Study the Effect of Tele-Physiotherapy on Shoulder Mobility, strength, Pain, and Quality of Life in modified radical mastectomy Patients: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- a) QuickDASH (Disabilities of Arm, Shoulder and Hand
研究概览
简要总结
This study will employ a double-blinded, parallel-group RCT design. Participants will be randomly assigned to either the intervention group (tele-physiotherapy) or the Conventional group after taking informed consent. Assessments (Outcome measures) will be conducted at baseline (post op. 5th day), post-intervention (week 4) of modified radical mastectomy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients, who were undergone recent extended mastectomy.
- •Patients, who will meet certain functional critera, like shoulder flexion and abduction ROM equal to or greater than 90 degree , internal and external rotation ROM greater than equal to 45degree .
- •Patients, who speak and understand Hindi and English.
- •Patients, who can access to electronic video reproduction equipment (android/ios phone/ tablet).
- •Patients, who don’t have past or active psychiatric conditions.
排除标准
- •Patients, who are having blindness and visual impairments
- •Patients, who are performed bilateral mastectomy or breast reconstruction surgery
- •Patients, who are inability to perform preoperative assessment movements, due to previous upper limb injury or conditions.
- •Patients, who are having sever inflammatory processes in the ipsilateral limb to the surgery.
结局指标
主要结局
a) QuickDASH (Disabilities of Arm, Shoulder and Hand
时间窗: baseline data- Post operative 5th day, post data- after 4 weeks of intervention
b) Active Range of Motion (AROM) of shoulder by goniometer
时间窗: baseline data- Post operative 5th day, post data- after 4 weeks of intervention
c) Visual Analogus Scale (VAS)
时间窗: baseline data- Post operative 5th day, post data- after 4 weeks of intervention
d) FACT-B (Functinal Assessment of Cancer Therapy- Breast)
时间窗: baseline data- Post operative 5th day, post data- after 4 weeks of intervention
e) Strength of shoulder muscles by Dynamometer
时间窗: baseline data- Post operative 5th day, post data- after 4 weeks of intervention
次要结局
未报告次要终点
研究者
Avilash Mohapatra
AIIMS, New Delhi