| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
|
|
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. |