| CTRI Number |
CTRI/2025/08/092731 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| 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
|
Improving Knee Stability in Athletes After ACL Injury Through Proprioceptive and Plyometric Training |
|
Scientific Title of Study
|
Effectiveness of Proprioceptive and Plyometric Training on Joint Stability in Athletes Following ACL Injury |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mamun Mahmud |
| Designation |
Post-graduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore- 7408, Bangladesh.
7408 Other |
| Phone |
8801882481631 |
| Fax |
|
| Email |
mahmudmamun812@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mamun Mahmud |
| Designation |
Post-graduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore- 7408, Bangladesh.
7408 Other |
| Phone |
8801882481631 |
| Fax |
|
| Email |
mahmudmamun812@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Zahid Hossain |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room No 302, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore- 7408, Bangladesh.
7408 Other |
| Phone |
880101670962775 |
| Fax |
|
| Email |
mz.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of
Science and Technology (JUST), Jashore-7408, Bangladesh. |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room No 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh. |
| Type of Sponsor |
Other [University of Science and Technology (JUST), Jashore-7408, Bangladesh.] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr. M R Khan Medical Center, Jashore University of Science and Technology, Jashore-7408, Bangladesh. |
Room no: 306, 2nd floor, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408, Bangladesh.
|
8801778315139
mkb.hossain@just.edu.bd |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of Department of Physiotherapy and Rehabilitation, JUST |
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 |
| Intervention |
1. Proprioception Training: for 30 minutes
2. Plyometric Training: for 30 minutes |
Proprioception Training: for 30 minutes
1. Single-stance balance exercise performed on: a stable surface, an unstable surface (foam), and an unstable surface (wobble board) with open eyes and closed eyes.
2. Single-stance balance exercise throws the ball in different directions on a stable and unstable surface.
3. Single-stance balance exercise proprioceptive neuromuscular facilitation (PNF) with TheraBand.
4. Single-leg cone pick-up
5. Single-leg balance with ball toss
Plyometric Training: for 30 minutes.
1. Standing vertical hops 2 sets, 8 reps.
2. Counter movement jump (CMJ) 2 sets, 8 reps.
3. Depth jumps 2 sets, 8 reps.
4. Multiple two-foot hurdle jumps (hurdle height 0.55m) 2sets, 8 reps.
5. Two-foot jumps forward and backward 2 sets, 8 reps.
6. Single foot jumps 3 sets, 10 reps.
7. Lateral two-foot jumps 3 sets, 10 reps.
For 8 weeks. |
| Comparator Agent |
Conventional therapy |
1. Passive ROM, Patellar mobilization for 5 minutes.
2. Hamstring, quadriceps, calf, hip flexor stretches exercise for 10 minutes and 3 reps, 30 sec, 15 sec rest.
3. Isometric quads 5 minutes and 10 reps, 3sets, 10 sec hold, 15 sec rest.
4. Hamstring curls for 5 minutes and 10 reps, 3sets,15 sec rest.
5. Heel slides for 5 minutes and 10 reps x 3 sets, 2 hold
6. Bridging with double or single leg for 15 minutes and 10 reps x 3 sets, 5 sec hold, 5 sec rest.
7. Closed-chain exercises (mini squats) for 5 minutes and 10 reps x 2 sets, 5 sec rest.
8. Sit-to-stand for 5 minutes and 10 reps x 3 sets, 5 sec rest.
9. Step-ups for 5 minutes and 10 reps x 3 sets, 5 sec rest.
For 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Athletes aged 18-35 years.
2. Both male and female athletes.
3. Unilateral ACL injury or ACL reconstruction.
4. No history or signs of injury in the contralateral knee.
5. Knee ROM greater than 100° flexion and complete extension.
6. Willing to participate in the intervention and follow-up testing as outlined in the protocol.
7. BMI is 30 or less. |
|
| ExclusionCriteria |
| Details |
1. Athletes with a history of muscle or joint injuries.
2. Athletes who had already followed a pre-operative rehabilitation program.
3. Athletes with complications after surgery.
4. Pregnant athletes and those who were taking anti-inflammatory drugs or muscle relaxers were also excluded.
5. Open wound, any active infection, and incontinence during exercise.
6. Usage of opioid analgesics or systemic corticosteroids within the last four weeks.
7. Inability to do exercise.
8. Unwillingness to participate in the study.
9. Engagement in out-of-schedule exercises. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Joint Stability: Star Excursion Balance Test (SEBT) |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Functional Score: IKDC or KOOS questionnaire
Pain: Visual Analog Scale (VAS)
Return to sport readiness: ACL-Return to Sport after Injury (ACL-RSI) scale |
2 Months |
|
|
Target Sample Size
|
Total Sample Size="62" Sample Size from India="0"
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)
|
20/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mahmudmamun812@gmail.com].
- For how long will this data be available start date provided 02-07-2025 and end date provided 02-07-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effectiveness of combined proprioceptive and plyometric training on joint stability in athletes following anterior cruciate ligament (ACL) injury. A total of 62 athletes aged 18 to 35 years with unilateral ACL injury or post-ACL reconstruction will be randomly allocated into two groups. The experimental group will receive proprioceptive and plyometric training for 60 minutes per session in addition to conventional therapy, while the control group will receive only conventional physiotherapy. The proprioceptive training includes single-leg balance exercises on stable and unstable surfaces, ball toss, PNF with resistance band, cone pick-up, and dynamic balance tasks. Plyometric exercises include vertical hops, counter movement jumps, depth jumps, two-foot and single-foot hurdle and directional jumps. The control group will receive range of motion, stretching, isometric and closed-chain strengthening exercises, gait training, and functional tasks such as sit-to-stand and step-ups. The intervention will be delivered over 6 weeks. The primary outcome is joint stability, measured using the Star Excursion Balance Test (SEBT). Secondary outcomes include knee function (IKDC or KOOS questionnaire), pain (Visual Analog Scale), and psychological readiness to return to sport (ACL-RSI scale). The findings will help inform evidence-based rehabilitation practices for athletes recovering from ACL injury. |