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CTRI Number  CTRI/2024/05/067744 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 21/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Association Between Plantar Pressure and Fall Risk in Patients with Diabetic Neuropathy 
Scientific Title of Study   Association Between Plantar Pressure and Fall Risk in Patients with Diabetic Neuropathy: An Observation 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  Brahmi 
Designation  Post graduate student 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy, Room Number 20, Second base division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  7676359077  
Fax    
Email  aithal.brahmi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Krishna Prasad K M 
Designation  Assistant Professor, G I 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy, Room Number 20, Second base division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8301061501  
Fax    
Email  krinshnapr@nitte.edu.in  
 
Details of Contact Person
Public Query  
Name  Krishna Prasad K M 
Designation  Assistant Professor, G I 
Affiliation  Nitte Institute of Physiotherapy 
Address  Department of Physiotherapy, Room Number 20, Second base division, Nitte Institute of Physiotherapy, NITTE(Deemed to be University), Deralakatte, Mangaluru, Karnataka, India

Dakshina Kannada
KARNATAKA
575018
India 
Phone  8301061501  
Fax    
Email  krinshnapr@nitte.edu.in  
 
Source of Monetary or Material Support  
Nitte Institute of Physiotherapy  
 
Primary Sponsor  
Name  Nitte Institute of Physiotherapy NITTEDeemed To be University 
Address  Nitte Institute of Physiotherapy, NITTE Deemed to be University, Nithyananda Nagar, Deralakatte,Mangaluru, Dakshina Kannada, Karnataka-575018,India 
Type of Sponsor  Other [ Nitte Institute of Physiotherapy, NITTE(Deemed To be University)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishna Prasad K M  Justice K S Hegde Charitable Hospital  Department no.10, Department of general medicine, medical Science complex, Deralakatte, Mangaluru - 575018
Dakshina Kannada
KARNATAKA 		 8301061501

krinshnapr@nitte.edu.in 
Dr Krishna Prasad K M  Justice K S Hegde Charitable Hospital  Department no.15, Department of general surgery, medical science complex, Deralakatte, Mangaluru-575018
Dakshina Kannada
KARNATAKA 		 8301061501

krinshnapr@nitte.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Nitte Institute of Physiotherapy  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 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  35.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. People diagnosed with Diabetic Neuropathy
2. People able to stand on both feet
3. People without foot ulcers
4. 10g Monofilament test ranging from 1.65 – 6.65 
 
ExclusionCriteria 
Details  1. Neurological disorders which affect balance and cognition
2. People with foot cons
3. Diabetic foot ulcers
4. Amputated lower limbs
5. Recent lower limb surgery past 6 months
6. Recent fractures of lower limb past 6 months
7. Recent falls within 6 months 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Plantar pressure analysis system
2. TUG test
3. ABC-16 scale 		 Assessment will be taken once at the beginning of the study 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2024 
Date of Study Completion (India) 06/01/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   Diabetes mellitus (DM) is the collective term with main symptom of chronic hyperglycemia leading to one of the most important complication-Diabetic neuropathy. Diabetic patients with neuropathy are at high risk for the development of ulcers which might lead to falls due to high plantar pressure and sensory loss. Typically, in terms of diabetic neuropathy population, it is important to assess the factors that might cause falls in this population. As these populations are more prone to falls, factors responsible for falls should be identified. Physiotherapists who are qualified to prescribe exercise should know these factors with the goal of preventing falls. Additionally, comprehending the fall risk among the diabetic population is essential for conducting successful fall prevention programs and might aid in knowledge transfer to other developing nations. There is a dearth of studies that compare plantar pressure and fall risk in diabetic neuropathy patients in large populations between TUG and PP, using plantar pressure force systems (portable and wireless), especially in the Indian population. Hence, this study aims to find the association between plantar pressure and fall risk in diabetic neuropathy patients leading to falls. The result of the study will be useful for the therapist to rehabilitate and educate the patient about the fall risk and how to prevent it. In addition, these assessment methods are cost effective and portable which benefits the patient and the therapist.   
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