Wii Fit Based Exercises and Proprioceptive Exercises in Diabetic Neuropathy Patients

Diabetic Neuropathies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05282602
• Other study ID #: REC/RCR &AHS/22/0201 Maryam
• Status: Completed
• Phase: N/A
• Start date: February 20, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: October 2022
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

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)
• 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.

Locations

Country	Name	City	State
Pakistan	Riphah Rehabilitation Center	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (12)

Cavalcante Neto JL, Steenbergen B, Wilson P, Zamunér AR, Tudella E. Is Wii-based motor training better than task-specific matched training for children with developmental coordination disorder? A randomized controlled trial. Disabil Rehabil. 2020 Sep;42(18):2611-2620. doi: 10.1080/09638288.2019.1572794. Epub 2019 Feb 22. — View Citation

Cicek A, Ozdincler AR, Tarakci E. Interactive video game-based approaches improve mobility and mood in older adults: A nonrandomized, controlled tri?al. J Bodyw Mov Ther. 2020 Jul;24(3):252-259. doi: 10.1016/j.jbmt.2020.01.005. Epub 2020 Feb 6. — View Citation

Cimino V, Chisari CG, Raciti G, Russo A, Veca D, Zagari F, Calabrò RS, Patti F. Objective evaluation of Nintendo Wii Fit Plus balance program training on postural stability in Multiple Sclerosis patients: a pilot study. Int J Rehabil Res. 2020 Sep;43(3):199-205. doi: 10.1097/MRR.0000000000000408. — View Citation

Hung ES, Chen SC, Chang FC, Shiao Y, Peng CW, Lai CH. Effects of Interactive Video Game-Based Exercise on Balance in Diabetic Patients with Peripheral Neuropathy: An Open-Level, Crossover Pilot Study. Evid Based Complement Alternat Med. 2019 Mar 6;2019:4540709. doi: 10.1155/2019/4540709. eCollection 2019. — View Citation

Jeon MJ, Jeon HS, Yi CH, Kwon OY, You SH, Park JH. Block and Random Practice: A Wii Fit Dynamic Balance Training in Older Adults. Res Q Exerc Sport. 2021 Sep;92(3):352-360. doi: 10.1080/02701367.2020.1733456. Epub 2020 May 13. — View Citation

Kaur S, Koley SJJ. Effectiveness of trunk balance exercises and wii fit TM balance exercises in managing disability and pain in patients with chronic low back pain. 2019.

Khan KS, Andersen H. The Impact of Diabetic Neuropathy on Activities of Daily Living, Postural Balance and Risk of Falls - A Systematic Review. J Diabetes Sci Technol. 2022 Mar;16(2):289-294. doi: 10.1177/1932296821997921. Epub 2021 Mar 14. — View Citation

Marques-Sule E, Arnal-Gómez A, Buitrago-Jiménez G, Suso-Martí L, Cuenca-Martínez F, Espí-López GV. Effectiveness of Nintendo Wii and Physical Therapy in Functionality, Balance, and Daily Activities in Chronic Stroke Patients. J Am Med Dir Assoc. 2021 May;22(5):1073-1080. doi: 10.1016/j.jamda.2021.01.076. Epub 2021 Feb 24. — View Citation

Pavana NAP, Ghosh AJEAB. Effectiveness of Core Stability Exercise and Proprioception Exercise on Balance in Subjects with Diabetic Neuropathy-A Randomized Controlled Trial. 2021;15(3):81.

Reeves ND, Orlando G, Brown SJ. Sensory-Motor Mechanisms Increasing Falls Risk in Diabetic Peripheral Neuropathy. Medicina (Kaunas). 2021 May 8;57(5). pii: 457. doi: 10.3390/medicina57050457. Review. — View Citation

Watkhuma A, Boonyaroma O, Srisupornkornkoolb K. Effect of Wii Balance Board and motor imagery on balance and muscle strength in football players

Yuan RY, Chen SC, Peng CW, Lin YN, Chang YT, Lai CH. Effects of interactive video-game-based exercise on balance in older adults with mild-to-moderate Parkinson's disease. J Neuroeng Rehabil. 2020 Jul 13;17(1):91. doi: 10.1186/s12984-020-00725-y. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

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