| CTRI Number |
CTRI/2025/11/096968 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercise combined with music for the
immediate post-operative management of individuals who have undergone total
knee replacement surgery. |
|
Scientific Title of Study
|
Music Therapy for early rehabilitation of persons
with total knee arthroplasty: A 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 |
Ashruto Dey |
| Designation |
Bachelor of Physiotherapy IV year student |
| Affiliation |
Christian Medical College Vellore |
| Address |
Physiotherapy Department
Christian Medical College Vellore
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
9083249100 |
| Fax |
|
| Email |
ashrutodey@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Merlyn R |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Physiotherapy Department
Christian Medical College
Vellore
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
6380603255 |
| Fax |
|
| Email |
merlyntilak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Merlyn R |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College Vellore |
| Address |
Physiotherapy Department
Christian Medical College
Vellore
Vellore
Vellore
TAMIL NADU
632002
India |
| Phone |
6380603255 |
| Fax |
|
| Email |
merlyntilak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional Review Board, Christian Medical College Vellore, Vellore 632002, Tamil Nadu, South India. |
|
|
Primary Sponsor
|
| Name |
NO |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Merlyn R |
Christian Medical College Vellore |
Room No. 6,Physiotherapy Department, Christian Medical College Vellore
Vellore, 632002, Tamil Nadu, South India
Vellore
TAMIL NADU |
9444463948
merlyntilak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD (IRB) OFFICE OF RESEARCH CHRISTIAN MEDICAL COLLEGE VELLORE, INDIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M255||Pain in joint, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional physiotherapy |
conventional physiotherapy for total knee arthroplasty for 2 weeks |
| Intervention |
music therapy |
music therapy + conventional physiotherapy for total knee
arthroplasty for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients admitted for total knee arthroplasty
2.Age group from 50 to 80 years
3.Both genders |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing revision knee arthroplasty.
2. Patients presenting with deformities in other joint due
ankylosing spondylitis, rheumatoid arthritis.
3. Patients having hearing difficulty |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pain : VAS
Knee range :Universal goniometer and
accelerometer
Quadriceps strength:Modified Oxford scale and Hand-
held dynamometer |
Pain:Day 1 and Day 12
Knee range: Day 1 and Day 12
Quadriceps strength:Day 1 and Day 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Knee function :KOOS scale
Ambulatory status :2-minute walk test, 10-metre walk |
Knee function : Day 1 and Day 12
Ambulatory status : Day 12 |
|
|
Target Sample Size
|
Total Sample Size="114"
Sample Size from India="114"
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)
|
18/11/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
Modification(s)
|
Persons who have undergone total knee arthroplasty (TKA) in the orthopedic
department, CMC Vellore, will be assessed for eligibility by the Principal Investigator and
included in the study after obtaining written consent.
An initial assessment will be performed by the physical therapist (Outcome assessor)
who will be blinded to the group allocation. The assessment will include measurement of
pain using Visual Analogue Scale (VAS), knee flexion and extension range using a
universal goniometer and an accelerometer, muscle power using Modified Oxford scale
for manual muscle testing and hand-held dynamometer, knee function will be assessed
using Knee injury and Osteoarthritis Outcome Score (KOOS) .Following this, the patients
will be randomized using sequentially numbered, opaque, sealed envelope (SNOSE) to
two groups. The ambulatory status shall be assessed after 3 days of surgery when patients are able to walk independently by using the 2 minute and 10 meter walk test .
The interventional group will receive music therapy in addition to two weeks of
conventional physiotherapy (PT). The control group will receive only two weeks of
standard PT. During music therapy, patients will listen to music of their choice through
earphones in one ear, while the other ear remains unobstructed to hear commands from
the physical therapist conducting the conventional PT. Conventional PT will include
exercises of the TKA protocol (Appendix I – TKA protocol), which will include isometric
exercises, multiangled isometrics, dynamic knee strengthening exercises, and
progressive gait training. This will be progressed until suture removal (12th post-op day).
At the end of two weeks, the outcomes will be re-assessed by the physical therapist
(blinded outcome assessor). The data will be analyzed to find out if the addition of music
therapy to a two–week conventional PT helped in reducing pain and improving the joint
range of motion and muscle strength when compared to the control group. In addition,
,hospital related anxiety and patient experience will also be analysed. |