EFFECTIVENESS OF STRUCTURED PHYSICAL THERAPY INTERVENTION VERSUS CONVENTIONAL THERAPY ON SHOULDER DYSFUNCTION, QUALITY OF LIFE AND FATIGUE LEVEL IN PATIENTS WITH MODIFIED RADICAL MASTECTOMY IN A RURAL SETUP- A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Shoulder Range of Motion
研究概览
简要总结
STUDYCONDUCT
All the patientsatisfying above inclusion and exclusion criteria will undergo randomizationallocated in anyone group and further grouped as Experimental and ControlGroup.
RANDOMIZATION
All the patientswill be allocated as per the simple randomization method (lottery method) toany of the above group patient.
Procedure
The Ethical Committee approval will be taken fromInstitutional Ethical Committee of Pravara Institute of Medial Sciences (DU),Loni. The participants taken will be Post operative Breast Cancer patients(Modified Radical Mastectomy) from Surgery Department referred to CommunityPhysiotherapy Department. The participants will be screened on basis ofinclusion and exclusion criteria. Participants will be explained about thepurpose and nature of the study, benefits of intervention, risk involved in thestudy, duration of the study etc. in the language best understood by theparticipants. The participants will be encouraged to clarify queries regardingthe study, if any. An informed consent will be obtained from all theparticipants in accordance with procedures approved by the InstitutionalEthical Committee.
The demographic data will be obtained and a detailedassessment of patients will be done on basis of name, age, height, weight, BMI,present chief complaints, past history, medical and surgical history.
A total of 100 participants will be randomly groupedinto 2 groups by using simple random sampling (lottery method).
**Experimental Group:**Patients will be treated with Physical therapy intervention consisting of Rangeof Motion, Breathing, Stretching, Mobility, Flexibility Exercises, Ambulationand Aerobic Exercise.
**Control Group:**Patients will be instructed about Wound Prevention, Breathing Exercises andActive Range of Motion Exercises.
Theoutcome measures via, ROM, Strength, QoL, Fatigue and endurance level will berecorded after 2,4, 6 weeks exercise protocol and patients will be followed up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- Female
入选标准
- •Women more than 18 years age Clinically diagnosed with breast cancer according to imaging and pathological examination.
- •Surgical treatment of breast includes modified radical mastectomy, Mastectomy, or conservation surgery.
- •Pain VAS score more than 1 Patient willing to participate and giving informed consent.
排除标准
- •Patients with severe deformity, any trauma or diseases affecting muscles and joints such as Rheumatoid Arthritis, skin grafting on or around the shoulder.
- •Previous chronic illness such as diabetes, osteoporosis, renal failure, heart disease.
- •Neurological dysfunction.
- •Patients undergone Recent Shoulder surgery.
结局指标
主要结局
Shoulder Range of Motion
时间窗: The data will be collected at baseline, 2 week, 4 week, 6 week and follow up
strength
时间窗: The data will be collected at baseline, 2 week, 4 week, 6 week and follow up
pain
时间窗: The data will be collected at baseline, 2 week, 4 week, 6 week and follow up
Quality of Life
时间窗: The data will be collected at baseline, 2 week, 4 week, 6 week and follow up
Fatigue Level
时间窗: The data will be collected at baseline, 2 week, 4 week, 6 week and follow up
次要结局
- 1. Endurance -6 MWT(2. BMI)
