Effects of Virtual Reality-Based Balance Training Compared to Conventional Balance Training to Reduce Risk of Fall in Patients With Diabetic Peripheral Neuropathy: A Randomized Control Trial

The objective of this study is to determine the effects of virtual reality based balance training compared to conventional balance training to reduce risk of fall in patients with diabetic peripheral neuropathy in terms of fall and gait parameters.

The study is a non-blinded randomized control trial, consisting of 2 groups. The Study will be conducted at Fauji Foundation Hospital and Foundation University Islamabad. A calculated sample of 30 subjects will be selected via non-probability convenience sampling technique followed by randomization into two groups using envelope method.

After CBRC registration, ethical approval is obtained from ERC FUMC. Individuals fulfilling the inclusion criteria is selected, followed by written informed consent after explaining the study purpose.

Participants is then be randomly allocated to one of the 2 groups. At the baseline, Fall Efficacy Scale (FES), Activity-specific Balance Confidence (ABC), Time Up and Go Test and Dynamic Gait Index (DGI) are assessed.

Control group is provided with conventional balance training. Treatment group is provided with the Virtual Reality (Wii Fit) Based Balance Training.

Exercise training is performed thrice a week on alternate days for a total duration of 18 sessions over 06 week.

All outcome measurements would be performed before and then after the 6-weeks intervention period.

Data will be entered and analyzed on SPSS v. 22.

Study Overview

• Status: Completed
• Conditions: Diabetic Peripheral Neuropathy; Balance; Fall Risk
• Intervention / Treatment: Procedure: Conventional Balance Training; Procedure: Virtual Reality-Based Balance Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Islamabad, Punjab, Pakistan, 44000
      • Foundation University College of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age: 40 years and above
• Medical Diagnosis of diabetes under regular medication control and Diabetic Peripheral Neuropathy (DPN) confirmed
• Independent community ambulatory individuals
• Intact cognition (MMSE > 24)

Exclusion Criteria:

• Other neurological conditions I.e. Dementia, Parkinson Disease, Spinal Cord Injury or Stroke.
• Severe visual impairment, Musculoskeletal disorders, Unhealed plantar ulceration, Lower limb amputation, poor cardiopulmonary function or other disease that affects walking ability or any other disease due to which individuals are unable to walk without assistance.
• Any other condition associated with high risk of fall.
• Inability to follow simple instructions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; Conventional Balance Training one minute of rest for every five minutes of exercise Conventional Balance workout session will be for about 30-40 minutes Warm-up for 5 minutes For Static Balance, Static Balance, Single Leg Standing, Stork Standing will be used For Dynamic Balance, Weight Shifts, Tandem Walk, Single Leg Balance with Arm Movements 5 minutes will be given for cool down	Procedure: Conventional Balance Training; one minute of rest for every five minutes of exercise Conventional Balance workout session will be for about 30-40 minutes Warm-up for 5 minutes For Static Balance, Static Balance, Single Leg Standing, Stork Standing will be used For Dynamic Balance, Weight Shifts, Tandem Walk, Single Leg Balance with Arm Movements 5 minutes will be given for cool down
Experimental: Experimental group; Virtual Reality based balance training Virtual reality workout session will be for about 30-40 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For Static Balance, Lotus Focus, Tree pose, Warrior Pose games will be used For Dynamic Balance, Soccer Heading, Ski Jump, Tight Rope Walk, Table Tilt, Ski Slalom games will be used 5 minutes will be given for cool down.	Procedure: Virtual Reality-Based Balance Training; Virtual reality workout session will be for about 30-40 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For Static Balance, Lotus Focus, Tree pose, Warrior Pose games will be used For Dynamic Balance, Soccer Heading, Ski Jump, Tight Rope Walk, Table Tilt, Ski Slalom games will be used 5 minutes will be given for cool down.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fear of Fall	It is a Fall Efficacy Scale (FES) is a self-revealed measure fear of fall. The FES comprises of 10 things, each addressing a typical action of day to day living, like cleaning, dressing, or walking. Respondents rate their certainty for every movement on a 10-point Likert scale, where 1 specifies "not confident at all" and 10 implies "completely confident." The all out score, got by adding the appraisals across all things, goes from 10 (least certainty) to 100 (most noteworthy certainty).	6 weeks
Balance	Activity Specific Balance Confidence (ABC) Scale is used particularly in assessing balance confidence among individuals, especially older adults, who may have concerns about falling during daily activities.	6 weeks

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Motor Neuron Disease; Hyperglycemia; Metabolic Disease; Neuropathic Pain; Peripheral Nervous System Disease; Balance Rehabilitation; Diabetic Peripheral Neuropathy (DPN); Hyperglycemia-Induced Neuropathy; Sensory Disorder; Blood Glucose Regulation Disorders; Small Fiber Neuropathy,; Virtual Reality Based Balance Training; Conventional Balance Training; Fall prevention Intervention
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nervous System Diseases; Neuromuscular Diseases; Diabetes Mellitus; Diabetes Complications; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: FUI/CTR/2024/59

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No