| CTRI Number |
CTRI/2024/01/061488 [Registered on: 15/01/2024] Trial Registered Prospectively |
| Last Modified On: |
05/01/2024 |
| 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
|
Comparing two types of exercises, one in which muscle length increases and the other in which the muscle length decreases in persons who
have undergone surgical repair of Knee ligament. |
|
Scientific Title of Study
|
Eccentric versus Concentric exercises for Quadriceps strengthening in
persons who have undergone anterior cruciate ligament reconstruction –Single blinded Randomized
Control 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 |
Merlyn R |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room No.8,
Physiotherapy Unit,
PMR department.
Christian Medical College, Vellore, - 632 004
Vellore TAMIL NADU 632004 India |
| Phone |
09444463948 |
| Fax |
04162282035 |
| Email |
merlyntilak@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Merlyn R |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room No.8,
Physiotherapy Unit,
PMR department.
Christian Medical College, Vellore, - 632 004
Vellore TAMIL NADU 632004 India |
| Phone |
09444463948 |
| Fax |
04162282035 |
| Email |
merlyntilak@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Merlyn R |
| Designation |
Associate Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Room No.8,
Physiotherapy Unit,
PMR department.
Christian Medical College, Vellore, - 632 004
Vellore TAMIL NADU 632004 India |
| Phone |
09444463948 |
| Fax |
04162282035 |
| Email |
merlyntilak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Internal fluid research grant
Office of Research, 1st Floor, Carman Block,
Bagayam, Vellore 632 002, India.
E-mail: research@cmcvellore.ac.in.
Tel: 0416 -2284294, Fax: 0416 – 2262788
|
|
|
Primary Sponsor
|
| Name |
Internal fluid research grant |
| Address |
Institutional Review Board,
Christian Medical College, Vellore- 632002
|
| Type of Sponsor |
Private medical college |
|
|
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.8,
Physiotherapy Unit,
PMR department.
Christian Medical College, Vellore, - 632 004 Vellore TAMIL NADU |
09444463948 04162282035 merlyntilak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M236||Other spontaneous disruption of ligament(s) of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Concentric exercises |
In high sitting position, lift the leg from flexion to straight knee position and hold for 5 secs in that position before bringing it to the starting position.
Repeat this for 10 repetitions, 3 sets, 5 times a day.
|
| Intervention |
Eccentric exercises |
In high sitting position,
gently bend the leg from straightened knee to flexion.
Repeat this for 10 repetitions, 3 sets, 5 times a day.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Moderately active before the injury
2. Concurrent injury to the MCL, Meniscectomy |
|
| ExclusionCriteria |
| Details |
1. Previous fracture or reconstruction surgery in the lower limb
2. surgery of both the limbs revision surgery, inflammatory disease and other articular disease.
3. Concurrent injury to the PCL, LCL |
|
|
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 |
| Muscle Strength: Modified Oxford Scale |
1. At Baseline
2. Post-op day 3
3. 2 weeks Post-op
4. 6 months follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) Muscle Bulk: Using inch tape the measurement is taken 15 cm proximal to the
superior pole of the patella.
b) Quadriceps Hamstrings Index: using Dynamometer
c) Active Knee Range of Motion: Using Goniometer
d) Knee Pain: Using Visual Analog Scale.
e) Electrical muscle activity- EMG surface electrodes
f) Functional activities: Using Lysholm score, 6m hop test
|
1. At Baseline
2. Post-op day 3
3. 2 weeks Post-op
4. 6 months follow-up |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
22/01/2024 |
| 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="2" Months="6" Days="25" |
|
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
|
Persons with anterior cruciate ligament injury (ACL) for whom all inside technique ACLR is planned under Ortho III unit, will be assessed for eligibility and will be included after a written consent by the Principal investigator. Pre-operative assessment will be done, which will include assessment of muscle girth using inch tape, muscle strength using Modified Oxford scale, pain using Visual Analogue Scale (VAS score), active ROM using Goniometer, Quadriceps Hamstring Index (Q/H index), electrical muscle activity of the hamstring muscle using surface EMG electrodes and Functional activities using 3 meter hop test, and Lysholm score. After the initial assessment the subjects will be given a short-term prehab which will include knee strengthening and range of motion exercises, to continue till the day of surgery and the rehabilitation protocol will be explained. (APPENDIX -1) To ensure homogeneity, subjects who have undergone surgery by the same Orthopedic surgeon(Co-investigator) and his team will be recruited. Following surgery, supervised physiotherapy will be given and all the patients will be following the rehabilitation protocol from post-operative day 1(POD 1).
On POD 3, assessment of pain, muscle strength and active knee ROM will be done. Computer generated randomization will be done; sequentially numbered, opaque sealed envelopes (SNOSE) will be used for allocation concealment and the subjects will be randomly allocated to one of the two groups from POD 3. Group I will receive eccentric exercises and Group II will receive concentric exercises for quadriceps strengthening for 2 weeks. In addition, both these groups will be following the exercises of Phase I of the rehabilitation protocol (Phase I: Immediate Post-operative period, 1 to 2 WEEKS). At the end of 2nd week reassessment of pain, muscle girth, muscle strength, active ROM and function will be done. The subjects will be advised to continue the rehabilitation protocol at home. A follow- up assessment will be done at 6 months which will include VAS score, Muscle strength, including Quadriceps Hamstring Index (Q/H index), electrical muscle activity of the hamstring muscle, muscle girth, knee range of motion and knee function. All evaluations will be done by a blinded observer. Analysis will be done to find out the effect of Eccentric exercises versus Concentric exercises in subjects who have undergone ACL Reconstruction. |