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CTRI Number  CTRI/2024/10/075765 [Registered on: 23/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Impact of Square Stepping Exercise on balance and risk of fall in individuals with Diabetic Neuropathy. 
Scientific Title of Study   Effect of Square Stepping Exercise on balance and risk of fall in subjects with 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  Trishna Deka 
Designation  PG Student 
Affiliation  Padmashree Institute of Physiotherapy 
Address  MPT Student (MPT in Neurological Sciences), Padmashree Institute of Physiotherapy.
149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri
Bangalore
KARNATAKA
560060
India 
Phone  9864741511  
Fax    
Email  trishnadeka21july@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sudheera Kunduru 
Designation  Professor 
Affiliation  Padmashree Institute of Physiotherapy 
Address  HoD, Department of Physiotherapy, Padmashree Institute of Physiotherapy
149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri,
Bangalore
KARNATAKA
560060
India 
Phone  9845061340  
Fax    
Email  sudheera.physio@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sudheera Kunduru 
Designation  Professor 
Affiliation  Padmashree Institute of Physiotherapy 
Address  HoD, Department of Physiotherapy, Padmashree Institute of Physiotherapy.
149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri,
Bangalore
KARNATAKA
560060
India 
Phone  9845061340  
Fax    
Email  sudheera.physio@gmail.com  
 
Source of Monetary or Material Support  
Padmashree Institute of Physiotherapy, 149, Padmashree Campus, Kommaghatta, Kengeri, Bangalore, Karnataka, India, 560060 
 
Primary Sponsor  
Name  Trishna Deka 
Address  Padmashree Institute of Physiotherapy, 149, Padmashree Campus, Kommaghatta Village, Sulikere (Post.), Kengeri, Bangalore, Karnataka 560060 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sudheera Kunduru  ESIC Hospital  Rajajinagar, Bangalore
Bangalore
KARNATAKA 
9845061340

sudheera.physio@gmail.com 
Sudheera Kunduru  Padmashree Diagnostics  Vijaynagar, Bangalore
Bangalore
KARNATAKA 
9845061340

sudheera.physio@gmail.com 
Sudheera Kunduru  Padmashree Physiotherapy Clinic and Rehab Centre  Nagarbhavi, Bangalore
Bangalore
KARNATAKA 
9845061340

sudheera.physio@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Padmashree Institutional Ethics Committee, Padmashree Campus Kengeri  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  Conventional Therapy  Participants will be asked to perform active range of motion (AROM) exercise for both the lower limbs (including hip, knee and ankle joints), gait training and spot marching on a stable surface. Intervention will be given for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks.  
Intervention  Square Stepping Exercise  The exercises will be performed by the subjects on a thin mat. The mat will be divided into 40 small squares, each measuring 25 cm square, with total area of 250 cm into 100 cm. There are 200 movement patterns in the SSE, divided into three levels of difficulty: beginner, intermediate, and advanced. The intermediate and advanced levels each have three levels, while the beginners level has two levels in turn. It will begin with walking-like movement patterns and progress to increasingly complex patterns that require for lateral, diagonal, and backward movements in addition to forward movement. It will be advised to the participants to avoid stepping on the dividing lines of the squares. Intervention will be given for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks.  
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Type 2 Diabetes Mellitus subjects (duration more than 5 years).
2. Michigan Neuropathy Screening Instrument, Physical Assessment Score more than 2 out of 10.
3. Subjects with Fear of Fall (FES-I Score more than 20).
4. Ability to walk independently without an assistive device. 
 
ExclusionCriteria 
Details  1. Subjects having diabetic foot ulcers, partial or total foot amputation.
2. Subjects with any other neurological or musculoskeletal impairments.
3. Subjects with major vascular complications (venous/arterial ulcers).
4. Subjects with severe retinopathy or severe nephropathy.
5. Subjects with severe psychiatric illness.
6. Subjects with severe hearing and visual deficits.
7. Non-cooperative subjects.
8. Existence of any other factors that interfere with balance except Diabetic Neuropathy. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Berg Balance Scale   Maximum Score 56 
 
Secondary Outcome  
Outcome  TimePoints 
Timed Up and Go (TUG) Test  Normal is 10 seconds or less 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/05/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 Neuropathy (DN) is one of the commonest causes of peripheral neuropathy and is defined as signs and symptoms of peripheral nerve dysfunction in a patient with diabetes mellitus in whom other causes of peripheral nerve dysfunction have been excluded. When compared to people with T1DM, the incidence is greater in T2DM. Individuals with diabetes are susceptible to developing neuropathy at any point, with an increased risk correlating with advancing age and a duration of diabetes exceeding five years. Diabetic neuropathy is a major cause of falls in elderly patients and people with peripheral neuropathy caused by diabetes often experience balance disorders. Patients with this condition experience more postural sway, particularly when their eyes are closed. Exercise has been shown to enhance various metabolic factors that can influence nerve health and micro-vascular function, potentially providing indirect protection against peripheral nerve damage. Patients with diabetic neuropathy benefit from exercise therapy, including balance exercises, since it increases oxygen pressure in the skin, lower limbs, and chest, hence improving skin blood flow. Alterations in shear stress and pressure on the plantar surfaces during standing tasks can activate mechanoreceptors, transmitting signals to higher nervous centres and thereby, enhancing balance in patients with diabetic neuropathy. Research suggests that Square Stepping Exercise is an apparently most effective alternative to walking for improvement of balance. Its effectiveness has been shown to be beneficial for subjects with stroke, Parkinson’s Disease, Multiple Sclerosis and elderly population. But there is a dearth of literature concerning Diabetic Neuropathy. Hence, the present study is developed with the aim to investigate the effect of SSE on balance and risk of falls in subjects with Diabetic Neuropathy. This study will include 62 participants, who will be divided equally into two groups: Group A & Group B. Participants in Group A will receive Square Stepping Exercise and Group B will receive Conventional Therapy. Both groups will receive intervention for 50 minutes with 10 minutes of warm-up and cool-down period, 3 times a week for 8 weeks. Data will be collected from both the groups pre and post intervention by using Berg Balance Scale and Timed Up and Go test. Statistical analysis will be done by Statistician to compare the results. 
 
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