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

NCT07364279 | Completed

• 2 other identifiers: 012/003323Linda Raafat Daniel
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoporosis; Mastectomy

Keywords

osteoporosis post mastectomy; females; balance; EFFECT OF WII FIT BALANCE BOARD GAMES

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assessment of balance using the Wii Fit balance board

  at baseline and after 8 weeks

Study Arms (2)

Study group (Wii Fit group

EXPERIMENTAL

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; Other: traditional balance exercise; Drug: Calcium supplement

Control group:

ACTIVE COMPARATOR

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; Drug: Calcium supplement

Interventions

Wii fit balance board DEVICE

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.

Study group (Wii Fit group

traditional balance exercise OTHER

traditional balance exercise

Control group:; Study group (Wii Fit group

Calcium supplement DRUG

traditional treatment

Also known as: vitamens

Control group:; Study group (Wii Fit group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The subject selection will be according to the following criteria:
• All patients are female.
• Age ranges from 40\_60 years.
• All patients suffering from balance dysfunctions resulting from osteoporosis after mastectomy.
• All participants will have informed consent to participate in this study.
• All patients will participate in the study after 6 months of receiving chemotherapy and diagnosed with osteoporosis.
• All patients will follow the same diet .
• Ability to stand and ambulate independently

You may not qualify if:

• Patients will be excluded from the study if they met any of the following criteria:
• Patients with visual or hearing, vestibular impairment. 25
• Patients with Previous breast cancer surgery on the present or contralateral side.
• Patients receiving hormonal therapy
• Patients with Active or metastatic cancer focus.
• Patients with Venous thrombosis.
• Osteoarticular and/or Rheumatological disorders, significantly disturbing balance.
• Patients with severe orthopedic injuries to the lower extremities (e.g. Ankle fracture, joint fusion or joint replacement).
• Patients with neurological disturbances that cause impaired balance such as hemiparesis, ataxia, vertigo and vestibular disturbances.
• Patients with mental disorders.
• Pregnant patients.
• Patients with diabetes mellitus.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 02, Egypt

Location

Related Publications (1)

• 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

  BACKGROUND

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: January 23, 2026
• Study Start: November 5, 2024
• Primary Completion: November 5, 2025
• Study Completion: December 1, 2025
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

EG (1)