| CTRI Number |
CTRI/2024/12/078421 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
20/12/2024 |
| 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 Physiotherapy Intervention On Chronic Ankle Instability |
|
Scientific Title of Study
|
Effect of balance training versus integrated balance with plyometric training on running kinematics among collegiate athletes with chronic ankle instability |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr moazzam Hussain Khan |
| Designation |
assistant professor |
| Affiliation |
jamia millia islamia |
| Address |
Room no 112 first Floor Centre of physiotherapy and rehabilitation scieneces jamia millia islamia Mohammad Ali marg jamia nagar New Delhi 110025 india
South
DElhi
110025
india
South
DELHI
110025
India |
| Phone |
9990307150 |
| Fax |
|
| Email |
mkhan47@jmi.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moazzam Hussain Khan |
| Designation |
Assistant Professor |
| Affiliation |
jamia millia islamia |
| Address |
Room no 112 First Floor Centre for Physiotherapy and Rehabilitation Scieneces Jamia Millia Islamia New Delhi 110025 India
South
DElhi
110025
india
DELHI
110025
India |
| Phone |
9990307150 |
| Fax |
|
| Email |
mkhan47@jmi.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nashra khan |
| Designation |
student |
| Affiliation |
jamia millia islamia |
| Address |
Room no 116 First Floor Centre for Physiotherapy and Rehabilitation Sciences Jamia Millia Islamia Mohammad Ali Marg Jamia Nagar New Delhi 110025 India
South
DELHI
110025
India |
| Phone |
9319280633 |
| Fax |
|
| Email |
nashrakhansiddqui786@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Jamia Millia Islamia |
| Address |
Centre for Physiotherphy and Rehabilitation Sciences Jamia Millia Islamia New Delhi 110025 India |
| Type of Sponsor |
Contract research organization |
|
|
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 Moazzam Hussain khan |
Jamia Millia Islamia |
Centre for
Physiotherapy and
Rehabilitation Sciences
Jamia Millia Islami New Delhi 110025 India South DELHI
South
DELHI |
9990307150
mkhan47@jmi.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, JAMIA MILLIA ISLAMIA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic ankle instability |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
balance training |
3 times per week, for a total of 4 weeks (total 12 session). Duration of training will be 60 min . 7 min aerobic warm up followed by 3 minutes of general stretching exercise s. and every session allow a 2 minutes break in between exercise and then at the last 5 minutes of general stretching for cool down |
| Intervention |
physiotherapy intervention |
balance training combined with plyometric training will be given 3 times per week, for a total of 4 weeks (total 12 session). Duration of training will be 60 min . 7 min aerobic warm up followed by 3 minutes of general stretching exercise s. and every session allow a 2 minutes break in between exercise and then at the last 5 minutes of general stretching for cool down |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
26.00 Year(s) |
| Gender |
Both |
| Details |
All participants had experienced at least one lateral ankle sprain
The initial LAS had occurred more than 12 months before our study began
At least two episode of giving away had occurred within the previous 6 months
Age ranging between 18 to 26 yr
Negative anterior drawer test and talar tilt test
Being able to perform one leg stand with full weight bearing on the injured side atleast three week before the test
All participant scored less than 25 on the Cumberland ankle instability tool
If both ankle were determined to have CAI to prevent unexpected injury during testing less severe side will be chosen
|
|
| ExclusionCriteria |
| Details |
Acute injury of lower extremities within previous 3 months
Previous surgery or fracture in lower 3 months before the study
Visual analogue scale score for pain less than3 by 10 at the ankle while participating in the study Any condition that could affect balance control such as visual vestibular or neurological pathologies
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| modified star excursion balance test, cumberland ankle instability tool, foot lift test , gait on |
at day 0 and at week 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| agility test, 20 m sprint test |
at day 0 and at week 4 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/01/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
All the subjects will be informed about the nature, purpose, and possible risks involved in the study and an informed written consent will be taken from them prior to participation. All the subjects will be selected based on the inclusion criteria. Subjects will be familiarized with all the testing procedures and training prior to the commencement of the study and then an anthropometric evaluation and testing of outcome parameters will be done. The outcome parameters include agility, dynamic balance, speed,and gait kinematics. Then, the subjects will be randomly allocated into one of the two groups as group A and group B in a 1:1 allocation ratio by a computer generated randomization method. Group A will receive balance training combined with plyometric training and group B will receive balance alone. Both the groups will then be analyzed after 4 weeks of training on outcome parameters. |