| CTRI Number |
CTRI/2026/02/102894 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| 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
|
Effect Of Electrical Stimulation Of The Legs On Blood Sugar Levels And Quality Of Life In Elderly People With Movement Difficulty |
|
Scientific Title of Study
|
Effect Of Lower Limb Neuromuscular Electrical Stimulation NMES On Glycemic Control And Quality Of Life In Mobility Limited Older Adults With Diabesity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEKALA SUPRIYA |
| Designation |
Post Graduate Student |
| Affiliation |
Durgabai Deshmukh Hospital And Research Centre |
| Address |
26Q7C Vidyanagar Adikmet Osmania University Road Hyderabad Telangana India
Hyderabad
TELANGANA
500044
India |
| Phone |
8919304231 |
| Fax |
|
| Email |
supriyamekala273@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MEKALA SUPRIYA |
| Designation |
Post Graduate Student |
| Affiliation |
Durgabai Deshmukh Hospital And Research Centre |
| Address |
26Q7C Vidyanagar Adikmet Osmania University Road Hyderabad Telangana India
Hyderabad
TELANGANA
500044
India |
| Phone |
8919304231 |
| Fax |
|
| Email |
supriyamekala273@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N SIVA JYOTHI |
| Designation |
Associate Professor |
| Affiliation |
Durgabai Deshmukh Hospital And Research Centre |
| Address |
26Q7C Vidyanagar
Adikmet Osmania University Road Hyderabad Telangana India.
Hyderabad
TELANGANA
500044
India |
| Phone |
9866176055 |
| Fax |
|
| Email |
sivajyothimpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| MEKALA SUPRIYA
Durgabai Deshmukh College Of Physiotherapy 26Q7C Vidyanagar Adikmet Hyderabad Telangana
|
|
|
Primary Sponsor
|
| Name |
MEKALA SUPRIYA |
| Address |
26Q7C Vidyanagar Adikmet Hyderabad Telangana 500044 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 MEKALA SUPRIYA |
Durgabai Deshmukh hospital and Research centre |
Durgabai Deshmukh Hospital Out Patient DEPT Of Physiotherapy Ground Floor Block 1 26Q7C Vidya Nagar Adikmet Osmania
University Road Hyderabad Telangana 500044
Hyderabad
TELANGANA |
8919304231
supriyamekala273@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Durgabai Deshmukh Hospital And Research Centre |
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 |
Group B Conventional physiotherapy |
Ankle Pumps
Heel Slides
Knee Extension In Sitting
Single Leg Raise
Lower Limb Stretching
|
| Intervention |
Group A Neuromuscular Electrical Stimulation |
Neuromuscular Electrical Stimulation
Mode Of Application Surface Electrodes
Frequency 30hertz
Pulse Width 300
Duration 30 min.
Rest Time 30sec
3 Days a Week For 4 Weeks
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diabesity Aged 60-80 years
Diagnosed T2DM More Then 5 Years
Random Blood Sugar-100mgperdl And Above
Both Male And Female
No Acute Infection Or Recent Surgery
Willingness To Participate |
|
| ExclusionCriteria |
| Details |
Known Pulmonary Diseases
Cardiac Or Neurological Disorders
History Of Smoking Or Alcohol Abuse
Peripheral Arterial Disease
Amputees |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Random Blood Glucose Level By Using Glucometer
|
Pre Assessment Before Treatment And Post Assessment After 4 Weeks Of Intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality Of Life Short Form 12 Questionnaire |
Pre Assessment Before Treatment And Post Assessment After 4 Weeks Of Intervention
|
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="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
|
The Purpose Of The Study Is To Evaluate The Effect Of Lower Limb Neuromuscular Electrical Stimulation NMES On Glycemic Control And Quality Of Life In Mobility Limited Older Adults With Diabesity . This Is An Experimental Randomised Control Study With Sample Size Of 40 .This Study Is Randomised Into Two Groups 20 Participates In Each Group Using Simple Random Sampling Technique. Group A Will Receive NMES . Group B Will Receive Conventional Physiotherapy Includes Ankle Pumps Heel Slides Knee Extension Abduction And Adduction For Hip In Supine And Lower Limb Stretching. Both Groups Will Receive Treatment For 30 Min Per Session For 3 Days A Week For 4 Weeks. Outcomes Included Are Blood Glucose Level With Glucometer And Quality Of Life With Short Form 12 Questionnaire Which Are Measured At Base Line And After 4 Weeks Of Treatment. |