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CTRI Number  CTRI/2025/07/090069 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   How foot shape affects balance in people with diabetic nerve damage  
Scientific Title of Study   Association between foot indices and balance in diabetic peripheral neuropathy  
Trial Acronym  Nil  
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Farha Fathima M F  
Designation  Student  
Affiliation  Alva’s College of Physiotherapy and Research centre  
Address  Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri, Karnataka
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri, Karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  6366590210  
Fax    
Email  farha.f2001@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Hariharasudhan Ravichandran 
Designation  Professor 
Affiliation  Alva’s College of Physiotherapy and Research Centre  
Address  Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri, Karnataka
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri, Karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9789906015  
Fax    
Email  hrkums63@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Hariharasudhan Ravichandran 
Designation  Professor 
Affiliation  Alva’s college of Physiotherapy and Research Centre  
Address  Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri, Karnataka
Out Patient Department, Department of Physiotherapy, Alvas Health Centre, Alvas Health Centre Complex, Alvas Health Centre Road, Mudbidri, Karnataka
Dakshina Kannada
KARNATAKA
574227
India 
Phone  9789906015  
Fax    
Email  hrkums63@gmail.com   
 
Source of Monetary or Material Support  
Alva’s college of Physiotherapy and Research centre Out patient department Alvas Health centre complex Mudbidri Karnataka 574227 Monofilament  
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Farha Fathima M F   Alva’s College of Physiotherapy and Resarch Centre   Out patient department, department of physiotherapy, Alvas health centre, Alvas health centre complex,Alvas health centre road Mudbidri
Dakshina Kannada
KARNATAKA 
6366590210

Farha.f2001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Alvas College of Physiotherapy Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diabetic individuals with and without DPN diagnosis;
Diagnosis of DPN by Nerve conduction study;
Ability to walk independently;
Willingness to provide informed consent;
 
 
ExclusionCriteria 
Details  History of lower limb amputation or major foot deformity unrelated to DPN;
Neurological disorders;
vestibular disorders;
musculoskeletal conditions that affect balance and mobility example Parkinsons disease stroke dizziness fractures acute osteoarthritis
Severe visual impairment ;
Active foot ulcers or infections ;
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Bergs Balance Scale
Single leg stance  
Baseline and immediately after performance of the test. 
 
Secondary Outcome  
Outcome  TimePoints 
Foot Indices.
 
Baseline and immediately after performance of the test. 
Monofilament test  Baseline and immediately after the performance of the test. 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   20/07/2025 
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="8"
Days="0" 
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   This research explores the association between foot structure and balance in individuals with and without diabetic peripheral neuropathy(DPN), a common and serious complication of type 2 diabetes. DPN results from prolonged hyperglycaemia, leading to nerve damage, sensory deficits, muscle weakness, and compromised postural control. These effects increase the risk of falls, ulcers and amputations significantly impacting the quality of life. 
The study is driven by the hypothesis that changes in foot morphology, measured by foot indices such as the Staheli Index, Chippaux-Smirak Indexand Clarke’s angle, Harris imprint Index, Arch Index may be linked to balance impairments in DPN patients. It also investigates whether balance deficits are primarily due to neuropathy or if altered foot structure plays an independent role. Using validated tools like Berg Balance Scale(BBS) and Single Leg Stance (SLS) test, balance performance is assessed alongside foot arch evaluation and sensory testing with monofilaments. 
The study adopts a cross-sectional design involving 54 participants aged greater than or equal to 50 years, equally divided into DPN AND non - DPN groups, recruited from hospitals and clinics in Dakshina Kannada. Inclusion and Exclusion criteria ensure accurate diagnosis and control of confounding conditions.Data is collected on demographics, diabetic history, foot structure, sensory response and balance. 
Statistical analysis involves correlating foot indices with balance measure to determine significant relationships. The study aims to identify early predictors of balance dysfunction to inform preventive and personalised physiotherapy interventions. 
By addressing a gap in existing literature, this research highlights the importance of early detection of biomechanics foot changes and their impact on functional stability in diabetic populations. Ultimately, the findings aim to contribute to fall prevention strategies, reduce healthcare costs, and improve patient outcomes through targeted rehabilitation focused on both sensory and structural foot health.
 
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