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

Foundation University Islamabad

Status: Completed

Conditions: Balance; Fall Risk; Diabetic Peripheral Neuropathy

Treatments: Procedure: Virtual Reality-Based Balance Training; Procedure: Conventional Balance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06740227

FUI/CTR/2024/59

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control Group

Active Comparator group

Description:

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

Treatment:

Procedure: Conventional Balance Training

Experimental group

Experimental group

Description:

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.

Treatment:

Procedure: Virtual Reality-Based Balance Training