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CTRI Number  CTRI/2026/01/102008 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of tele-physiotherapy 
Scientific Title of Study   Study the Effect of Tele-Physiotherapy on Shoulder Mobility, strength, Pain, and Quality of Life in modified radical mastectomy Patients: A Randomized Controlled Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avilash Mohapatra 
Designation  Junior Physiotherapist 
Affiliation  AIIMS, New Delhi 
Address  Physiotherapy Unit, Surgical Block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  7978277571  
Fax    
Email  physioavilash09@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Avilash Mohapatra 
Designation  Junior Physiotherapist 
Affiliation  AIIMS, New Delhi 
Address  Physiotherapy Unit, Surgical Block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  7978277571  
Fax    
Email  physioavilash09@gmail.com  
 
Details of Contact Person
Public Query  
Name  Avilash Mohapatra 
Designation  Junior Physiotherapist 
Affiliation  AIIMS, New Delhi 
Address  Physiotherapy Unit, Surgical Block, AIIMS, New Delhi

New Delhi
DELHI
110029
India 
Phone  7978277571  
Fax    
Email  physioavilash09@gmail.com  
 
Source of Monetary or Material Support  
AIIMS, New Delhi 
 
Primary Sponsor  
Name  AIIMS, New Delhi 
Address  AIIMS, New Delhi, Ansari Nagar-110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Avilash Mohapatra  AIIMS, New Delhi  Department of Surgical Disciplines, AIIMS, New Delhi, Ansari Nagar
New Delhi
DELHI 		 7978277571

physioavilash09@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C50||Malignant neoplasm of breast,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  conventional same exercises through booklet instructions  same exercise through booklet instructions; and continue the exercises for 30-45 minutes, twice weekly for a period of 4 weeks in home without remote support 
Intervention  Telephysiotherapy  Telephysiotherapy protocol (used in RCT by Leonardo Breno de Aviz :2024) through instant messaging application(whatsapp or zoom meeting), for 30-45 minutes, twice weekly for a period of 4 weeks, totaling 8 days of exercises. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  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
 
 
ExclusionCriteria 
Details  1. Patients, who are having blindness and visual impairments
2. Patients, who are performed bilateral mastectomy or breast reconstruction surgery
3. Patients, who are inability to perform preoperative assessment movements, due to previous upper limb injury or conditions.
4. Patients, who are having sever inflammatory processes in the ipsilateral limb to the surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
a) QuickDASH (Disabilities of Arm, Shoulder and Hand
b) Active Range of Motion (AROM) of shoulder by goniometer
c) Visual Analogus Scale (VAS)
d) FACT-B (Functinal Assessment of Cancer Therapy- Breast)
e) Strength of shoulder muscles by Dynamometer 		 baseline data- Post operative 5th day, post data- after 4 weeks of intervention 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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