Exercises Using Virtual Reality on Cancer Patients

Study Overview
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Brief Summary
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in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment

Detailed Description
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in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment. A virtual reality (VR) environment is created by combining computer systems and sensor technology with the use of three-dimensional graphics and enabling users to experience a more real, immersive experience by utilizing their various senses (vision, hearing, touch, etc.) through the use of the computer and sensor technologies and it is characterized by immersion, imagination, and interaction 2 groups will be selected randomly to receive experimental and control intervention for 1 month and outcomes will be collected before and after treatment.

Official Title
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Effectiveness of Virtual Reality Using Pablo Game Training Program on Upper Extremity Muscle Strength, Pain, Function and Activity of Daily Living in Post-operative Breast Cancer Female Patients.

Conditions
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Breast Cancer Female

Intervention / Treatment
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* Other: exercises using virtual reality technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer female patients Age ≥40 years All patients with Eastern Cooperative Oncology Group performance status score ≤ 2 Having to undergo primary treatment with surgery, chemotherapy, and/or radiotherapy based on the patient's need Exclusion Criteria: Severe anemia (Hb ≤ 8 g/dL) Uncontrolled hypertension, diabetes severe infection, neurologic or muscular diseases prohibiting physical activity severe heart disease or myocardial infarction during the last six months, and a severe chronic obstructive pulmonary disease uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising Contraindications given by the physician

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized controlled trial with 2 arms parallel design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality<br>The patients in this group are under exercise training and pneumatic pressure followed by Pablo©Handle training for 45 minutes per week for 8 week -Pablo©Handle training One-dimensional therapy games using five games are available for Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Apple hunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week | Other: exercises using virtual reality technology<br>* this is a one-dimensional therapy game using (Handle/ or Multiball) five games are available for the Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Applehunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week<br>* Other names: Pablo©Handle training;|
| Active Comparator: regular exercises<br>The patients in this group will receive exercise training and pneumatic pressure only for 30 min3 times per week for 8 week Exercise training will be done by the following exercise for 15 min3 times per week for 8 week Intermittent Compression Therapy Parameters: using the (Care Pump expert 8) Pressure. 60 mmHg, Direction. Distal to proximal, Speed 4 to 5, for 15 min /3 times per week for 8 week | Other: exercises using virtual reality technology<br>* this is a one-dimensional therapy game using (Handle/ or Multiball) five games are available for the Pablo©Handle which are (Recycle, Firefighters, Shooting Cans, Balloon, and Applehunter) The session will be 3 min for each game about 15 min for each session 3 times per week for 8 week<br>* Other names: Pablo©Handle training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handgrip strength | will be measured by Pablo system for the affected and unaffected upper limbs | at baseline | 
| handgrip strength | will be measured by Pablo system for the affected and unaffected upper limbs | after the end of the treatment (after 8 weeks) | 
| wrist joint active range of motion (ROM) | flexion and extension active ROM of the wrist joints will be assessed using Pablo system | baseline | 
| wrist joint active ROM | flexion and extension active ROM of the wrist joints will be assessed using Pablo system | after the end of the treatment (after 8 weeks) | 
| Disabilities of the Arm, Shoulder and Hand (DASH) | DASH is a 30-item questionnaire. Each item is scored on a 1 (no difficulty) to 5 (unable) scale. The total score may range from 0 to 100 points. High scores indicate a high level of disability. | at baseline | 
| Disabilities of the Arm, Shoulder and Hand (DASH) | DASH is a 30-item questionnaire. Each item is scored on a 1 (no difficulty) to 5 (unable) scale. The total score may range from 0 to 100 points. High scores indicate a high level of disability. | after the end of the treatment (after 8 weeks) | 
| Fatigue by Multidimensional Fatigue Inventory | The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. | at baseline | 
| Fatigue by Multidimensional Fatigue Inventory | The MFI is a 20-item self-report instrument designed to measure fatigue. It covers the following dimensions: general fatigue, physical fatigue, reduced activity, reduced motivation, and mental fatigue. | after the end of the treatment (after 8 weeks) | 
| Anxiety by The State Anxiety Inventory (SAI) | SAI is a valid and commonly used measure for anxiety The SAI includes 20 items; each item is scored on a 4-point Likert scale The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety | at baseline | 
| Anxiety by The State Anxiety Inventory (SAI) | SAI is a valid and commonly used measure for anxiety The SAI includes 20 items; each item is scored on a 4-point Likert scale The SAI range of total scores is between 20 and 80, with the higher score indicating more anxiety | after the end of the treatment (after 8 weeks) | 
| Pain using Numerical Rating Scale (NRS) | this scale is valid and reliable measure of pain intensity. the patient is asked to rate pain intensity be choosing a number from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain ever | at baseline | 
| Pain using Numerical Rating Scale (NRS) | this scale is valid and reliable measure of pain intensity. the patient is asked to rate pain intensity be choosing a number from 0 to 10 where 0 indicates no pain and 10 indicates the worst pain ever | after the end of the treatment (after 8 weeks) |