| CTRI Number |
CTRI/2026/01/102628 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
study on Relationship Between Balance Problems, Thinking Ability that can lead the risk of Falls in Adults with Diabetic Neuropathy |
|
Scientific Title of Study
|
Relationship between proprioceptive deficit, cognitive impairment and fall risk in diabetic 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 |
Rahul M |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement , Department of Physiotherapy, Manipal Hospital, No 98,
Rustam Bagh, Old Airport Road, Bangalore, Karnataka 560017 India
Bangalore
KARNATAKA
560017
India |
| Phone |
9591081228 |
| Fax |
|
| Email |
rahul.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital No. 98, HAL, Old Airport
Road, Bangalore KARNATAKA 560017 India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunima Biswas |
| Designation |
Assistant Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital No. 98, HAL, Old Airport
Road, Bangalore KARNATAKA 560017 India
Bangalore
KARNATAKA
560017
India |
| Phone |
9987194977 |
| Fax |
|
| Email |
arunima.biswas@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL Old Airport Road, Bangalore - 560017 KARNATAKA India |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL Old Airport Road, Bangalore - 560017 KARNATAKA India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Rahul M |
Manipal Hospitals |
Upper Basement Department of Physiotherapy Manipal Hospital No 98 Rustam Bagh Old Airport Road Bangalore Karnataka 560017 India
Bangalore
KARNATAKA |
9591081228
rahul.mhsblr2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional 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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of Type 2 Diabetes Mellitus for more than 5 years
Community-dwelling indiviudals
Ability to understand instructions and ambulate without an assistive device |
|
| ExclusionCriteria |
| Details |
Significant central nervous system dysfunction, musculoskeletal deformity
Lower limb pathologies that affect balance |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proprioception using Biodex Balance System |
Immediate observation only at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cognitive Function using Addenbrooke Cognitive Examination III |
Immediate observation only at baseline |
| Risk of Fall using Falls Efficacy Scale |
Immediate observation only at baseline |
|
|
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)
|
02/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
A more thorough knowledge of the intricate relationship between proprioceptive abnormalities, cognitive impairments, and fall risk in people with DPN is needed. Proprioceptive rehabilitation programs have recently been investigated as possible therapies to address sensory deficiencies and lower fall risk in people with Diabetic Peripheral Neuropathy. However, the combined effect of proprioceptive deficit and cognitive impairment on fall risk is currently underexplored. |