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CTRI Number  CTRI/2026/03/105671 [Registered on: 09/03/2026] Trial Registered Prospectively
Last Modified On: 28/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Single Arm Study 
Public Title of Study   Development, Validation and Testing of Foot Sense Therapeutic Device in Patients with Diabetic Peripheral Neuropathy 
Scientific Title of Study   Development, Validation and Feasibility Testing of a Proprioception and Vibration Sense Therapeutic Device in Patients with 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  Lakshay Panchal 
Designation  PhD Scholar 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Room No. B 33-4, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8295995706  
Fax    
Email  lbpanch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Manu Goyal 
Designation  Principal 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Room No. B 31-07, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8307715320  
Fax    
Email  manugoyal1111@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Manu Goyal 
Designation  Principal 
Affiliation  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Room No. B 31-07, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana

Ambala
HARYANA
133207
India 
Phone  8307715320  
Fax    
Email  manugoyal1111@gmail.com  
 
Source of Monetary or Material Support  
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar, Mullana, Dist Ambala, Haryana-India Pin 133207 
 
Primary Sponsor  
Name  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana-India 133207 
Type of Sponsor  Private medical college 
 
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 Subhasish Chatterjee  Maharishi Markandeshwar Super Specialty Hospital  Room No: S-111, First Floor, Maharishi Markandeshwar Super Specialty Hospital, Maharishi Markandeshwar (Deemed to be University), Mullana-Ambala, Haryana-India 133207
Ambala
HARYANA 		 8708660994

spc.mmipr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  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  NA  NA 
Intervention  Plantar Vibration and Proprioception training  An intervention program includes 6 weeks (5 times per week), including gamified proprioceptive training and local plantar vibration. The outcome evaluation will be done at baseline and post- intervention 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Type 2 diabetes mellitus induced diabetic peripheral neuropathy of lower limbs. Diabetes Duration minimum 5 years. HbA1C levels more than or equal to 6% and not older than 3 months. BMI and lt 30kg/m2. 
 
ExclusionCriteria 
Details  Vestibular system dysfunction in the last year. Diabetic foot ulcer. Acute cardiovascular diseases. History of any recent lower limb injury or recent surgery. Patient with impaired vision. Patients with significant psychiatric disorders. Patient with Autonomic dysfunctions 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Ankle Proprioception, Vibration Perception Threshold  The vibration perception scores with biothesiometer values and proprioception scores using the Pedalo-Sensamove Balance Test Pro and newly developed device will be taken at pre-intervention (Week zero) and post-intervention (Week 6) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   31/03/2026 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Diabetes is a common non-communicable disease which became a global health crisis, with the prevalence projected to reach 629 million by 2045. This surge, is particularly in lower-middle-income countries like India. This study aims to address the critical gap in DPN management by developing, validating, and assessing the feasibility of a novel, portable, and user-friendly therapeutic device. This device will facilitate early and cost-effective diagnosis of proprioceptive and vibration sense deficits and provide targeted training to improve these modalities in DPN patients. The study will be conducted in three phases: 1) Development Phase: Focuses on creating a device that incorporates vibration perception threshold evaluation and a proprioception training mechanism. 2) Validation Phase: Will determine the construct and concurrent validity of the developed device for evaluating proprioception and vibration perception threshold. 3) Pilot Trial: A pilot study will be conducted to assess the effects of vibration sense and proprioceptive training among DPN patients using the developed device. In Phase II, concurrent validity will be assessed by correlating device-derived proprioception and vibration perception scores with biothesiometer values and proprioception scores using the Pedalo-Sensamove Balance Test Pro, employing Pearson’s or Spearman’s correlation, and interpreting the results based on standard thresholds. Phase III will evaluate pre- and post-intervention changes using a parametric or a nonparametric test. 
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