| CTRI Number |
CTRI/2024/07/071707 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of jump training exercise and resistance exercise on muscle activity and knee function among badminton players with knee ligament surgery
|
|
Scientific Title of Study
|
Effect of plyometrics and high intensity resistance training on muscle activity and knee function among badminton players with post 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 |
Sumathi M |
| Designation |
Assistant Professor and Research scholar |
| Affiliation |
Vels Institute of Science and Technology and Advanced Studies (VISTAS) |
| Address |
Room number PHY214 School of Physiotherapy Department of orthopedic Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
9940431141 |
| Fax |
|
| Email |
sumathimurugesanmpt7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Senthilselvam |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vels Institute of Science and Technology and Advanced Studies (VISTAS) |
| Address |
Room number PHY214 School of Physiotherapy Department of orthopedic Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
9444309160 |
| Fax |
|
| Email |
hodphysiotherapy@velsuni.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sumathi M |
| Designation |
Assistant Professor and Research scholar |
| Affiliation |
Vels Institute of Science and Technology and Advanced Studies (VISTAS) |
| Address |
Room number PHY214 School of Physiotherapy Department of orthopedic Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai
Chennai
TAMIL NADU
600130
India |
| Phone |
9940431141 |
| Fax |
|
| Email |
sumathimurugesanmpt7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Isari Velan Mission Hospital Thalambur Chennai-600130 |
|
|
Primary Sponsor
|
| Name |
SUMATHI M |
| Address |
Room Number PHY214 School of Physiotherapy Department of orthopaedic Physiotherapy Vels Institute of Science and Technology and Advanced Studies (VISTAS) Thalambur Division Chennai 600130 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sumathi M |
Shri Isari Velan Mission Hospital |
Room number PHY214 School of Physiotherapy Department of Orthopaedic Physiotherapy Thalambur Division Chennai 600130
Chennai
TAMIL NADU |
9940431141
sumathimurugesanmpt7@gmail.com |
| Dr shiden kumar TK |
Shri ishari velan missipn hospital |
OPD room ground floor Thalambur Chennai - 600130
Chennai
TAMIL NADU |
7306371288
dr.shidenkumartk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vels Institute of Science and Technology and Advanced studies school of pharmaceutical sciences institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:Z478||Encounter for other orthopedic aftercare. Ayurveda Condition: no, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | High intensity resistance training | High Intensity resistance training (HIRT) is highly effective in eliciting enhanced neuromuscular activity and skeletal muscle growth and decreases the risk of knee injury
| | 2 | Comparator Arm (Non Ayurveda) | | - | plyometrics | Plyometrics are a type of exercise that uses the stretch-shortening cycle of musculotendinous tissue which uses the energy stored during the eccentric loading phase and stimulation of the muscle spindles to facilitate maximum power production during the concentric phase of movement |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Badminton athletes
non-contact ACL injury.
RSI score greater than 70 percent
Hop test performance score greater than 90 percent
|
|
| ExclusionCriteria |
| Details |
Concomitant surgery limiting an accelerated rehabilitation protocol (meniscal repair or transplant osteotomy micro fracture autologous cartilage implantation or matrix autologous chondrocyte implantation)
Revision surgery Allografts synthetic grafts
Posterolateral, medial or posterior cruciate ligament instability
History of serious ipsilateral or contralateral limb injury
Knee pathology like OA and RA
Athletes with complication after surgery like tunnel malposition patellar fracture infection
ACL injury caused by contact
Lumbar spine pathology or surgery
Non-arthroscopic ACLR
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hop test
|
8 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1RM test |
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 2 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="3"
Months="0"
Days="0" |
|
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
|
This study is randomized controlled parellel group study, Title is "Effect of Plyometrics and High Intensity Resistance Training on muscle activity and knee function among badminton players with post ACL reconstruction" hence one group is receiving plyometrics and the other group is receiving high intensity resistance training with the primary outcome measures of hop tests and EMG
|