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

NCT06740227 | Completed

• 1 other identifier: FUI/CTR/2024/59
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Peripheral Neuropathy; Balance; Fall Risk

Keywords

Diabetic Peripheral Neuropathy (DPN); Peripheral Nervous System Disease; Hyperglycemia-Induced Neuropathy; Neuropathic Pain; Sensory Disorder; Motor Neuron Disease; Metabolic Disease; Blood Glucose Regulation Disorders; Hyperglycemia; Small Fiber Neuropathy,; Virtual Reality Based Balance Training; Conventional Balance Training; Balance Rehabilitation; Fall prevention Intervention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Experimental group

EXPERIMENTAL

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

Interventions

Virtual Reality-Based Balance Training PROCEDURE

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.

Experimental group

Conventional Balance Training PROCEDURE

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

Control Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, Punjab Province, 44000, Pakistan

Location

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuralgia; Sensation Disorders; Motor Neuron Disease; Metabolic Diseases; Hyperglycemia; Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodegenerative Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: July 10, 2024
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: January 27, 2025

Record last verified: 2024-12

Locations

PA (1)