| CTRI Number |
CTRI/2026/03/105820 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Balance and Body Awareness in Individuals with Diabetes |
|
Scientific Title of Study
|
Analysis impact of proprioception and reactive balance in diabetic individuals |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
saghar tabandeh |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Faculty of physiotherapy |
| Address |
Room No: 2.3 second floor, Sri Ramachandra faculty of physiotherapy, sri ramachandra Institute of higher education and research
Chennai TAMIL NADU 600116 India |
| Phone |
8431847818 |
| Fax |
|
| Email |
Saqar.tabandeh@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
saghar tabandeh |
| Designation |
Post Graduate |
| Affiliation |
Sri Ramachandra Faculty of physiotherapy |
| Address |
Room No: 2.3 second floor, Sri Ramachandra faculty of physiotherapy, sri ramachandra Institute of higher education and research
Chennai TAMIL NADU 600116 India |
| Phone |
8431847818 |
| Fax |
|
| Email |
Saqar.tabandeh@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Praveen Kumar CR |
| Designation |
Assisstant Professor |
| Affiliation |
sri ramachandra faculty of physiotherapy |
| Address |
Room No:2.3 second floor, Sri Ramachandra faculty of physiotherapy, Sri Ramachandra institute of higher education and research ,porur
Chennai TAMIL NADU 600116 India |
| Phone |
9445334017 |
| Fax |
|
| Email |
praveenkumar.cr@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra institute of higher education and research DU |
| Address |
No . 1 ,Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research ,Ramachandra Nagar , Porur , Chennai, Tamil Nadu 600116 |
| 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 |
| saghar tabandeh |
Sri Ramachandra Institute of Higher Education and Research |
No 1 , New Block OPD, Ground floor, Sri Ramachandra Faculty Of Physiotherapy , SRIHER , porur , 600116 Chennai TAMIL NADU |
8431847818
Saqar.tabandeh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR SUDENTS PROJECTS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
diabetic and non-diabetic |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
diabetic group :
diagnosed with type 2 diabetes mellitus
able to ambulate independently without assistive devices
Non-Diabetic Group
No history of diabetes mellitus
Age- and sex-matched with diabetic group
No history of balance or neurological disorders
Willing to participate and provide informed consent
willing to participate and provide informed consent
controlled DM |
|
| ExclusionCriteria |
| Details |
Neurological conditions (e.g., stroke, Parkinson’s disease) that independently affect balance.
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 |
| Functional Lower limb Proprioceptive Error |
Baseline (single assessment during study visit) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reactive Balance Parameters ( Forward Stepping - BESTest ) |
Baseline (single session during assessment) |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
25/03/2026 |
| 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="3" Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Diabetes Mellitus is commonly associated with peripheral neuropathy and sensory impairments that can affect proprioception and postural control, thereby increasing the risk of balance dysfunction and falls . Proprioceptive deficits may impair the ability to accurately perceive joint position ,while delayed reactive balance responses can compromise the ability to recover stability following unexpected perturbations . Although several studies has evaluated static balance in individuals with diabetes , limited research has examined both proprioception and reactive balance in this population. This study is an observational , cross-sectional study with a total of 60 participants aged 40-65 years will be recruiting using convenience sampling, including 30 30 individuals with Type 2 diabetes mellitus and 30 age and sex matched non-diabetic individuals. Functional lower limb proprioception will be assessed using a target toe-touch error test, and reactive balance will be evaluated using the forward stepping component of BESTest. Outcome measures include proprioceptive error distance ,first step time , first step length , number of steps and balance recovery time . The findings in this study may help identify impairments in proprioception and reactive balance among diabetic individuals and support the development of targeted physiotherapy interventions for fall prevention and balance rehabilitation. |