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CTRI Number  CTRI/2025/12/099816 [Registered on: 24/12/2025] Trial Registered Prospectively
Last Modified On: 17/09/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Developing and Testing a Somatosensory Training Program for People with Diabetic Peripheral Neuropathy 
Scientific Title of Study   Development, Validation and Feasibility Testing of a Hip and Ankle Strategy based Somatosensory Training Protocol in Individuals 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  Jatin Sangwan 
Designation  PhD Scholar 
Affiliation  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

Ambala
HARYANA
133207
India 
Phone  9991266305  
Fax    
Email  jatinphdscholar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akanksha Saxena 
Designation  Associate Professor 
Affiliation  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

Ambala
HARYANA
133207
India 
Phone  7906989678  
Fax    
Email  akankshasaxena623@mmumullana.org  
 
Details of Contact Person
Public Query
 
Name  Dr Akanksha Saxena 
Designation  Associate Professor 
Affiliation  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

Ambala
HARYANA
133207
India 
Phone  7906989678  
Fax    
Email  akankshasaxena623@mmumullana.org  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Maharishi Markandeshwar (Deemed to be University) 
Address  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation,Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana, India 
Type of Sponsor  Research institution and hospital 
 
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 Akanksha Saxena  Physiotherapy OPD  Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU), Mullana, Ambala
Ambala
HARYANA 
9991266305

jatinphdscholar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Maharishi Markandeshwar Institute of Medical Sciences & Research, Mullana, Ambala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G64||Other disorders of peripheral nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ankle and Hip strategy based Somatosensory Training Protocol  Training protocol having 14 exercises; 5 for ankle strategy training, 5 for hip strategy training, and 4 exercises focused on both hip and ankle strategy. Each exercise initially perform on the ground, and then on bosu ball for adding somatosensory training component. These exercises will help in improving balance and gait parameters in individuals having diabetic peripheral neuropathy. 
Comparator Agent  Diabetic Foot care education and conventional lower extremity exercises  Diabetic foot care education will be given on 1st day of intervention and conventional lower extremity range of exercises will be given to comparator group. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Pre-diagnosed cases of DPN or Type II diabetes mellitus for 5 years
BMI 18.5 to 29.9 kg per m2
Scored more than 2 out of 13 on Michigan Neuropathy Screening Instrument questionnaire
HbA1C report more then or equal to 6 percent and not older than 3 months
Willing to participate in study 
 
ExclusionCriteria 
Details  Severe Musculoskeletal impairment of lower limb
Any other diagnosed neurological impairment
Severe Retinopathy
Severe Nephropathy
Foot Ulcers
Major Vascular Complication
Unable to walk independently with or without an assistive device 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Vibration perception   Baseline, 2 week, 4 week, 6 week 
 
Secondary Outcome  
Outcome  TimePoints 
Proprioception  Baseline, 2 week, 4 week, 6 week 
Light touch pressure threshold   Baseline, 2 week, 4 week, 6 week 
Balance  Baseline, 2 week, 4 week, 6 week 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/01/2026 
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="8"
Days="30" 
Recruitment Status of Trial (Global)
Modification(s)  
Open to Recruitment 
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  

The study will be conducted in tertiary care Superspeciality hospital in 3 phases; development of protocol, its content validation and feasibility testing. In first phase, based on the literature showing positive effects in improving somatosensory functions and balance, a structured exercise protocol will be developed which incorporates closed chain hip and ankle exercises and somatosensory exercises.  In second phases, content validity of exercise protocol was measured and items will be eliminated or revised if score is less after expert’s evaluations. Total 30 participants will be recruited in third phase i.e. feasibility trial by Criterion-Based Purposive sampling method. After signing the consent form, participants will be assessed at baseline, after 2 week, 4 week and 6 week by selected outcome measures. Experimental group receives newly developed hip and ankle strategy-based somatosensory training protocol and conventional group receives hip strengthening exercises, ankle strengthening exercises, and weight bearing activities on unstable surface. Normality will be assessed by Shapiro-wilk test. If p-value is less than 0.05, indicates data is not normally distributed and p-value more than 0.05 indicates data is normally distributed. If the data is distributed normally, parametric tests will be used for within group analysis, between group analysis, and repeated measure analysis. If the data is not normally distributed, non-parametric test will be used. P-value less than 0.05 indicate significant results and more than 0.05 indicate statistical significant results.

 
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