FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/07/091197 [Registered on: 18/07/2025] Trial Registered Prospectively
Last Modified On: 17/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   The Impact of Diabetic Peripheral Sensory Dysfunction on Mobility Gait Walking Speed and Balance Performance 
Scientific Title of Study   Quantifying The Impact Of Diabetic Peripheral Sensory Dysfunction On Neural Mobility Gait Speed And Balance Performance 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amratha G Shetty 
Designation  Asso Prof 
Affiliation  ALVAS COLLEGE OF PHYSIOTHERAPY 
Address  Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada

Dakshina Kannada
KARNATAKA
574227
India 
Phone  9591593863  
Fax    
Email  amrathagshetty@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Shreya Bhandari 
Designation  Post Graduate 
Affiliation  ALVAS COLLEGE OF PHYSIOTHERAPY 
Address  Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8147069080  
Fax    
Email  shreyabhandari75@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Shreya Bhandari 
Designation  Post Graduate 
Affiliation  ALVAS COLLEGE OF PHYSIOTHERAPY 
Address  Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada

Dakshina Kannada
KARNATAKA
574227
India 
Phone  8147069080  
Fax    
Email  shreyabhandari75@gmail.com  
 
Source of Monetary or Material Support  
Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada Monofilament, Aesthesiometer, Foam pad 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [] 
 
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 Shreya Bhandari  Alvas Health Center  Out Patient Department, Department Of Physiotherapy, Alvas Health Center Complex, Alvas Health Center Road Mudbidri Karnataka Dakshina Kannada
Dakshina Kannada
KARNATAKA 
08147069080

shreyabhandari75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ALVAS COLLEGE OF PHYSIOTHERAPY ETHICS COMMITEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Individuals having type 2 diabetes more than 3 years and less than 10 year;Individuals with undetected peripheral neuropathy(DPN);Consent to participate in the study;Able to walk without assistive device 
 
ExclusionCriteria 
Details  Previously diagnosed Diabetic neuropathy; Any other neurological disease causing neuropathy or cardiovascular disorders; Any low back related condition causing nerve deficit; Hypomobile or hypermobile lower limb joints; Open foot ulcers or wound; Congenital or acquired deformities of lower limb; Recurrent dizziness and vertigo; History of amputation; Unwilling to participate in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Two-point discrimination test useing aesthesiometer
Semmes Weinstein monofilament testing
10 Meter Walk test
Balance Error Scoring System
Neural Mobility test –Tibial nerve and Sural nerve Mobility test
 
After recruitment
Time point 0-Two point discrimination
Time point 1-Monofilament testing
Time point 2- 10 Meter walk test
Time point 3- BESS
Time point 4- Neural mobility test
T0-5min,T1-5min,T2-10min,T3-10min,T4-5min 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   23/08/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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  

The study titled "Quantifying the Impact of Diabetic Peripheral Sensory Dysfunction on Neural Mobility, Gait Speed, and Balance Performance" aims to explore how sensory impairments associated with Type 2 Diabetes Mellitus (T2DM) affect physical performance and neural function. Diabetes mellitus is known to cause long-term complications, particularly affecting the nervous system, resulting in peripheral diabetic neuropathy (PDN) in 30–50% of patients. These complications manifest as sensory and motor dysfunctions such as reduced tactile discrimination, altered proprioception, muscle weakness, and impaired gait and balance. The study employs a cross-sectional design with 62 participants diagnosed with T2DM for more than two years but without clinically diagnosed DPN. Participants will undergo a series of assessments including two-point discrimination using an aesthesiometer, Semmes Weinstein monofilament testing for foot sensitivity, a 10-meter walk test for gait speed, neural mobility tests focusing on the tibial and sural nerves, and the Balance Error Scoring System (BESS) for balance evaluation. These measures will help establish correlations between sensory loss and functional impairments in mobility and balance. The study’s significance lies in identifying early sensory deficits that could potentially lead to falls and decreased quality of life, even before full-blown DPN manifests. A detailed review of literature supports the hypothesis that sensory dysfunction due to diabetes impacts gait and balance and that neural mobilization techniques may enhance nerve function and overall mobility. Statistical analysis using Pearson’s correlation will determine the strength of relationships between sensory impairment and the measured physical performance outcomes. This research could provide a basis for preventive and rehabilitative strategies in diabetic individuals, emphasizing early detection and targeted physiotherapy interventions to maintain functional independence and reduce fall risk. Ethical clearance, informed consent, and non-invasive procedures ensure the study’s scientific and ethical integrity. By linking peripheral sensory dysfunction with neural dynamics and movement outcomes, this research hopes to contribute meaningfully to the management of diabetic complications.


 
Close