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CTRI Number  CTRI/2024/12/077764 [Registered on: 06/12/2024] Trial Registered Prospectively
Last Modified On: 19/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Diagnostic
Screening
Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   To find if Short Term Exercise Programme can have effect on improving balance, Improving Gait, Improving Quality of Life and Improving cardiometabolic parameters in Diabetic Peripheral Neuropathy. 
Scientific Title of Study   Effects of Short Term Exercise Programme on Balance, Gait, Quality of life and Cardiometabolic Parameters in Diabetic Peripheral Neuropathy: Pre and Post Experimental Design 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sonal P Vaigankar 
Designation  Student Ist Year MPT Neurosciences 
Affiliation  Goa Medical College 
Address  Allied Health Science courses Department of Orthopaedics Goa Medical College Bambolim-Goa

North Goa
GOA
403202
India 
Phone  8308736878  
Fax    
Email  sonalvaiganker@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Ms Jorida Fernandes 
Designation  Associate Professor in Physiotherapy  
Affiliation  Goa Medical College 
Address  Department of Orthopaedics Goa Medical College Bambolim-Goa

North Goa
GOA
403202
India 
Phone  9060778888  
Fax    
Email  jorida.fernandes@goa.gov.in  
 
Details of Contact Person
Public Query  
Name  Ms Jorida Fernandes 
Designation  Associate Professor in Physiotherapy  
Affiliation  Goa Medical College 
Address  Department of Orthopaedics Goa Medical College Bambolim-Goa

North Goa
GOA
403202
India 
Phone  9060778888  
Fax    
Email  jorida.fernandes@goa.gov.in  
 
Source of Monetary or Material Support  
Goa Medical College Bambolim-Goa 403202  
 
Primary Sponsor  
Name  Sonal P. Vaigankar 
Address  Allied Health Science courses Department of Orthopaedics Goa Medical College Bambolim-Goa  
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 
Sonal P Vaigankar  Goa Medical College Hospital  Medicine Department wards: 144, 142 (third floor) 145, 147(fourth floor)
North Goa
GOA 		 8308736878

sonalvaiganker@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications, (2) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications, (3) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Closed kinematic chain exercise  An intervention period which will be tailored made based is set for 3week with 5 sessions per week with total 15 sessions these exercises will be performed on firm surface.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Participants of all gender with age between 40-65yrs visiting GMC
2.Participants with DPN with type 2 DM with score of atleast 3 or more as per DNE screening criteria
3.Participants with normal ROM of wrist, knees, hips and ability to stand, walk independently without assistive devices
 
 
ExclusionCriteria 
Details  1.Participants with foot ulcer and lower limb deformity
2.History of chronic pain or surgery in lower leg or back
3.Systemic conditions (hypotension, Head injury or stroke)
4.Musculoskeletal injuries (fragility fractures, traumatic fractures) or disease(osteopenia)
5.Nervous system diseases (non-diabetic neuropathy (e.g. as indicated by vitamin B12 deficiency, Guillain-Barré syndrome, car accident, sporting injury, falling, work injury, or surgery, tumor can compress, pinch or even sever the nerve.)
6.On medications other than BP, glucose and lipid control so that balance would not be affected.
7.Pulmonary conditions like (chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, pneumonia, and lung cancer) having symptoms of chest pain and breathlessness
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the differnce between baseline and follow-up scores of Berg balance scale, Time up and go test (TUGT), walking speed Rand SF36 scale and cardiometabolic parameters  Single group will be assesed before and after 3 week intervention for balance, gait, quality of life and cardiometabolic parameters 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   20/12/2024 
Date of Study Completion (India) 01/11/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 01/11/2025 
Estimated Duration of Trial   Years="1"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sonalvaiganker@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-01-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This study evaluated a 3-week short term exercise programe effects on balance, gait, quality of life, and cardiometabolic parameters in 30 individuals with diabetic peripheral neuropathy. Assessments included the Berg Balance Scale, Time Up and Go Test, walking speed, Rand SF36 scale, and measures of fasting plasma glucose, HDL-C, LDL-C, and total cholesterol. Outcomes measures was compared pre- and post-intervention to determine the programs impact of balance, gait, quality of life and cardiometabolic parameters.
short-term exercise program produced significant improvements in metabolic, balance, and functional parameters in DPN patients. 
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