| CTRI Number |
CTRI/2024/12/078401 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| 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
|
Additional effects of core muscle training in recovery after ACL reconstruction surgery. |
|
Scientific Title of Study
|
Effect of neuromuscular training with core exercises on dynamic stability of athletes with ACL 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 |
VIBHOR KUMAR SINGH |
| Designation |
Post Graduation Student |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Allied Health Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
7209526008 |
| Fax |
|
| Email |
vksinghphysio22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pankaj Kumar Malik |
| Designation |
Assistant Professor III |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Allied Health Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9899274238 |
| Fax |
|
| Email |
pkmalik@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pankaj Kumar Malik |
| Designation |
Assistant Professor III |
| Affiliation |
Amity Institute of Health and Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Allied Health Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9899274238 |
| Fax |
|
| Email |
pkmalik@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Uttar Pradesh, 201301 |
|
|
Primary Sponsor
|
| Name |
Vibhor Kumar Singh |
| Address |
Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Noida, Uttar Pradesh, 201301 |
| 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 Pankaj Kumar Malik |
Amity Institute of Allied Health and Sciences |
Department of
Physiotherapy, Amity
Institute of Health Allied
Sciences, Amity
University, F1 LGF,
Sector 125, Noida, Uttar
Pradesh, Gautam Buddha Nagar,
UTTAR PRADESH, 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9899274238
pkmalik@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy,Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S835||Sprain of cruciate ligament of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Neuromuscular training with Core stability exercises |
In this protocol, a combination of both neuromuscular training and core stability-based exercises has been designed for the athletes having ACL reconstruction surgery to evaluate their dynamic balance.Protocol will be given for six weeks. |
| Intervention |
Neuromuscular training-based exercise protocol |
Neuromuscular training has been designed for the athletes having ACL reconstruction surgery to evaluate their dynamic balance.
The total duration of the intervention will be of six weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Individuals with a unilateral ACL injury who underwent surgery two months ago (or more) to reconstruct the ACL using a hamstring graft and who immediately got physical therapy to help with edema reduction and range of motion. Tier 2 and Tier 3 athletes. Have 70-80% or more score in SAS(Knee Outcome Survey Sports Activities Scale)
|
|
| ExclusionCriteria |
| Details |
Patients with a history of complex knee surgery. Non-operative therapy. Bilateral or partial ACL damage. Ligament-related pathology that needed to be treated surgically during the index procedure. Revision of ACL reconstruction. Grade III or IV chondral injury to the outer bridge. Recent re-injury within a month, and people with additional conditions like cancer, arthritis, bleeding disorders, organic referral pain, or pregnancy. Other than hamstring grafts used for ACL reconstruction. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dynamic stability, Strength, |
Baseline, second week, fourth week, sixth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Core muscles endurance |
Baseline, post second week, post fourth week, post sixth week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/12/2024 |
| Date of Study Completion (India) |
29/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
Participants will be selected for the study on the basis of inclusion and exclusion criteria. Before the intervention, participants will get information about the study and complete a consent form. Individuals will be randomly assigned to their groups: Group A (experimental) and Group B (control). Group A (Experimental Group) will receive NMT in combination with core exercise related to dynamic stability after ACL reconstruction. Group B (Control Group) will receive NMT. Participants will undergo a pre-assessment prior to the intervention, and after the eight-week intervention, assessments will be conducted in the second, fourth, sixth, and eighth weeks. |