| CTRI Number |
CTRI/2024/03/064614 [Registered on: 21/03/2024] Trial Registered Prospectively |
| Last Modified On: |
21/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To assess the impact of open kinetic chain and closed kinetic chained exercises after ACL reconstruction |
|
Scientific Title of Study
|
To assess the impact of Open kinetic chain and closed kinetic chain exercise in rehabilitation following anterior Cruciate ligament reconstruction |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
V Zephatha |
| Designation |
Post Graduate in Sports Medicine |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
B-Block,Department of sports medicine,Victoria Hospital,BMCRI
Bangalore
KARNATAKA
560018
India |
| Phone |
9383218637 |
| Fax |
|
| Email |
Zephatha45@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dayanand M |
| Designation |
Associate Professor in Sports Medicine |
| Affiliation |
Bangalore medical College and research institute |
| Address |
B block, Department of Sports Medicine,Victoria Hospital,BMCRI
Bangalore
KARNATAKA
560003
India |
| Phone |
9902876934 |
| Fax |
|
| Email |
drdayanand.m@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dayanand M |
| Designation |
Associate Professor in Sports Medicine |
| Affiliation |
Bangalore medical College and research institute |
| Address |
B block,Department of Sports Medicine,Victoria Hospital,BMCRI
Bangalore
KARNATAKA
560003
India |
| Phone |
9902876934 |
| Fax |
|
| Email |
drdayanand.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| KR Road,Bangalore Medical College and Research Institute
56002 |
|
|
Primary Sponsor
|
| Name |
V Zephatha |
| Address |
No115,5th main,4th cross, Nanjamba Agrahara,Chamrajpet |
| Type of Sponsor |
Other [Self] |
|
|
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 V Zephatha |
Bangalore medical college and research Institute |
Room No-24,B block
Department of Sports medicine
Victoria Hospital
560002
Bangalore
KARNATAKA |
9383218637
Zephatha45@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M998||Other biomechanical lesions, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open and closed kinetic chain exercise |
We will assess the pain with VAS score, knee flexion with goniometer, thigh circumference with measuring tape and function with lysholm knee score at 2nd week, 1st month and 3rdmonth |
| Intervention |
Open and Closed kinetic chain exercise in Post ACL reconstruction |
We have to assess the pain, knee flexion,thigh cirvumference and knee function at 2nd week,1st month and 3rd month after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients who undergone ACL reconstruction in Victoria Hospital, BMCRI
Patients Compliant for regular check up |
|
| ExclusionCriteria |
| Details |
Patients with other injury and repair
Postoperative infection
Failure tk follow up |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.pain assessment using visual analog scale
2.active knee flexion using goniometer
3.Thigh circumference using tape
4.knee function using Lysholm knee score |
2nd week, 1st month and 3rd month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Thigh circumference using tape |
2nd week, 1st month and 3rd month |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
25/04/2024 |
| 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="1"
Months="5"
Days="1" |
|
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
|
Anterior cruciate ligament (ACL) injury is one of the most common and serious sport injuries affecting non-professional and professional athletes. Approximately 100,000 ACL Reconstructions are conducted annually in the United States. Also, some authors have documented that the number of the incidence of isolated anterior cruciate ligament (ACL) tears in the general population is not well defined. The treatment of ACL injury can be conservative or arthroscopy reconstruction with post-op rehabilitation depending on the grades of injury. The post-op rehabilitation involves open kinetic chain (OKC) and Close kinetic chain (CKC) exercises. Open kinetic chain (OKC) exercises are lower limb activities where the distal segment of the limb is free to move and primarily focus on isolated strengthening of specific muscles or muscle groups. On the other hand, closed chain exercises involve movements where the distal end of the limb is fixed or in contact with a surface. They mimic functional activities. They have been found to be more effective in restoring quadriceps muscle strength after ACL reconstruction surgery. There is no consensus among the existing published evidence that whether closed kinetic chain (CKC) or open kinetic chain (OKC) exercises should be the intervention of choice following an anterior cruciate ligament (ACL) reconstruction. Many physiotherapists strongly believe that OKC exercises exert greater strain on the ACL and the patellofemoral joint than CKC exercises. But this opinion appears to be based more on opinion than on data. The purpose of the above study is to determine the impact of Open and Closed kinetic chain exercises on post-op rehabilitation of ACL reconstruction. |