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CTRI Number  CTRI/2026/01/102476 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 29/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Better Balance and Smoother Steps Using Agility Training to Improve Life with a Below-the-Knee Prosthetic 
Scientific Title of Study   Effect of agility exercise on balance and gait parameters among unilateral transtibial prosthetic users 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mrs Sowmiya M 
Designation  Physiotherapist  
Affiliation  SRM college of Physiotherapy  
Address  Room no 25 5th floor SRM college of physiotherapy SRM medical college hospital and research center kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  6369290837  
Fax    
Email  sowmiyam1@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Mrs Sowmiya M 
Designation  Physiotherapist  
Affiliation  SRM college of Physiotherapy  
Address  Room no 25 5th floor SRM college of physiotherapy SRM medical college hospital and research center kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  6369290837  
Fax    
Email  sowmiyam1@srmist.edu.in  
 
Details of Contact Person
Public Query  
Name  Aabitha banu 
Designation  Physiotherapist  
Affiliation  SRM college of Physiotherapy  
Address  Room no 25 5th floor SRM college of physiotherapy SRM medical college hospital and research center kattankulathur

Kancheepuram
TAMIL NADU
603203
India 
Phone  7010468402  
Fax    
Email  aabitha18ubaith@gmail.com  
 
Source of Monetary or Material Support  
KARE prosthetics and orthotics 
 
Primary Sponsor  
Name  Aabitha Banu U 
Address  Room no 25 5th floor SRM college of physiotherapy SRM medical college hospital and research center kattankulathur  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aabitha Banu U  KARE Prosthetics and orthotics  old.no 3(new. no. 5) ground floor, Thambuswamy Rd Kilpauk, Chennai Tamil Nadu 600 010
Chennai
TAMIL NADU 		 7010468402

aabitha18ubaith@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M971||Periprosthetic fracture around internal prosthetic knee joint,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Agility ladder exercise, agility drill exercise, weight bearing exercise, weight shifting exercise, balance exercise and gait training   12 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Both men and women
Age between 25 to 45
Only unilateral transtibial amputee using
patella tendon bearing socket
Use of prosthesis for atleast 1 year
Full ROM of hip joint and knee joint
MMT 4 for hip and knee group of muscles
Ability to walk upto 10 meters without any
walking aid
Able to understand the command
 
 
ExclusionCriteria 
Details  Other neurological, orthopaedic and psychiatric conditions Complicated stump( pain, wound) etc.,
Any discomfort or systemic health problems that affect gait, Any psychological or social issues preventing regular participation in the rehabilitation
program 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg balance scale, 4 square step test, gait parameters, kinetic variables using Gait On software  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
step length, stride length, candence  12 weeks 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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)   27/02/2026 
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="15" 
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  

Individuals with a below-the-knee (transtibial) amputation often experience significant instability and an uneven walking rhythm, which increases their risk of falls and makes moving in crowded or uneven spaces difficult. While traditional rehabilitation typically focuses on walking in a straight line, it often lacks the dynamic training needed for real-world activities like turning quickly, stopping suddenly, or navigating around obstacles.

The purpose of this trial is to evaluate the effectiveness of a structured agility exercise program involving rapid changes in direction, side-stepping, and coordination drills in improving balance and gait efficiency among prosthetic users. By training the body and brain to better control the artificial limb during complex movements, this study aims to determine if agility exercises provide a superior way to enhance safety, improve walking symmetry, and build the confidence required for independent daily living.

 
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