Clinical trial NCT06740227: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fear of Fall
timeFrame: 6 weeks
measure: Balance
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References: