| CTRI Number |
CTRI/2026/03/105280 [Registered on: 03/03/2026] Trial Registered Prospectively |
| Last Modified On: |
02/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Influence of ankle strength, mobility, and fear of falling on foot pressure in diabetic older adults with and without neuropathy |
|
Scientific Title of Study
|
Influence of ankle plantar flexor strength, functional mobility and fear of falling on plantar pressure distribution in diabetic older adults with and without peripheral neuropathy: A cross-sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gauri Sharma PT |
| Designation |
Postgraduate student |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Room no. 21, Department of Physiotherapy, 4, Vishnu Digamber Marg, New Delhi-110002, India
Central
DELHI
110002
India |
| Phone |
9821563305 |
| Fax |
|
| Email |
gaurisharma312@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manda Chauhan PT |
| Designation |
Associate Professor, HOD PT |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Room no. 209, Department of Physiotherapy, 4, Vishnu Digamber Marg, New Delhi-110002, India
Central
DELHI
110002
India |
| Phone |
9911152994 |
| Fax |
|
| Email |
physiotherapypduiph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Marandi PT |
| Designation |
Superintendent Physiotherapist |
| Affiliation |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
Room no. 21, Department of Physiotherapy, 4, Vishnu Digamber Marg, New Delhi-110002, India
Central
DELHI
110002
India |
| Phone |
9818198690 |
| Fax |
|
| Email |
pradeep.marandi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan), 4, Vishnu Digamber Marg, New Delhi - 110002, India |
|
|
Primary Sponsor
|
| Name |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
| Address |
4, Vishnu Digamber Marg, New Delhi-110002 |
| Type of Sponsor |
Other [Rehabilitation and Academic Institute] |
|
|
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 Gauri Sharma PT |
Pt. Deendayal Upadhyaya National Institute for Persons with Physical Disabilities (Divyangjan) |
Room no. 21, Department of Physiotherapy, 4, Vishnu Digamber Marg, New Delhi-110002,India
Central
DELHI |
9821563305
gaurisharma312@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pandit Deendayal Upadhyaya National Institute for Persons with Physical Disabilities |
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, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed with type 2 diabetes for more than or equal to 5 years.
2. HbA1c measured within the past 12 month.
3. Michigan Neuropathy Screening Instrument score for diabetes with DPN group: questionnaire score more than or equal to 4 and physical examination score more than or equal to 2; for diabetes without DPN group: questionnaire score less than 4 and physical examination score less than 2.
4. Able to walk independently. |
|
| ExclusionCriteria |
| Details |
1. Significant neurological conditions unrelated to diabetes.
2. Severe musculoskeletal impairment to lower limb that impact physical performance.
3. Any recent history (last 6 months) of major surgical procedures affecting mobility.
4. Severe cognitive impairment.
5. Use of medications affecting neuromuscular function.
6. Any episode of plantar ulceration.
7. Partial or total amputation.
8. Use of walking aids. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Static plantar pressure distribution
2. Ankle plantar flexor functional strength
3. Functional mobility
4. Fear of falling |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/03/2026 |
| 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 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 cross-sectional study will investigate the influence of ankle plantar flexor functional strength, functional mobility, and fear of falling on static plantar pressure distribution in diabetic older adults with and without diabetic peripheral neuropathy. Diabetic older adults aged 60 to 80 years will be included, and neuropathy status will be determined using the Michigan Neuropathy Screening Instrument. Participants will undergo assessments including the Calf-Raise Senior test, Timed Up and Go test, Falls Efficacy Scale-International, and static plantar pressure distribution using a portable plantar pressure distribution system. Associations among these variables will be analyzed to determine their contribution to plantar pressure abnormalities. Findings are expected to inform targeted physiotherapy interventions aimed at optimizing plantar loading and reducing diabetes-related foot complications. |