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CTRI Number  CTRI/2024/05/066742 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 01/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effectiveness of Tennis Ball Foot Exercise on peripheral circulation in lower extremities among elderly Diabetic Patients  
Scientific Title of Study   “Effectiveness of Tennis Ball Foot Exercise on peripheral circulation in lower extremities among elderly Diabetic Patients at selected old age home, Bhubaneswar and Cuttack.’’ 
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 Bhattacharya 
Designation  MSc Nursing 2nd year student 
Affiliation  Kalinga Institute of Nursing Sciences 
Address  Kalinga Institute of Nursing Science kiit University Patia Bhubaneswar
Kalinga Institute of Nursing Sciences kiit University Patia Bhubaneswar
Khordha
ORISSA
751024
India 
Phone  7001465996  
Fax    
Email  ishita97b@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mr. Asokan R 
Designation  HOD Medical Surgical Nursing 
Affiliation  Kalinga Institute of Nursing Sciences 
Address  Kalinga Institute of Nursing Sciences Pradyumna Bal Memorial Hospital Campus -5 Patia Bhubaneswar pin- 751024
kalinga institute of nursing sciences kiit university patia
Khordha
ORISSA
751024
India 
Phone  7008326128  
Fax    
Email  asokan@kins.ac.in  
 
Details of Contact Person
Public Query  
Name  Ishita Bhattacharya 
Designation  MSc Nursing 2nd year student 
Affiliation  Kalinga Institute of Nursing Sciences 
Address  Kalinga Institute of Nursing Sciences Pradyumna Bal Memorial Hospital Bhubaneswar


ORISSA
751024
India 
Phone  7001465996  
Fax    
Email  ishita97b@gmail.com  
 
Source of Monetary or Material Support  
Kalinga Institute of Nursing Sciences 
 
Primary Sponsor  
Name  Self  
Address  Kalinga Institute of Nursing Sciences Pradyumna Bal Memorial Hospital Campus -5 Patia Bhubaneswar orissa pin- 751024 
Type of Sponsor  Other [Kalinga Institute of Nursing Sciences Nursing College] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Asokan R  M P Old Age Home  Rasulgarh Bhubaneswar Odisha 751010
Khordha
ORISSA 		 7008326128

asokan@kins.ac.in 
Prof Asokan R  Nectar Old Age Home   623/934 Mangarajpur Charbatia Choudwar Cuttack
Cuttack
ORISSA 		 7008326128

asokan@kins.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kalinga Institute of Medical Science   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Elder adults diagnosed with diabetes  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  No comparator agent  No comparator agent  
Intervention  Tennis ball foot exercise   It is a Foot exercise using a tennis ball is done to train the leg muscles and foot movement coordination The session of this exercise is for 12 weeks and duration is 30 60 minutes and one session per week The exercise is performed using various steps In this exercise patient will seat on a chair and then practice the gripping motion by putting heel flat on the floor I will put both side of foot on the top of the ball and moving the foot forward and backward and then positioning the ball under both foots individually for practicing right and left shaking motion and then passing of ball from right to left foot and left to right and then put both foot’s heel individually on the ball and practicing circular motion 8 times clockwise and anti clockwise and then stepping on the ball by the heel for bending foot back 8 times  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  Elder diabetic patients who are willing to participate.
Elder diabetic patients of age group from 65 and above.
Elderly diabetic patients without an experience of diabetic foot ulcer.
Elder diabetic patients with an ABI less than 0.9  
 
ExclusionCriteria 
Details  Diabetics with previous amputation and malignancy or acute trauma .
Diabetics with osteomyelitis foot.
Diabetics who will not present during the time of data collection.
Diabetics with previous amputation and malignancy or acute trauma  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of Tennis ball foot exercise on peripheral circulation among elder diabetic patients within 12 weeks  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To reduce risk of poor peripheral blood circulation   30 60 minutes 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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 1 
Date of First Enrollment (India)   18/05/2024 
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="24"
Months="7"
Days="22" 
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 - NO
Brief Summary   Diabetes Mellitus leads to Low Peripheral Circulation in lower extremities can include any disorder that affects any of the blood vessels , it is commonly the disease affecting lower limb .The uncontrolled growth of poor peripheral circulation is already a major public health challenge due to loss of mobility , diminished quality of life and significantly increase the risk for diabetic foot ulcer . Therefore  this study is conducted to assess the efficacy of tennis ball foot exercise on peripheral circulation among elder diabetic patients . Moreover it is a simple and non invasive intervention and it has low cost and safe.This Foot exercise will  provide to elder diabetic patients to improve circulation in lower extremities .This Intervention of the foot exercise by using tennis ball will conduct  for 30- 60 minutes per session/week and this foot exercise program consists of 12 weeks. 

 
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