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Completed

NCT Number: NCT05282602

Wii Fit Based Exercises and Proprioceptive Exercises in Diabetic Neuropathy Patients

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.

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Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

baseline physical therapy treatment along with Wii Fit based exercises

Other

Group A performed Wii Fit based exercises for 6 weeks. Group A will be treated with Wii Fit based exercises (40 mins session, 3 days/week, Penguin slide, soccer heading, tilt table, tightrope walking)

Proprioceptive Exercises

Other

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 session start and at the end of 6th Week.

Primary outcomes

  1. Berg Balance Scale

    Time frame: 6th Week

    Determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. A score of 56 indicates functional balance. A score of < 45 indicates individuals may be at greater risk of falling.

  2. STAR Excursion test

    Time frame: 6th Week

    Functional screening tool to assess lower extremity dynamic stability and neuromuscular control

  3. Modified Fall Efficacy scale

    Time frame: 6th Week

    Assess an individual's confidence in performing common activities of daily living without falling.5=fairly confident/fairly sure, and 10=completely confident/ completely sure. Scores can fall in between 0, 5, and 10. Interpretation: Higher scores reflect more confidence, less fear of falling. Lower scores reflect less confidence and more fear of falling

  4. Timed Up and Go Test

    Time frame: 6th Week

    Assess a person's mobility and requires both static and dynamic balance

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Wii Fit Based Exercises and Proprioceptive Training on Balance and Fall Risk in Patients With Diabetic Neuropathy

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Mar 16, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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