Wii Fit Based Exercises and Proprioceptive Exercises in Diabetic Neuropathy Patients

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05282602

Collaborator

(none)

Enrollment

Location

Arms

6.3

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Neuropathies	Other: baseline physical therapy treatment along with Wii Fit based exercises Other: Proprioceptive exercises	N/A

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 20, 2022

Anticipated Primary Completion Date :

Jul 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Wii Fit Based Exercises Group A will receive Wii fit Based Exercises	Other: baseline physical therapy treatment along with Wii Fit based exercises 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)
Experimental: Proprioceptive Training Group B will receive proprioceptive training	Other: Proprioceptive exercises 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.

Arm

Intervention/Treatment

Experimental: Wii Fit Based Exercises

Group A will receive Wii fit Based Exercises

Other: baseline physical therapy treatment along with Wii Fit based exercises

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)

Experimental: Proprioceptive Training

Group B will receive proprioceptive training

Other: Proprioceptive exercises

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.

Outcome Measures

Primary Outcome Measures

Berg Balance Scale [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.
STAR Excursion test [6th Week]
Functional screening tool to assess lower extremity dynamic stability and neuromuscular control
Modified Fall Efficacy scale [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
Timed Up and Go Test [6th Week]
Assess a person's mobility and requires both static and dynamic balance

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riphah Rehabilitation Center	Lahore	Punjab	Pakistan	54000

Sponsors and Collaborators

Riphah International University

Investigators

Study Chair: Syed Shakil Ur Rehman, PhD, Riphah International University
Principal Investigator: Maryam Ikram, MSPT(NM)*, Riphah International University