Effect of Wii Fit Balance Board Games on Balance in Patients With Osteoporosis Post Mastectomy

This study will be a randomized controlled trial. The purpose of the study is to evaluate the therapeutic effect of Wii Fit balance board games on balance in patients with osteoporosis post mastectomy.

Study Overview

• Status: Completed
• Conditions: Osteoporosis; Mastectomy
• Intervention / Treatment: Device: Wii fit balance board; Other: traditional balance exercise; Drug: Calcium supplement

Detailed Description

Women with breast cancer face an increased risk of osteoporosis, necessitating screening and treatment to prevent fractures due to aging and treatment effects. Osteoporosis exacerbates balance issues, raising fall risks among these patients. The treatments often lead to accelerated bone loss and compromised musculoskeletal support, amplifying their vulnerability to fractures. Integrated management strategies that enhance bone health and balance rehabilitation are essential for this group. Post-mastectomy systematic movement exercises are vital for maintaining activity and preventing posture issues, significantly improving balance. Additionally, the use of interactive systems like Wii Fit has shown to effectively aid balance training and improve overall physical function for breast cancer patients, making it a valuable component of at-home rehabilitation programs to reduce fall risk and enhance quality of life.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 02
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The subject selection will be according to the following criteria:

  1. All patients are female.
  2. Age ranges from 40_60 years.
  3. All patients suffering from balance dysfunctions resulting from osteoporosis after mastectomy.
  4. All participants will have informed consent to participate in this study.
  5. All patients will participate in the study after 6 months of receiving chemotherapy and diagnosed with osteoporosis.
  6. All patients will follow the same diet .
  7. Ability to stand and ambulate independently

Exclusion Criteria:

• Patients will be excluded from the study if they met any of the following criteria:

  1. Patients with visual or hearing, vestibular impairment. 25
  2. Patients with Previous breast cancer surgery on the present or contralateral side.
  3. Patients receiving hormonal therapy
  4. Patients with Active or metastatic cancer focus.
  5. Patients with Venous thrombosis.
  6. Osteoarticular and/or Rheumatological disorders, significantly disturbing balance.
  7. Patients with severe orthopedic injuries to the lower extremities (e.g. Ankle fracture, joint fusion or joint replacement).
  8. Patients with neurological disturbances that cause impaired balance such as hemiparesis, ataxia, vertigo and vestibular disturbances.
  9. Patients with mental disorders.
  10. Pregnant patients.
  11. Patients with diabetes mellitus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group (Wii Fit group; This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive Wii Fit balance board exercises for 3 sessions per week for 8 weeks, in addition to traditional balance exercises and the routine medical treatment.	Device: Wii fit balance board; Wii fit balance board Compose of Hardware which comprised of a regular PC, a 10" LCD screen and a Wii Fit balance board. The correspondence between this device and the screen was set up by means of Bluetooth convention. Along these lines, the activities run on a PC and the framework utilized the WBB as interface. A platform has sensors that action weight and center point of gravity . The software is Darwiin Remote . The average displacement of the center of gravity was determined to assess the equilibrium status. The force plate has 4 strain gauges and can measure the tension got from changes in posture and was associated with a PC screen. The center of gravity point can be shown on the screen to give a client visual input and to gauge the equilibrium status. The four sensors yet to be determined board can detect weight changes and show the distribution of body weight. The 4 sensors measure weightcan be added to get the body loads of individual clients.; Other: traditional balance exercise; traditional balance exercise; Drug: Calcium supplement; traditional treatment; Other Names: vitamens
Active Comparator: Control group: This group includes thirty female patients suffering from balance dysfunction resulting from osteoporosis post mastectomy. They will receive traditional balance exercises in addition to the routine medical treatment for 3 sessions per week for 8 weeks.	Other: traditional balance exercise; traditional balance exercise; Drug: Calcium supplement; traditional treatment; Other Names: vitamens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS).	The Berg Balance Scale consists of 14 items, each scored on an ordinal scale from 0 to 4 (0 = unable to perform, 4 = normal performance). Document the baseline scores for each item. Tasks Included: Sitting balance. Standing balance. Dynamic balance. Scoring: Total possible score is 56 points. Higher scores indicate better balance. Post-Treatment Assessment: Re-evaluate the patient using the same BBS after eight weeks of treatment.	at baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of balance using the Wii Fit balance board	Instruct the patient to stand on the Wii Fit balance board. Measure the center of pressure (COP) results. The balance board estimates the pressure contributed by the left and right halves of the body. Ideal center of pressure proportion is 50/50 or 1.00 Instruct the patient to stand on the Wii Fit balance board.	at baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• Arshad, H., Khattak, H., Anwar, K., Majeed, Y., & Malakandi, H. B. (2022). Comparison of exergames versus traditional balance exercise to improve balance and reduce risk of falls in chronic stroke patients. Journal of Medical Sciences (Peshawar), 30, 134- 138. https://doi.org/10.52764/jms.22.30.2.7 Blackie, R. (2020). Diagnosis, assessment and management of osteoporosis. Prescriber, 31, 14-19. https://doi.org/10.1002/psb.1815 Cabanas-Valdés, R., Boix-Sala, L., Grau-Pellicer, M., Guzmán-Bernal, J. A., Caballero-Gómez, F. M., & Urrútia, G. (2021). The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. International Journal of Environmental Research and Public Health, 18(12), 6615. https://doi.org/10.3390/ijerph18126615 Castañeda, S., Casas, A., González-del-Alba, A., Martínez-Díaz-Guerra, G., Nogués, X., Ojeda Thies, C., Torregrosa Suau, Ó., & Rodríguez-Lescure, Á. (2022). Bone loss induced by cancer treatments in breast and prostate cancer patients. Clinical & 37 Translational Oncology, 24(11), 2090-2106. https://doi.org/10.1007/s12094-022-02872-1 Choksi, P., Williams, M., Clark, P. M., & Van Poznak, C. (2013). Skeletal Manifestations of Treatment of Breast Cancer. Current Osteoporosis Reports, 11(4), 319-328. https://doi.org/10.1007/s11914-013-0179-7 Clynes, M. A., Cooper, C., Dennison, E. M., Jacobsen, B. K., & Javaid, M. K. (2020). The epidemiology of osteoporosis. British Medical Bulletin, 133(1), 105-117. Czajka, M. L., & Pfeifer, C. (2024). Breast Cancer Surgery. In StatPearls. StatPearls Publishing. http://www.ncbi.nlm.nih.gov/books/NBK553076/ Deans, S. M. (2011). Determining the validity of the Nintendo Wii balance board as an assessment tool for balance. https://doi.org/10.34917/2820752 Doruk Analan, P., & Kaya, E. (2019). Postural Stability in Patients with Lower Li

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2024
• Primary Completion (Actual): November 5, 2025
• Study Completion (Actual): December 1, 2025

Study Registration Dates

• First Submitted: June 10, 2025
• First Submitted That Met QC Criteria: January 15, 2026
• First Posted (Actual): January 23, 2026

Study Record Updates

• Last Update Posted (Actual): January 23, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: females; balance; osteoporosis post mastectomy; EFFECT OF WII FIT BALANCE BOARD GAMES
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Bone Diseases, Metabolic; Nutritional and Metabolic Diseases; Osteoporosis
• Other Study ID Numbers: 012/003323; Linda Raafat Daniel (Registry Identifier: Linda Raafat Daniel)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No