| CTRI Number |
CTRI/2024/01/062133 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
14/06/2024 |
| 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
|
To improve Kabaddi player. Ankle injury Recovery: Customised Exercise Plan for Better Healing. |
|
Scientific Title of Study
|
Improving Ankle Injury Recovery for Kabaddi Athletes: Tailored and Comprehensive Exercise Approach. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Jayalakshmi |
| Designation |
PG SCHOLAR |
| Affiliation |
Amity institute of Health and Allied Sciences |
| Address |
F1 block , department of physiotherapy, Amity University, sector 125, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9650308607 |
| Fax |
|
| Email |
jayulakshmi0@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rabab kaur |
| Designation |
Assistant professor |
| Affiliation |
Amity institute of Health and Allied Sciences |
| Address |
F1 lg23, lower ground floor, F1 block, department of physiotherapy, Amity University sector 125, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
919654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rabab kaur |
| Designation |
Assistant professor |
| Affiliation |
Amity institute of Health and Allied Sciences |
| Address |
F1 lg23, lower ground floor, F1 block, department of physiotherapy, Amity University sector 125, Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
919654478155 |
| Fax |
|
| Email |
rkaur4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity University sector 125, Noida, uttar pradesh |
|
|
Primary Sponsor
|
| Name |
R. Jayalakshmi |
| Address |
F1 block lower ground floor department of physiotherapy Amity University sector 125 Noida |
| 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 Jayalakshmi |
Amity University physiotherapy clinic |
Gate number 1 Amity physiotherapy clinic OPD,Amity University sector 125 Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9650308607
jayulakshmi0@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee Amity institute of Health and Allied Sciences Amity University uttar pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S934||Sprain of ankle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Controlled group |
in controlled group we often provide conventional therapy which includes R.I.C.E: Rest, Ice, Compression & Elevation. Additionally Physiotherapy Exercises that can help strengthen and stabilise the Ankle. |
| Intervention |
Intervention Protocol |
Provide the intervention group with a structured program
of tailored and comprehensive exercise approach for about 4 weeks of intervention. Exercises
might include various balance and proprioception drills with
ankle weight cuffs of appropriate resistance. Ex - Balance
drills , Strengthening exercises,Dynamic movements, proprioception training.
Ensure that exercises are tailored to improve the participants abilities and stage of rehabilitation with different time duration will be given with increased weight every week and at the end will be assessed using the FADI( Foot and Ankle Disability) and ALQS( Athlete Life Quality Scale). |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
20.00 Year(s) |
| Gender |
Both |
| Details |
Age: 15-20 yrs
Gender: Both
Language: Hindi and English
Kabaddi Athletes
Recent Ankle Injury
Willingness to participate
Consent |
|
| ExclusionCriteria |
| Details |
Other Lower Limb Conditions.
Chronic Ankle Injuries.
Any previous or recent Surgeries.
Neurological condition. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain and Ankle Stability. |
Baseline and after 4 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduced Recurrence of Ankle Injuries, Enhanced Range of motion & Balance, with Increased Strength and Flexibility. |
Baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/02/2024 |
| Date of Study Completion (India) |
14/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="28" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
|
The Study addresses the need for Comprehensive Rehabilitation strategies for Kabaddi players with Acute Ankle Sprain . Current approaches lack a holistic focus on both ankle stability and recurrence of Ankle injuries, which are crucial for a complete recovery and preventing future injuries. Kabaddi players have unique demands on their ankles, requiring specialized rehabilitation. Inadequate recovery can lead to lingering instability and increased injury risk. The study explores a novel technique – Balance, Strengthening and ankle weight cuff proprioceptive exercises – aiming to improve recovery and enhance sports medicine practices. Evidence-based insights from the study will guide therapists and players in designing effective recovery plans. The study’s findings may not only aid in injury recovery but also enhance overall athletic performance, offering potential advantages on the field. |