| CTRI Number |
CTRI/2025/09/094801 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of balance in People with Type 2 diabetes while doing single activity and while doing two activities together on fitness and blood sugar control |
|
Scientific Title of Study
|
Association of single and dual task balance performance on physical fitness and glycemic control levels among type 2 diabetes mellitus 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 |
Ayesha Siddiqa |
| Designation |
Master of physiotherapy |
| Affiliation |
Sri Devaraj Urs Academy of Higher Education and Research Institute |
| Address |
R.L.Jalappa College of Physiotherapy,Department of Physiotherapy, Sri Devaraj Urs Academy of Higher Education and Research Institute Tamaka kolar karanataka 563103
Kolar
KARNATAKA
563103
India |
| Phone |
7892251828 |
| Fax |
|
| Email |
fathimashahur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSarulatha H |
| Designation |
professor and Guide |
| Affiliation |
RL Jalappa hospital and research institute , |
| Address |
RL Jalappa hospital and research institute ,Sri Devaraj Urs Academy of Higher Education and Research Tamaka kolar karnataka 563103
Kolar
KARNATAKA
563103
India |
| Phone |
9686235790 |
| Fax |
|
| Email |
sarulathah@sduaher.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSarulatha H |
| Designation |
professor and Guide |
| Affiliation |
RL Jalappa hospital and research institute , |
| Address |
RL Jalappa hospital and research institute ,Sri Devaraj Urs Academy of Higher Education and Research Tamaka kolar karnataka 563103
Kolar
KARNATAKA
563103
India |
| Phone |
9686235790 |
| Fax |
|
| Email |
sarulathah@sduaher.ac.in |
|
|
Source of Monetary or Material Support
|
| R.L.Jalappa College of Physiotherapy
Sri Devaraj Urs Academy of Higher Education and Research Institute Tamaka kolar karanataka India 563103
|
|
|
Primary Sponsor
|
| Name |
Sri Devaraj Urs Academy of Higher Education and Research Institute |
| Address |
R.L.Jalappa College of Physiotherapy
Sri Devaraj Urs Academy of Higher Education and Research Institute Tamaka kolar karanataka India 563103
|
| Type of Sponsor |
Other [Deemed to be University] |
|
|
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 |
| Dr Ayesha Siddiqa PT |
R.L.Jalappa Hospital and research centre |
ROOM NO 3 Department of Physiotherapy,Neuro rehab division, Sri Devaraj Urs Academy of Higher Education and Research Institute Tamaka kolar karanataka 563103
Kolar
KARNATAKA |
7892251828
fathimashahur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| central ethics committe,Sri Devaraj Urs Academy of Higher Education and Research Institute Tamaka kolar karanataka 563103 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Type 2 Diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
People diagnosed as Type 2 Diabetes Mellitus
Cognitive ability - score of more than 88 by 100 on Addenbrooke’s cognitive examination scale.
|
|
| ExclusionCriteria |
| Details |
Diagnosed with dementia or Memory disorder
History of neurological disorder like (stroke, Parkinson’s disease)
Severe Visual Impairment
People with speech disorder
People with presence of diabetic Neuropathy
Inability to stand Unaided for at least 1 min
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
dual task balance parameters
sway velocity
max medio lateral deviation
max anterior deviation
max posterior deviation
|
single point
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
29/09/2025 |
| 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="1"
Months="0"
Days="0" |
|
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
|
Summary:
This observational study investigates the association between balance performance under single and dual-task conditions, physical fitness, and glycemic control that is HbA1c levels in patients with Type 2 Diabetes Mellitus. A total of 240 participants aged 30 to 60 will be grouped based on HbA1c levels into controlled, poorly controlled, and uncontrolled categories. Balance will be assessed using plantar pressure equipment, and physical fitness will be measured via hand grip strength. Cognitive function will be screened using the Addenbrookes Cognitive Examination, and neuropathy will be ruled out using a biothesiometer. Dual-task balance tests will include both basic and complex cognitive tasks. The study aims to identify how glycemic control and physical fitness influence balance performance, which can help predict fall risk and guide tailored interventions. Data analysis will involve ANOVA or Kruskal-Wallis tests and correlation analyses. |