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CTRI Number  CTRI/2026/02/103578 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 06/02/2026
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   A Study to Compare Balance Exercises on Floor and Foam Surfaces in People with Nerve Problems Due to Diabetes 
Scientific Title of Study   Effectiveness of Balance Exercises Performed on Floor Versus Foam Platform Surfaces on Balance, Ankle Proprioception and Dynamic Gait Index 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  Riya Jain 
Designation  Postgraduate Student 
Affiliation  Manav Rachna International Institute of Research and Studies 
Address  QG-08, Q block, Out patient department, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Sector-43, Faridabad-121004, Haryana, India

Faridabad
HARYANA
121004
India 
Phone  8010340785  
Fax    
Email  riyajain0785@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunita Kumari 
Designation  Assistant Professor 
Affiliation  Manav Rachna International Institute of Research and Studies  
Address  QG-08, Q block, Out patient department, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Sector-43, Faridabad-121004, Haryana, India

Faridabad
HARYANA
121004
India 
Phone  8800125047  
Fax    
Email  Sunita.fas@mriu.edu.in  
 
Details of Contact Person
Public Query  
Name  Riya Jain 
Designation  Postgraduate Student 
Affiliation  Manav Rachna International Institute of Research and Studies  
Address  QG-08, Q block, Out patient department, Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies, Sector-43, Faridabad-121004, Haryana, India

Faridabad
HARYANA
121004
India 
Phone  8010340785  
Fax    
Email  riyajain0785@gmail.com  
 
Source of Monetary or Material Support  
Manav Rachna International Institute of Research and Studies, Department of Physiotherapy, School of Allied Health Sciences, Sector-43, Faridabad-121004, Haryana, India 
 
Primary Sponsor  
Name  Riya Jain 
Address  Manav Rachna International Institute of Research and Studies, Sector-43, Faridabad-121004, Haryana, India 
Type of Sponsor  Other [Self] 
 
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 Riya Jain  Manav Rachna International Institute of Research and Studies  QG-08, Q block, Out Patient Department, Department of Physiotherapy, School of Allied Health Sciences, MRIIRS, Faridabad
Faridabad
HARYANA 		 8010340785

riyajain0785@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Departmental Ethical Committee (DEC), Department of Physiotherapy, School of Allied Health Sciences, Manav Rachna International Institute of Research and Studies (MRIIRS)  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  Balance Exercises on Floor Surface  Balance exercises will be performed on stable floor surfaces under supervision of a physiotherapist. Exercises will include double leg standing, single leg standing, neck movements, free leg swinging, heel and toe raises, trunk rotation and walking in place. Training will be provided for 30 minutes per session, four sessions per week for four weeks.  
Intervention  Balance Exercises on Foam Surface  Balance exercises will be performed on foam platform surfaces under supervision of a physiotherapist. Exercises will include double leg standing, single leg standing, neck movements, free leg swinging, heel and toe raises, trunk rotation and walking in place. Training will be provided for 30 minutes per session, four sessions per week for four weeks. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients pre diagnosed with type 2 diabetes mellitus for atleast 5 years, both male and female, Aged 45-65 years old, score greater than 2 out of 13 on MNSI questionnaire and score equal to or more than 1 out of 10 on physical assessment, BBS score between 35-45, ability to walk independently with or without assistive device.
 
 
ExclusionCriteria 
Details  Presence of severe musculoskeletal disorders (for example- foot ulcers, fractures, joint replacement, degenerative joint disease)
Major vascular complication (for example- peripheral arterial disease, venous or arterial ulcers)
Inability to walk independently
History or evidence of neurological disorder (for example-stroke, Parkinson’s, paraplegia, hemiparesis, cerebellar ataxia etc)
History or evidence of cardiovascular disorders (for example- uncontrolled hypertension, ischemic heart disease, history of angina, shortness of breath)
Visual and vestibular impairment significantly affecting balance
Use of medications significantly impacting postural control
Enrolled in another balance training program
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Berg Balance Scale (BBS) used to assess balance.
2. Position reposition test used for assessing the ankle joint position sense.
3. Dynamic Gait Index (DGI) is used to assess dynamic balance and gait adaptability. 		 All primary outcome measures will be assessed at baseline (pre- intervention) and after 4 weeks of intervention (post-intervention) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   18/02/2026 
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="0"
Months="6"
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   Diabetic Peripheral Neuropathy leads to sensory impairment, reduced proprioception, and balance dysfunction. Balance training is commonly used in rehabilitation of individuals with diabetic peripheral neuropathy. however, the influence of different support surfaces during balance exercises is not well established.
This quasi-experimental study aims to evaluate and compare the effectiveness of balance exercises performed on floor surfaces versus foam platform surfaces on balance, ankle proprioception, and dynamic gait index in individuals with diabetic peripheral neuropathy. A total of 50 participants with DPN will be recruited using convenient sampling and allocated into two intervention groups. Group A will receive balance training on progressively challenging floor surfaces, while Group B will receive balance training on foam platforms of increasing density.
Both groups will undergo supervised balance training sessions for 4 weeks, with interventions administered four times per week. Training session duration is 30 minutes. Outcome measures including the Berg Balance Scale (BBS), Dynamic Gait Index (DGI), and ankle joint position sense (position reposition test), will be assessed at baseline and after 4 weeks of completion of the intervention.
The findings of this study are expected to identify the more effective surface for balance training, thereby contributing to optimized rehabilitation strategies aimed at improving balance, proprioception, gait performance in individuals with diabetic peripheral neuropathy.
 
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