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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Pain using Numerical Rating Scale (NRS)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Concealed allocation will be performed by a researcher who will not be involved in the treatment of assessment. Permuted blocks will be used to ensure an equal 1:1 allocation ratio. Due to the nature of the study, the assessor and the data analyzer will be blindfolded (double-blinded)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
virtual reality
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
干预措施: exercises using virtual reality technology (Other)
regular exercises
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
干预措施: exercises using virtual reality technology (Other)
结局指标
主要结局
Pain using Numerical Rating Scale (NRS)
时间窗: after the end of the treatment (after 8 weeks)
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
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: after the end of the treatment (after 8 weeks)
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.
wrist joint active range of motion (ROM)
时间窗: baseline
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Fatigue by Multidimensional Fatigue Inventory
时间窗: after the end of the treatment (after 8 weeks)
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.
Anxiety by The State Anxiety Inventory (SAI)
时间窗: after the end of the treatment (after 8 weeks)
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
Handgrip strength
时间窗: at baseline
will be measured by Pablo system for the affected and unaffected upper limbs
handgrip strength
时间窗: after the end of the treatment (after 8 weeks)
will be measured by Pablo system for the affected and unaffected upper limbs
wrist joint active ROM
时间窗: after the end of the treatment (after 8 weeks)
flexion and extension active ROM of the wrist joints will be assessed using Pablo system
Disabilities of the Arm, Shoulder and Hand (DASH)
时间窗: at baseline
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.
Fatigue by Multidimensional Fatigue Inventory
时间窗: at baseline
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.
Anxiety by The State Anxiety Inventory (SAI)
时间窗: at baseline
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
Pain using Numerical Rating Scale (NRS)
时间窗: at baseline
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
次要结局
未报告次要终点
研究者
Ahmed Abdelmoniem Ibrahim
principal investigator
University of Hail