| CTRI Number |
CTRI/2025/01/079178 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| 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
|
Core stability exercises for Knee Strength, Function and Dynamic Balance in athletes. |
|
Scientific Title of Study
|
Efficacy of Core Stability Training Program with Conventional Training on Knee Strength, Function and Dynamic Balance in Athletes with ACL Reconstruction and Partial Meniscectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ishita Arora |
| 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
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8810339100 |
| Fax |
|
| Email |
ishita25arora@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor Grade III |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anu Bansal |
| Designation |
Assistant Professor Grade III |
| 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
201313
India |
| Phone |
9999620738 |
| Fax |
|
| Email |
abansal@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 201313, India |
|
|
Primary Sponsor
|
| Name |
Ishita Arora |
| Address |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125 Noida, Uttar Pradesh 201313, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Anu Bansal |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125, Noida, Uttar Pradesh 201313 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ishita Arora |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University F1 LGF Sector 125, Noida, Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH |
8810339100
ishita25arora@gmail.com |
|
|
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 F1 LGF Sector 125, Noida, Uttar Pradesh 201313 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S838||Sprain of other specified parts ofknee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Training Protocol |
Those subject who have achieved complete knee range of motion post ACL reconstruction and partial meniscectomy will be included in the study protocol.Patients who meet the above criteria will then be explained about the 6 weeks protocol of conventional training and informed consent will be taken. Those who will provide the consent will then be assessed for the outcome measures i.e. Knee strength, knee function and dynamic balance. Then six weeks protocol including conventional training will be administered to these patients. After completion of six weeks of conventional training, patients will be reassessed for the outcome measures i.e. knee strength, knee function and dynamic balance. |
| Intervention |
Core Stability Training Program with Conventional Training |
Those subject who have achieved complete knee range of motion post ACL reconstruction and partial meniscectomy will be included in the study protocol.Patients who meet the above criteria will then be explained about the 6 weeks protocol of conventional training along with core stability training and informed consent will be taken. Those who will provide the consent will then be assessed for the outcome measures i.e. Knee strength, knee function and dynamic balance. Then six weeks protocol including conventional training along with core stability training will be administered to these patients. After completion of six weeks of conventional training along with core stability training, patients will be reassessed for the outcome measures i.e. knee strength, knee function and dynamic balance. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals (both males and females) must be involved in sports (athletes).
2. Individuals between 20-35 years of age.
3. Individuals are free from any cardiorespiratory illness.
4. Individuals able to comprehend commands and ready to participate in this study.
5. Individuals must have undergone ACL Reconstruction and partial meniscectomy.
|
|
| ExclusionCriteria |
| Details |
1. Individuals who are taking any kind of pharmacological agent at the time of the study that can improve efficacy.
2. Sports person with injury to structures of the knee other than ACL and meniscus and got surgical managements other than ACL reconstruction and partial meniscectomy.
3. Individuals who have undergone any revision surgeries /previous surgeries at the knee joint.
4. Individuals with any neurological or musculoskeletal impairments(other than ACL Reconstruction and Partial Meniscectomy).
5.Athletes having any visual/cognitive/sensory impairments.
6. Local post op infection at the site of surgery. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dynamic Balance
Knee Strength
Knee Function |
Baseline, 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/01/2025 |
| 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="5"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ishita25arora@gmail.com].
- For how long will this data be available start date provided 11-01-2025 and end date provided 11-05-2025?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Aims and Objectives-
Aim: To determine the relative effects of core stability training program with conventional training on Knee Strength, Function and Dynamic Balance in athletes with ACL Reconstruction and Partial Meniscectomy.
Objectives: 1. To determine the effects of Core Stability Training Program on Isokinetic Knee Strength in athletes with ACL Reconstruction and Partial Meniscectomy. 2. To determine the effects of Core Stability Training Program on Knee Function in athletes with ACL Reconstruction and Partial Meniscectomy. 3. To determine the effects of Core Stability Training Program on Dynamic Balance in athletes with ACL Reconstruction and Partial Meniscectomy.
|