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CTRI Number  CTRI/2025/03/082188 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 08/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of Lower limb Strength in Balance Recovery for People with Diabetes 
Scientific Title of Study   IMPACT OF LOWER LIMB MUSCLE STRENGTH ON FORWARD REACTIVE STEPPING IN DIABETIC PATIENTS 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Charulatha K 
Designation  Student 
Affiliation  SRIHER 
Address  Faculty of Physiotherapy block, Room 2.2, Sri Ramachandra Institute of Higher Education and research,No 1 Ramachandra nagar, Porur

Chennai
TAMIL NADU
600116
India 
Phone    
Fax    
Email  charukamaraj00@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  CR PRAVEEN KUMAR 
Designation  Assistant professor 
Affiliation  Sri Ramachandra Institute of Higher Education and research 
Address  Faculty of Physiotherapy, Room 2.3, Sri Ramachandra Institute of Higher Education and research,No 1 Ramachandra nagar, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9445334017  
Fax    
Email  praveenkumar.cr@sriramachandra.edu.in  
 
Details of Contact Person
Public Query
 
Name  CR PRAVEEN KUMAR 
Designation  Assistant professor 
Affiliation  Sri Ramachandra Institute of Higher Education and research 
Address  Faculty of Physiotherapy, Room 2.3, Sri Ramachandra Institute of Higher Education and research,No 1 Ramachandra nagar, Porur

Chennai
TAMIL NADU
600116
India 
Phone  9445334017  
Fax    
Email  praveenkumar.cr@sriramachandra.edu.in  
 
Source of Monetary or Material Support  
Sri Ramachandra Institute of Higher Education and Research  
 
Primary Sponsor  
Name  Sri Ramachandra Institute of Higher Education and Research  
Address  No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu, 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 
Charulatha K  SRIHER- Faculty of Physiotherapy OPD   Faculty of Physiotherapy block - room no 2.2, 2nd floor -Sri Ramachandra Institute of Higher Education and Research, Porur , Chennai- 600116 Chennai TAMIL NADU
Chennai
TAMIL NADU 
7305337656

charukamaraj00@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee - Student projects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diabetic patients of both genders, aged 45 to 60 years
Diagnosed with Type 1 and 2 diabetes mellitus for at least 3 to 5 years
Able to walk independently without assistive devices.
No history of major foot complications, such as amputations or severe ulcers. 
 
ExclusionCriteria 
Details  Neurological conditions (e.g., stroke, Parkinson’s disease) that independently affect
balance.
Diabetic Neuropathy
Use of medications that severely affect muscle strength or coordination.
Any orthopedic condition that limits mobility (e.g., recent lower limb surgery or
severe arthritis). 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
First step length- the distance covered with the first step after initiating movement, indicating how far the body progresses with the first stride.

First step time - the duration taken to complete the first step, indicating the speed at which the first step is performed.
Balance recovery distance is the distance the body moves or shifts to regain stability after losing balance.

Muscle strength in kilograms in a dynamometer for plantar flexors (PF), hip abductors, and knee extensors refers to the maximum force exerted by these muscle groups, measured in kilograms using a handheld device (dynamometer). 
At the time of evaluation 
 
Secondary Outcome  
Outcome  TimePoints 
Screening for Diabetic Neuropathy  At the time of evaluation 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   24/03/2025 
Date of Study Completion (India) 01/04/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
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  
Diabetes mellitus (DM) impairs blood glucose regulation, affecting multiple body systems and
often leading to muscle weakness, balance issues, and increased fall risk. Balance in individuals with diabetes is impacted by factors such as muscle weakness, plantar insensitivity, and proprioception deficits, which all contribute to diminished stability and compensatory abilities. While common balance assessments like the Berg Balance Scale and Timed Up and Go Test focus primarily on anticipatory postural control, they lack in assessing reactive balance—a critical component for fall prevention. The Balance Evaluation Systems Test (BESTest), however, measures reactive compensatory stepping, which is especially relevant for diabetes-related balance deficits.This observational study aims to explore how lower extremity muscle strength affects forward reactive stepping ability in diabetic patients, a vital skill for maintaining stability in unexpected balance disruptions. Using the BESTest’s lean-and-release method, the study will measure reactive balance responses, while muscle strength will be assessed with a handheld dynamometer, focusing on hip abductors, knee extensors, and ankle plantarflexors. The relationship between muscle strength and forward stepping metrics, including step time, step distance, and recovery time, will be analysed.Participants will include Type 1 and 2 diabetic patients aged 30 to 60 years, with a diabetes duration of 3-5 years, no severe foot complications, and independent mobility. Findings from this study aim to fill a gap in understanding the role of
muscle strength in reactive balance control, providing valuable insights for improving balance assessment and fall prevention strategies for diabetic individuals.
 
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