Clinical trial NCT05282602: Wii Fit Based Exercises and Proprioceptive Exercises in Diabetic Neuropathy Patients
Official title: Effects of Wii Fit Based Exercises and Proprioceptive Training on Balance and Fall Risk in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Wii Fit
Proprioceptive
Fall
Balance
Diabetic Neuropathy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is a Randomized clinical trial that will be conducted to check the effects of Wii Fit Based Exercises and Proprioceptive training on Balance and Fall Risk in patients with Diabetic Neuropathy, duration of study will be of 6months, convenient sampling will be used, subject following eligibility criteria from Riphah Rehabilitation Centre, Patients will be randomly allocated into two groups; Group A will be treated with Wii Fit based exercises (40 mins session, 3 days/week, Penguin slide, soccer heading, tilt table, tightrope walking) \& Group B will be treated with Proprioceptive training (40 min session, 3 days/week, toe walking, heel walking, cross-body leg swings right and left sides, partial squat, ). In both groups pre and post-test measurements of Balance and Fall of risk will be assessed through Berg Balance scale, STAR excursion, Modified Fall Efficacy scale, and Timed Up and Go (TUG). Evaluation will be done before the session start and at the end of 6th Week.

Detailed description: Diabetes mellitus is a disorder in which the body does not produce enough or respond normally to insulin, causing blood sugar (glucose) levels to be abnormally high. Diabetic neuropathy is a serious diabetes complication that may affect as many as 50% of people with diabetes. The nerve damage associated with diabetic peripheral neuropathy (DPN) may reduce the proprioceptive inputs that contribute to decreased balance and an increased risk of falling. Wii Fit Balance Board improves balance in older adults through training. Wii Fit balance board showed significant improvement in balance and decrease the risk of fall. Proprioceptive training is an intervention that targets the improvement of proprioceptive function in patients. The aim of the current study is to determine the effects of Wii Fit Based exercises and proprioception training on balance and fall of risk in patients with Diabetic Neuropathy

Eligibility criteria: Inclusion Criteria:

* 40-80 years of age;
* Medical diagnoses of diabetes under regular medication control
* DN4 score ≥ 4
* Independent community ambulatory individuals;
* Intact cognition (Minimental State Examination score of \>24

Exclusion Criteria:

* Other neurological diseases such as dementia, Parkinson's disease, spinal cord injury, or stroke;
* Severe visual impairment, musculoskeletal disorders, unhealed plantar ulceration, lower limb amputation, poor cardiopulmonary function, or other diseases affecting walking ability or any other disease due to which individuals were unable to walk without assistance
* Any other condition associated with a high risk of falling

Primary outcomes:
measure: Berg Balance Scale
timeFrame: 6th Week
measure: STAR Excursion test
timeFrame: 6th Week
measure: Modified Fall Efficacy scale
timeFrame: 6th Week
measure: Timed Up and Go Test
timeFrame: 6th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Syed Shakil Ur Rehman, PhD
role: STUDY_CHAIR
affiliation: Riphah International University
name: Maryam Ikram, MSPT(NM)*
role: PRINCIPAL_INVESTIGATOR
References:
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