Diseases

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	Ripah International University	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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