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OsteoporosisNCT07364279

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

A study testing Wii fit balance board, traditional balance exercise and Calcium supplement in people with Osteoporosis and Mastectomy, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 60 years, women only
Conditions the study is for
Osteoporosis, Mastectomy
What is being tested?
Wii fit balance board, traditional balance exercise and Calcium supplement
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
5 Nov 2024to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Cairo University

    Cairo, 02

Other trials in Egypt

About this study

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.

Read the 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.

Being tested
Wii fit balance board, traditional balance exercise, Calcium supplement
Keywords
osteoporosis post mastectomy, females, balance, EFFECT OF WII FIT BALANCE BOARD GAMES
Medical subject headings
Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wii fit balance boardDevice

    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.

  • traditional balance exerciseOther

    traditional balance exercise

  • Calcium supplementDrug

    Also called vitamens

    traditional treatment

Study groups in NCT07364279
Study groupRoleWhat they receive
Study group (Wii Fit groupExperimentalThis 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.
Receives: Device: Wii fit balance board; Other: traditional balance exercise; Drug: Calcium supplement
Control group:Active comparatorThis 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.
Receives: Other: traditional balance exercise; Drug: Calcium supplement

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at baseline and after 8 weeks

Secondary outcomes (1)

  1. 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.

    Measured: at baseline and after 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start5 Nov 2024
  3. Primary completion5 Nov 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07364279
Sponsor's protocol ID
012/003323
Other IDs
Linda Raafat Daniel
Status last verified
Jan 2026
First submitted
10 Jun 2025
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing Wii fit balance board, traditional balance exercise and Calcium supplement in people with Osteoporosis and Mastectomy, run by Cairo University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Berg Balance Scale (BBS). (time frame: at baseline and after 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07364279, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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