NCT05282602

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

February 20, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

5 months

First QC Date

February 20, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

Wii FitProprioceptiveFallBalanceDiabetic Neuropathy

Outcome Measures

Primary Outcomes (4)

  • 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

  • STAR Excursion test

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

    6th Week

  • 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

  • Timed Up and Go Test

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

    6th Week

Study Arms (2)

Wii Fit Based Exercises

EXPERIMENTAL

Group A will receive Wii fit Based Exercises

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

Proprioceptive Training

EXPERIMENTAL

Group B will receive proprioceptive training

Other: Proprioceptive exercises

Interventions

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)

Wii Fit Based 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.

Proprioceptive Training

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (13)

  • 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.

    PMID: 34066681BACKGROUND
  • 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.

    PMID: 33719603BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 32401683BACKGROUND
  • 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.

    PMID: 30794762BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 33639116BACKGROUND
  • 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.

    PMID: 32825997BACKGROUND
  • 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.

    PMID: 32371848BACKGROUND
  • Watkhuma A, Boonyaroma O, Srisupornkornkoolb K. Effect of Wii Balance Board and motor imagery on balance and muscle strength in football players

    BACKGROUND
  • 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.

    PMID: 32660512BACKGROUND
  • 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.

    PMID: 30956680BACKGROUND
  • Rehman SSU, Hassan D, Ikram M, Ikram M. Effects of Wii Fit-based Exercises versus proprioceptive training on balance and fall risk in patients with diabetic neuropathy. Pak J Med Sci. 2025 Feb;41(2):393-398. doi: 10.12669/pjms.41.2.8775.

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Syed Shakil Ur Rehman, PhD

    Riphah International University

    STUDY CHAIR
  • Maryam Ikram, MSPT(NM)*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

March 16, 2022

Study Start

February 20, 2022

Primary Completion

July 30, 2022

Study Completion

August 30, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations