| CTRI Number |
CTRI/2025/05/086376 [Registered on: 06/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the Impact of Smart movement on Brain Function and Speed of response in People with Type-2 Diabetes |
|
Scientific Title of Study
|
Effect of Dual-Task Training on Cognitive Functions and Reaction Time in Individuals with Type-2 Diabetes Mellitus: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Krupal Jenish Modi |
| Designation |
Assistant Professor |
| Affiliation |
Vibrant Physiotherapy College |
| Address |
Ground Floor, Physiotherapy Department, Vibrant Physiotherapy College, Vibrant Campus, Vibrant Way, Masma, Surat Olpad road, Surat
Ground Floor, Physiotherapy Department, Vibrant Physiotherapy College, Vibrant Campus, Vibrant Way, Masma, Surat Olpad road, Surat
Surat
GUJARAT
394540
India |
| Phone |
9726661168 |
| Fax |
|
| Email |
krupalmodi.km@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Krupal Jenish Modi |
| Designation |
Assistant Professor |
| Affiliation |
Vibrant Physiotherapy College |
| Address |
Ground Floor, Physiotherapy Department, Vibrant Physiotherapy College, Vibrant Campus, Vibrant Way, Masma, Surat Olpad Road, Surat.
Ground Floor, Physiotherapy Department, Vibrant Physiotherapy College, Vibrant Campus, Vibrant Way, Masma , Surat Olpad Road, Surat 394540.
Surat
GUJARAT
394540
India |
| Phone |
9726661168 |
| Fax |
|
| Email |
krupalmodi.km@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krupal Jenish Modi |
| Designation |
Assistant Professor |
| Affiliation |
Vibrant Physiotherapy College |
| Address |
Ground Floor, Physiotherapy Department, Vibrant Physiotherapy College, Vibrant Campus, Vibrant Way, Masma, Surat Olpad Road, Surat.
Ground Floor, Physiotherapy Department, Vibrant Physiotherapy College, Vibrant Campus, Vibrant Way, Masma, Surat Olpad Road, Surat 394540.
Surat
GUJARAT
394540
India |
| Phone |
9726661168 |
| Fax |
|
| Email |
krupalmodi.km@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Krupal Jenish Modi |
| Address |
House Number 7/4878, First Floor, Dangisheri 1, Delhigate, Surat 395003, Gujarat, India. |
| Type of Sponsor |
Other [SELF] |
|
|
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 Krupal Modi |
Vibrant Physiotherapy College |
OPD, Vibrant Physiotherapy College, Vibrant Campus, Surat Olpad Road, Masma, Surat, Gujarat 394540
Surat
GUJARAT |
9726661168
krupalmodi.km@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethical Committee, SPB Physiotherapy College, Surat. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
Dual Task Training (DTT)
|
DTT typically includes a primary motor task and a secondary cognitive or motor task, practiced together. It aims to improve divided attention and functional ability by combining physical and cognitive tasks. Participants here are asked to perform total 9 structured Motor-cognitive dual task training exercises, each exercise lasting for 4 minutes with 2 min resting time after each 2 exercises (Total 45 minutes). |
| Comparator Agent |
Supervised Walking |
participants are asked to walk on a path of 15 meter with a speed which is considered to be around 100 steps per minute on a levelled surface wearing comfortable clothing for 45 minutes (Rest in between when needed); 3 times/week for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Duration of DM type 2: Between 5 years to 10 years
Low risk of fall according to Timed Up and Go test (TUG)
Having Mild Cognitive Impairment: Score between 18-23 according to Mini
Mental Status Examination (MMSE)
Volunteer for take part in study/ consent
Having basic understanding of command
Literacy: Able to understand and write in one of the three languages:
English/Gujarati/Hindi |
|
| ExclusionCriteria |
| Details |
Type 1 diabetes
Neurological disorders (e.g., stroke, Parkinson’s, Alzheimer’s)
Diabetic neuropathy
Orthopedic or rheumatologic conditions limiting exercise
Major musculoskeletal deformities (e.g., amputation, scoliosis)
Serious comorbidities (e.g., PAD, drug use, heart failure, pulmonary disease, arrhythmia)
History of dizziness, visual, or vestibular issues |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognitive Function using Montreal Cognitive Assessment
|
Baseline (before intervention)
Week 4(after intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reaction Time using RT Apparatus |
Baseline (before intervention)
Week 4(after intervention) |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
19/05/2025 |
| 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="2"
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
|
Primary Purpose of the Protocol:
To evaluate the effect of dual-task training on cognitive functions and reaction time in individuals with Type-2 Diabetes Mellitus. The study aims to determine whether integrating simultaneous cognitive and motor tasks can lead to measurable improvements in these parameters compared to standard care.Study Hypothesis:
It is hypothesized that individuals with Type-2 Diabetes Mellitus undergoing dual-task training will demonstrate significantly greater improvements in cognitive functions and reaction time compared to those receiving standard care or single-task interventions. |