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CTRI Number  CTRI/2025/07/091526 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 20/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between physical activity and Endurance in people with below knee leg loss of one leg because of Diabetes Mellitus 
Scientific Title of Study   Association between physical activity and Aerobic capacity in individuals with Unilateral transtibial amputation Secondary to diabetes mellitus in pre Prosthetic phase.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aaditee Yadav 
Designation  student 
Affiliation  ALL INDIA INSTITUTE OF PHYSICAL MEDICINE AND REHABILITATION,HAJI ALI 
Address  Room 204,2nd floor,Physiotherapy department,All India Institute of Physical Medicine and Rehabilitation,Mumbai.KK Khadye marg,Hajiali,Mumbai.
Room 204,2nd floor,Physiotherapy department,All India Institute of Physical Medicine and Rehabilitation,Mumbai.KK Khadye marg,Hajiali,Mumbai.
Mumbai
MAHARASHTRA
400034
India 
Phone  7977420980  
Fax    
Email  draaditeephysio@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SNEHA SARVANAKUMAR 
Designation  LECTURER 
Affiliation  ALL INDIA INSTITUTE OF PHYSICAL MEDICINEAND REHABILITATION,MUMBAI 
Address  Room 204,2nd floor,Physiotherapy department,All India Institute of Physical Medicine and Rehabilitation,Mumbai.KK Khadye marg,Hajiali,Mumbai.
Room 204,2nd floor,Physiotherapy department,All India Institute of Physical Medicine and Rehabilitation,Mumbai.KK Khadye marg,Hajiali,Mumbai.
Mumbai
MAHARASHTRA
400034
India 
Phone  9833493029  
Fax    
Email  snehas.pt@aiipmr.gov.in  
 
Details of Contact Person
Public Query  
Name  Aaditee Yadav 
Designation  Student 
Affiliation  ALL INDIA INSTITUTE OF PHYSICAL MEDICINE AND REHABILITATION MUMBAI 
Address  Room 204,2nd floor,Physiotherapy department,All India Institute of Physical Medicine and Rehabilitation,Mumbai.KK Khadye marg,Hajiali,Mumbai.
Room 204,2nd floor,Physiotherapy department,All India Institute of Physical Medicine and Rehabilitation,Mumbai.KK Khadye marg,Hajiali,Mumbai.
Mumbai
MAHARASHTRA
400034
India 
Phone  7977420980  
Fax    
Email  draaditeeohysio@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Physical Medicine and Rehabilitation,Mumbai-400034,Maharashtra,India 
 
Primary Sponsor  
Name  Aaditee Yadav 
Address  All India Institute of Physical Medicine and Rehabilitation,KK Khadye Marge,Mumbai 400034  
Type of Sponsor  Other [] 
 
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 AADITEE YADAV  ALL INDIA INSTITUTE OF PHYSICAL MEDICINE AND REHABILITATION  ROOM 204,DEPARTMENT OF PHYSIOTHERPAY,AIIPMR,MUMBAI
Mumbai
MAHARASHTRA 		 7977429080

draaditeephysio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE,AIIPMR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E105||Type 1 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Day(s)
Age To  60.00 Day(s)
Gender  Both 
Details  INDIVIDUALS WHO HAS UNDERGONE UNILATERAL TRANSTIBIAL AMPUTATION SECONDARY TO TYPE 2 DIABETES MELLITUS.
INDIVIDUALS IN PRE PROSTHETIC PHASE.
INDIVIDUALS OF FUNCTIONAL LEVEL K2-K4 OF MEDICARE FUNCTIONAL CLASSIFICATION SCREENED BY AMPUTEE MOBILITY PREDICTOR 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.VO2 max using the 6-minute walk test.
 		 1.Number of steps in a day using Pedometer.  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="29"
Sample Size from India="29" 
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)   13/08/2025 
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   Diabetes has made its mark in the community, as its prevalence is four times higher than all cancers. With the increase in life expectancies, it has contributed significantly to the exponential rise, it now contributes to global mortality.Diabetes can lead to several severe pathophysiological changes such as ischemia, deformities, neuropathy, disturbed muscle balance and their functions, malposition, loss of mobility and sensitivity, nonhealing open wound, ulcer, or a combination of all especially at distal end of leg i.e the foot has the ability to the process of amputation.The goal of treatment for diabetic patients is to facilitate a tailormade treatment plan.To improve hyperglycemic levels, to improve health, to improve quality of life, to prevent further complications and premature mortality, engaging in physical activity & behaviors is a key component.If failed to comply by the above-mentioned measures for hyperglymic control,it may lead to amputation.A lower limb amputation leads to reduced mobility, and the performance of activities of daily living is hampered.This limitation of the function and structure of the body impacts the quality of life.reduced functional mobility leads to decreased cardiovascular endurance and a higher prevalence of depression, as individuals with lower limb amputation are often confined to their homes and may adopt either a low-active or sedentary lifestyle and may lead to more energy expenditure. This results in decreased cardiovascular fitness, weight gain, uncontrolled glycemic levels,vulnerability to another amputation, Reduced quality of life and an increased fear of falling. This may in turn further hinder gait training after the procurement of a prosthesis.Thus it would be of interest to assess physical activity and aerobic capacity in individuals with unilateral transtibial amputation in the preprosthetic phase and observe how each relates to the other.
Methodology-The Study design is Cross Sectional observational studywith Study setting in Teritary care setting and Rehabilitation center of duration 6 Months and Sampling methodwill be Convenience sampling with a sample size of 29.Those who will give informed consent will be screened for inclusion and exclusion criteria, and those who will fulfill the criteria will be included in the study as per voluntary enrolment. To assess physical activity, subjects will be assessed by the number of steps for which a Pedometer will be utilized. Average of three days will be noted.To assess aerobic capacity, 6-minute walk test will be used.
Statistical Analysis-The normality of data will be assessed using the Shapiro-Wilk test. A p value of less than < 0.05 will be considered statistically significant.If data passes normality test,Pearsons correlation coefficient test will be used.If data doesn’t pass the normality test,Spearmans correlation correlation test will be used.


 
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