| CTRI Number |
CTRI/2024/12/077607 [Registered on: 03/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/12/2024 |
| 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
|
Proprioceptive based exercise program in post knee ACL reconstruction participants |
|
Scientific Title of Study
|
The Impact of Proprioceptive based Exercise program on Agility, muscle strength and dynamic balance among athletes with Post Knee 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 |
Abdul Gayas |
| Designation |
PG Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
07007068540 |
| Fax |
|
| Email |
abdulgayas048@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasobanta Sethi |
| Designation |
Director |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
UTTAR PRADESH
201313
India |
| Phone |
09988600462 |
| Fax |
|
| Email |
jsethi@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
|
|
Primary Sponsor
|
| Name |
Abdul Gayas |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| 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 Jasobanta Sethi |
Amity Institute of Health Allied Sciences |
Department of Physiotherapy
Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9988600462
jsethi@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 |
| Intervention |
Proprioceptive based exercise program |
Proprioceptive based exercises program has been designed to enhance proprioception, which is the bodys ability to sense its position and movement in space without relying on visual input. Proprioception is a critical component of the somatosensory system, relying on sensory receptors located in muscles, tendons, joints, and skin to provide feedback about the bodys position and movement. This feedback helps individuals maintain balance, coordination, posture, and spatial awareness, and is crucial for smooth and efficient movement. This exercise program is criterion based and progression based according to the expected outcome measures , this intervention will be conducted for 6 weeks |
| Comparator Agent |
Rehabilitation Protocol for ACL reconstruction |
This protocol is the post-operative management for ACL Reconstruction. This protocol is
time based (dependent on tissue healing) as well as criterion based. Specific intervention should be based on the needs
of the individual and should consider exam findings and clinical decision making. The timeframes for expected outcomes
contained within this guideline may vary based on surgeon and physiotherapist preference, additional procedures performed, and/or
complications. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
Age: 18-25 years of age
Diagnosis: Post-operative ACL reconstruction (after 4 weeks)
Athletic Background: Actively involved in sports or physical activities prior to injury
Rehabilitation Status: Completed basic rehabilitation protocol (acute phase) and cleared for advanced exercises by the Physiotherapist.
Consent: Giving informed permission to take part in the research.
|
|
| ExclusionCriteria |
| Details |
Additional Injuries: Presence of other significant lower limb injuries or conditions
Medical Conditions: Chronic illnesses or conditions that may affect exercise participation or outcomes (e.g., cardiovascular disease, uncontrolled diabetes)
Surgical Complications: Complications from ACL reconstruction surgery that affect knee function
Non-compliance Risk: Individuals unlikely to adhere to the exercise program or follow-up requirements
Pregnancy: Pregnant women, due to the increased risk and potential need for modifications in exercise
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Agility, muscle strength, dynamic balance |
Baseline, post fourth week, post sixth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/12/2024 |
| 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="0"
Months="3"
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
|
The need of the study is critical due to several reasons, ACL injuries are common in sports that require quick direction changes, and while ACL repair is a routine therapy, the rehabilitation method frequently fails to address proprioception, which is critical for joint stability and coordination. Current rehabilitation protocols prioritize muscle strength and range of motion, Athletes recuperating from anterior cruciate ligament (ACL) repair frequently face major hurdles that might impair their rehabilitation. Muscle strength, agility and dynamic balance are also crucial to full recuperation and avoiding re-injury. Previous studies in India lack in investigating how proprioceptive exercises can precisely enhance these parameters in the context of post-ACL recovery. Addressing this gap could result in more effective, focused rehabilitation programs that improve athletes’ functional results, reduce re-injury risks, and promote their safe return to competitive sports.
Aims: - To Examine the Impact of Proprioceptive based Exercise program on agility, muscle strength and dynamic balance among athletes with Post Knee ACL reconstruction. Objectives: - To find out the effect of the Exercise program based proprioception program on agility among athletes with Post Knee ACL reconstruction. - To find out the effect of the Exercise program based proprioception program on muscle strength among athletes with Post Knee ACL reconstruction. - To find out the effect of the Exercise program based proprioception program on dynamic balance among athletes with Post Knee ACL reconstruction. Hypothesis: Null Hypothesis(H0): H01: There is no significant effect of Proprioceptive based exercise program on agility among athletes with Post Knee ACL reconstruction. H02: There is no significant effect of Proprioceptive based exercise program on muscle strength among athletes with Post Knee ACL reconstruction. H03: There is no significant effect of Proprioceptive based exercise program on dynamic balance among athletes with Post Knee ACL reconstruction. Alternate Hypothesis(H1): H11: There is significant effect of the Exercise program based on proprioception on agility among athletes with Post Knee ACL reconstruction. H12: There is significant effect the Exercise program based on proprioception on muscle strength among athletes with Post Knee ACL reconstruction. H13: There is significant effect the Exercise program based on proprioception on dynamic balance among athletes with Post Knee ACL reconstruction |