FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097586 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 10/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   A study on effect of diagonal patterns of shoulder exercises for improving shoulder range of movement among patients following heart surgery within the period of hospital stay . 
Scientific Title of Study   Proprioceptive Neuromuscular Facilitation for improving shoulder range in immediate post cardiac surgery patients-Single blinded Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anna George 
Designation  Student 
Affiliation  Christian Medical College, Vellore 
Address  Anna George B.P.T Batch 2021 Department of Physiotherapy Christian Medical College, Vellore Tamil Nadu

Vellore
TAMIL NADU
632004
India 
Phone  9605531439  
Fax    
Email  anna.george.ahs21@cmcvellore.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  John Samuel M 
Designation  Assistant Professor 
Affiliation  Christian Medical College ,Vellore 
Address  Department of Physiotherapy Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7092025510  
Fax    
Email  john.m@cmcvellore.ac.in  
 
Details of Contact Person
Public Query
 
Name  John Samuel M 
Designation  Assistant Professor 
Affiliation  Christian Medical College ,Vellore 
Address  Department of Physiotherapy Christian Medical College, Vellore

Vellore
TAMIL NADU
632004
India 
Phone  7092025510  
Fax    
Email  john.m@cmcvellore.ac.in  
 
Source of Monetary or Material Support  
Internal Fluid Research Grant Office of Research Christian Medical College Vellore Tamil Nadu, India PIN- 632002 
 
Primary Sponsor  
Name  Internal -Fluid Research Grant 
Address  Office of Research Christian Medical College Vellore Ida Scudder Road ,Vellore PIN-632004 
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 
Dr Pierre Edwin D PT  Christian Medical College Vellore   Room Number C201,B302 Department of Cardio thoracic and Vascular Surgery , Christian Medical College Vellore, Ranipet Campus PIN-632401
Vellore
TAMIL NADU 
9894419533

pierre.edwin@cmcvellore.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board (Silver Ethics and Research Committee)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M750||Adhesive capsulitis of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Therapy  Group 1- Only Conventional Therapy The participants receive normal Shoulder Range of Motion in a single plane and breathing exercises. 
Intervention  Proprioceptive Neuromuscular Facilitation Diagonal Pattern Exercises for Upper Limb and Conventional Physiotherapy  GROUP 2- Conventional Therapy and PNF. Conventional Therapy involves normal Range of Motion exercises for shoulder in single plane and breathing exercises. For interventional group two types of patterns will also be applied along with the conventional therapy .This involves shoulder motion starting from one position and ending in other position according to PNF movement patterns- D1 Flexion- Extension and D2 Flexion – Extension as follows PATTERN D1 Shoulder Flexion then Adduction and External Rotation that was started at Shoulder Extension then Abduction and Internal Rotation. PATTERN D2: Shoulder Flexion then Abduction and External Rotation that was started at Shoulder Extension then Adduction and Internal Rotation. The patient will be advised to perform the patterns thrice daily for 10 times in each set and 2 sets for each session.  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Age 19 years to 65 years

Gender including both male and female

Patients who have undergone median sternotomy for cardiac surgery 
 
ExclusionCriteria 
Details  Previous neurological disorders affecting the cervical spine and upper limb

Any systemic or inflammatory joint disease of shoulder

Previous history of any shoulder fractures

Poor Cognitive or mental status 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Range of Motion of shoulder - external rotation abduction and flexion using Inertial Measurement Unit(IMU)
 
Baseline before surgery
After 1 week post surgery
After 3 months follow up post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Shoulder pain using Numeric Pain Rating Scale (NPRS)

Shoulder function using University of California Los Angeles (UCLA) Shoulder Rating Scale
 
Baseline before surgery
After 1 week post surgery
After 3 months follow up post surgery 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 3 
Date of First Enrollment (India)   24/11/2025 
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="7"
Days="27" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  
In this single blinded randomized controlled trial we aim to find out if addition of Proprioceptive Neuromuscular Facilitation (PNF) movement patterns to conventional therapy improves shoulder range of motion shoulder function and reduces pain  when compared to conventional therapy alone in immediate post cardiac surgery patients through median sternotomy.
Persons admitted in cardiothoracic unit for cardiac surgery through median sternotomy will be screened for eligibility by the principal investigator and will be included pre-operatively after a written consent. Baseline assessment will be performed pre-operatively by a physical therapist (PT1) who will be blinded to the group allocation  which will include assessment of shoulder range of motion - external rotation  abduction and flexion using inertial measuring unit (IMU) pain evaluation using Numerical pain rating scale (NPRS) and shoulder functional activity will be evaluated using University of California  Los Angeles (UCLA) Shoulder Rating Score. The UCLA Shoulder Rating Scale which is already part of our outcome measures  includes a specific question assessing patient satisfaction with shoulder function and pain. Hence  this scale will capture both functional improvement and the patient’s subjective satisfaction with recovery. Following cardiac surgery through median sternotomy participants will be randomly allocated to either control or interventional group using sequentially numbered opaque sealed envelopes (SNOSE). Control group will receive 1 week of conventional therapy  which consists of active shoulder range of motion exercises while the interventional group will receive 1 week of PNF shoulder exercise in addition to conventional therapy. The PNF pattern exercises which will be used in this study are D1 Flexion – Extension (diagonal pattern 1) and D2 Flexion – Extension (diagonal pattern 2) of Upper Limb. At the end of 1 week the same outcomes will be re-assessed to find out and compare the effect of PNF pattern exercise  when used in addition to conventional therapy versus conventional therapy alone on range of motion, pain and shoulder function. . Each participant will receive 1 week of supervised therapy in the hospital followed by a home exercise program sheet to continue the prescribed exercises independently. After 3 months participants will return for follow-up assessment  and all outcome measures will be reassessed to evaluate long-term effects. At 3 month follow-up  outcomes will be re- assessed to determine the incidence of adhesive capsulitis in post-operative cardiac patients. Only trained and qualified physiotherapists of the institution will deliver all interventions . 

 
Close