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Wii Fit Based Exercises and Proprioceptive Exercises in Diabetic Neuropathy Patients

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
baseline physical therapy treatment along with Wii Fit based exercises
Proprioceptive exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Wii Fit, Proprioceptive, Fall, Balance, Diabetic Neuropathy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Riphah Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Wii Fit Based Exercises

Proprioceptive Training

Arm Description

Group A will receive Wii fit Based Exercises

Group B will receive proprioceptive training

Outcomes

Primary Outcome Measures

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.
STAR Excursion test
Functional screening tool to assess lower extremity dynamic stability and neuromuscular control
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
Timed Up and Go Test
Assess a person's mobility and requires both static and dynamic balance

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
October 17, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05282602
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 20, 2022 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Wii Fit, Proprioceptive, Fall, Balance, Diabetic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Wii Fit Based Exercises
Arm Type
Experimental
Arm Description
Group A will receive Wii fit Based Exercises
Arm Title
Proprioceptive Training
Arm Type
Experimental
Arm Description
Group B will receive proprioceptive training
Intervention Type
Other
Intervention Name(s)
baseline physical therapy treatment along with Wii Fit based exercises
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
Proprioceptive exercises
Intervention Description
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 Outcome Measure Information:
Title
Berg Balance Scale
Description
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.
Time Frame
6th Week
Title
STAR Excursion test
Description
Functional screening tool to assess lower extremity dynamic stability and neuromuscular control
Time Frame
6th Week
Title
Modified Fall Efficacy scale
Description
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
Time Frame
6th Week
Title
Timed Up and Go Test
Description
Assess a person's mobility and requires both static and dynamic balance
Time Frame
6th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil Ur Rehman, PhD
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maryam Ikram, MSPT(NM)*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah Rehabilitation Center
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34066681
Citation
Reeves ND, Orlando G, Brown SJ. Sensory-Motor Mechanisms Increasing Falls Risk in Diabetic Peripheral Neuropathy. Medicina (Kaunas). 2021 May 8;57(5):457. doi: 10.3390/medicina57050457.
Results Reference
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PubMed Identifier
33719603
Citation
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.
Results Reference
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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.
Results Reference
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PubMed Identifier
32401683
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.
Results Reference
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PubMed Identifier
30794762
Citation
Cavalcante Neto JL, Steenbergen B, Wilson P, Zamuner 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.
Results Reference
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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.
Results Reference
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PubMed Identifier
33639116
Citation
Marques-Sule E, Arnal-Gomez A, Buitrago-Jimenez G, Suso-Marti L, Cuenca-Martinez F, Espi-Lopez 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.
Results Reference
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PubMed Identifier
32825997
Citation
Cicek A, Ozdincler AR, Tarakci E. Interactive video game-based approaches improve mobility and mood in older adults: A nonrandomized, controlled tri̇al. J Bodyw Mov Ther. 2020 Jul;24(3):252-259. doi: 10.1016/j.jbmt.2020.01.005. Epub 2020 Feb 6.
Results Reference
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PubMed Identifier
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Citation
Cimino V, Chisari CG, Raciti G, Russo A, Veca D, Zagari F, Calabro 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.
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Watkhuma A, Boonyaroma O, Srisupornkornkoolb K. Effect of Wii Balance Board and motor imagery on balance and muscle strength in football players
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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.
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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.
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Wii Fit Based Exercises and Proprioceptive Exercises in Diabetic Neuropathy Patients

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