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CTRI Number  CTRI/2025/12/099061 [Registered on: 15/12/2025] Trial Registered Prospectively
Last Modified On: 13/12/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effects of Nordic Walking and Backward Walking on Balance, Leg Coordination, and Walking Ability in People with Diabetic Nerve Problems 
Scientific Title of Study   Comparing Nordic Walking and Backward Walking on Balance, Lower limb Coordination and Gait parameters in Individuals with Diabetic Neuropathy : A Randomized Clinical Trial  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neha Mulla 
Designation  Assistant professor 
Affiliation  KAHER Institute of physiotherapy 
Address  Advanced physiotherapy centre ,Room no. 39, Department of Neurological Physiotherapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre

Belgaum
KARNATAKA
590010
India 
Phone  8660491303  
Fax    
Email  nehamulla@klekipt.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Neha Mulla 
Designation  Assistant professor 
Affiliation  KAHER Institute of physiotherapy 
Address  Advanced physiotherapy centre ,Room no. 39, Department of Neurological Physiotherapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre


KARNATAKA
590010
India 
Phone  8660491303  
Fax    
Email  nehamulla@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Parnika Gadgil 
Designation  Intern  
Affiliation  KAHER Institute of physiotherapy 
Address  Advanced physiotherapy centre ,Room no. 39, Department of Neurological physiotherapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre

Belgaum
KARNATAKA
590010
India 
Phone  9822652057  
Fax    
Email  parnikagadgil07@gmail.com  
 
Source of Monetary or Material Support  
KAHER Institute of Physiotherapy, Nehru Nagar , Belgavi 590010 
 
Primary Sponsor  
Name  KAHER institute of Physiotherapy 
Address  Advanced physiotherapy centre ,Room no. 39, Department of Neurological physiotherapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre  
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 
Parnika Gadgil  KAHER Institute of physioyhtherapy  Advanced physiotherapy centre ,Room no. 39, Department of Neurological physiotherapy ,Sagar floor , KLE Dr. Prabhakar Kore hospital and Medical Research centre
Belgaum
KARNATAKA 		 9822652057

parnikagadgil07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and 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  Backward walking   Backward walking for 45 mins, 4 times a week for 4 weeks  
Intervention  Nordic walking   Nordic walking for 45 minutes, 4 times a week for 4 weeks  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Participants of all gender aged between 40–70 years diagnosed with diabetes, and clinically confirmed with diabetic neuropathy, who are willing to participate for the study.
2. S-LANSS test with a minimum score of 12.
 
 
ExclusionCriteria 
Details  1. Severe musculoskeletal, cardiovascular, or vestibular disorders affecting gait or balance.
2. Active foot ulcers or infections.
3. Previous participation in structured balance or walking programs within last 3 months.
4. Patients with sensory loss on the feet.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Timed up and go test
LEMOCOT
10 meter walk test 		 4 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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 
Date of First Enrollment (India)   24/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  24/12/2025 
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 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  

This randomized clinical trial titled “Comparing Nordic Walking and Backward Walking on Balance, Lower Limb Coordination, and Gait Parameters in Individuals with Diabetic Neuropathy” aims to compare the effectiveness of two walking-based interventions in improving functional mobility among adults aged 40–70 years with diabetic neuropathy.A total of 24 participants will be randomly assigned to either a Nordic walking or backward walking group for a 4-week intervention. Pre- and post-assessments will be conducted using the Timed Up and Go Test, Lower Extremity Motor Coordination Test (LEMOCOT), and 10-Metre Walk Test to evaluate balance, coordination, and gait.The study seeks to determine which walking modality offers greater improvement in functional outcomes, thereby supporting evidence-based physiotherapy strategies for managing diabetic neuropathy.

 
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