| 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
|
|
|
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
|
|
|
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 .
|