| CTRI Number |
CTRI/2025/12/099621 [Registered on: 22/12/2025] Trial Registered Prospectively |
| Last Modified On: |
21/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out whether Special Exercise program improves Balance and Mental Function in older people with Type 2 Diabetes Mellitus. |
|
Scientific Title of Study
|
Effect of Sensorimotor Training on Balance and Cognitive Performance in Community Dwelling Elderly with Type II 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 |
Dr Sharanya Bapat |
| Designation |
Post graduate Student |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7045864434 |
| Fax |
|
| Email |
sharanyaneuro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranjal Grover |
| Designation |
Principal |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619064917 |
| Fax |
|
| Email |
drpranjal.grover@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranjal Grover |
| Designation |
Principal |
| Affiliation |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai.
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9619064917 |
| Fax |
|
| Email |
drpranjal.grover@gmail.com |
|
|
Source of Monetary or Material Support
|
| TMVs Lokmanya Tilak College of Physiotherapy, Kharghar, Navi Mumbai, Maharashtra, India, Pin code 410210. |
|
|
Primary Sponsor
|
| Name |
TMVs Lokmanya Tilak College of Physiotherapy |
| Address |
TMVs Lokmanya Tilak College of Physiotherapy, Department of Neuro Physiotherapy, 3rd floor, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai, Maharashtra, India, pin code 410210. |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Department of Neuro Physiotherapy, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, Navi Mumbai. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharanya Bapat |
TMVs Lokmanya Tilak College of Physiotherapy |
TMVs Lokmanya Tilak College of Physiotherapy, Department of Neuro Physiotherapy, 3rd floor, Tilak Maharashtra Vidyapeeth, J Block, Sector 14, Near Raghunath Vihar, Kharghar, 410210, Navi Mumbai.
Raigarh
MAHARASHTRA |
7045864434
sharanyaneuro@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMVs Lokmanya Tilak College of Physiotherapy, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional protocol
|
Group A:- Conventional Protocol
5 min warmup, Conventional protocol, 10 min cool down
Duration 5 times a week for 4 weeks.
|
| Intervention |
Sensorimotor training |
Group B:- Conventional exercise + Interventional
5 min warm up, TAMBURO method mediated sensorimotor training and 10 min cool down.
5 times a week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
84.00 Year(s) |
| Gender |
Both |
| Details |
Age 65-84 year old male and female with Type II Diabetes Mellitus for more than 1 year.
Walking ability:- should be able to walk freely with or without support.
Berg balance scale score less than equal to 40 ( medium to high risk of fall)
MoCA scale score less than equal to 24 (mild to moderate cognitive impairment) |
|
| ExclusionCriteria |
| Details |
Diagnosis of cardiovascular, rheumatologic, neurologic or musculoskeletal diseases that might interfere with daily life activities.
Use of drugs that might potentially have negative effects on cognition, alertness and psychomotor function (opioids, Antiepileptics, anxiolytic, antipsychotic, hypnotics, sedatives)
Presence of vestibulopathies.
Injuries in lower limb or history of fractures in last 6 months.
Patient with uncontrolled diabetes. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fullerton Advanced Balance Scale
MoCA Scale |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
12/01/2026 |
| 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="1"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This study is a randomized, single blind, parallel group trial to study the effect of 4 week sensorimotor training on balance and cognitive performance in 40 community dwelling elderly within 65-84 years with Type 2 Diabetes Mellitus. Several studies found that aging and diabetes mellitus is accompanied with decline in cognitive and sensorimotor functions due to several physiological and pathological changes. There are very limited studies which shows effect of specific sensorimotor training on balance and cognitive performance in elderly with Type 2 Diabetes Mellitus. Thus the primary outcome to assess balance and cognitive performance in elderly with Type 2 Diabetes Mellitus is Fullerton Advance Balance scale and MoCA scale respectively. |