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临床试验/CTRI/2022/05/042930
CTRI/2022/05/042930招募中不适用

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

DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年1月6日最近更新:

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)

研究者

发起方
DR APJ ABDUL KALAM COLLEGE OF PHYSIOTHERAPY
申办方类型
Private medical college

研究点 (1)

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