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CTRI Number  CTRI/2025/07/090738 [Registered on: 11/07/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Special Exercise Program to Help Manage Symptoms of Diabetic Nerve disorder 
Scientific Title of Study   Effectiveness of Functional Neural Stretching and Weight-Bearing Exercise for the management of Diabetic 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  Mehedi Hasan Badsha 
Designation  Undergraduate student 
Affiliation  Jashore University of Science and Technology 
Address  Room: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801323149681  
Fax    
Email  mehedihasanbadsha36@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Md Feroz Kabir 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room: 409, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801765932545  
Fax    
Email  feroz@just.edu.bd  
 
Details of Contact Person
Public Query  
Name  Dr Md Feroz Kabir 
Designation  Assistant Professor 
Affiliation  Jashore University of Science and Technology 
Address  Room: 409, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology



7408
Other 
Phone  8801765932545  
Fax    
Email  feroz@just.edu.bd  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology 
 
Primary Sponsor  
Name  Department of Physiotherapy and Rehabilitation 
Address  Jashore University of Science and Technology, Jashore-7408, Bangladesh 
Type of Sponsor  Other [University] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Feroz Kabir  BIRDEM General Hospital  Room - 312, Department of Physiotherapy, BIRDEM General Hospital, Shahbag, Dhaka - 1000, Bangladesh

 		 8801765932545

feroz@just.edu.bd 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E116||Type 2 diabetes mellitus with other specified complications,  
 
Intervention / Comparator Agent
Modification(s)  
Type  Name  Details 
Intervention  Functional Neural Stretching and Weight-Bearing Exercise  Functional Neural Stretching: 1. Sciatic Nerve Mobilization uses neurodynamic stretches. 2. Tibial Nerve Glide techniques. 3. Sural Nerve Mobility. 4. Peroneal Nerve Stretch. Weight Bearing Exercise: 1. Sit-to-Stand Exercise. 2. Step-Ups and Mini Squats. 3. Heel-to-Toe Walking. 
Comparator Agent  Standard physiotherapy  Conventional physiotherapy: 1. Conventional Modalities: Transcutaneous Electrical Nerve Stimulation (TENS) 2. Resistance Training: Using therabands 3. Ankle Pumping 4. Education: Diabetic foot care, posture correction and lifestyle modifications.  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Diagnosed with diabetic peripheral neuropathy for a minimum duration of 1 year; HbA1c level is 9% or higher; Interested in and physically able to take part in physiotherapy sessions; Voluntarily agrees to join the study by signing informed consent 
 
ExclusionCriteria 
Details  Severe foot ulcers or amputation; Cardiopulmonary contraindications to exercise; Cognitive impairment; Any type of traumatic fracture
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
1. Pain by Visual Analog Scale (VAS)
2. Neuropathy Symptoms by Michigan Neuropathy Screening Instrument (MNSI)

 		 8 weeks
 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. Goniometer for Ankle Range of Motion.
2. Timed Up & Go test (TUG) for mobility measure.
3. Manual Muscle Testing (MMT) for Muscle Strength.
4.WHOQOL for Quality of Life. 		 8 weeks 
 
Target Sample Size
Modification(s)  		 Total Sample Size="84"
Sample Size from India="0" 
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)   Date Missing 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  25/07/2025 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Applicable 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (feroz@just.edu.bd).

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 This randomized controlled trial evaluates the effectiveness of combining Functional Neural Stretching and Weight-Bearing Exercises for managing diabetic neuropathy in individuals with type 2 diabetes. Conducted at BIRDEM General Hospital, Dhaka, with 86 participants aged 40-80, the study compares this intervention to standard physiotherapy over 8 weeks, assessing pain, neuropathy symptoms, ankle range of motion, mobility, muscle strength and quality of life. By enhancing nerve mobility, circulation and lower limb strength, the intervention aims to reduce neuropathic pain and improve function. This trial addresses gaps in non-invasive, accessible treatments, particularly in resource-limited settings and may inform cost-effective rehabilitation protocols and policy changes for better diabetic neuropathy management. Results will guide clinical practice and future research on exercise dosage and long-term effects. 
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