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Clinical Trials/NCT07364279
NCT07364279
Completed
Not Applicable

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

Cairo University1 site in 1 country60 target enrollmentStarted: November 5, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Berg Balance Scale (BBS).

Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: Wii fit balance board (Device)

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.

Intervention: traditional balance exercise (Other)

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.

Intervention: Calcium supplement (Drug)

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.

Intervention: traditional balance exercise (Other)

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.

Intervention: Calcium supplement (Drug)

Outcomes

Primary Outcomes

Berg Balance Scale (BBS).

Time Frame: at baseline and after 8 weeks

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.

Secondary Outcomes

  • assessment of balance using the Wii Fit balance board(at baseline and after 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

linda raafat daniel

principal investigator

Cairo University

Study Sites (1)

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