| 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
|
|
|
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
|
|
|
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. |