| CTRI Number |
CTRI/2025/08/093659 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
23/08/2025 |
| Post Graduate Thesis |
No |
| 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 Sensorimotor Exercise on Back Function in People with Type 2 Diabetes |
|
Scientific Title of Study
|
Effect of Sensorimotor Exercises in Type 2 Diabetes Mellitus Participants Having Impaired Lumbar Proprioception |
| 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 Monika Rani |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Punjab |
| Address |
Dapartment of Physiotherapy, Chitkara School of Health Sciences
Patiala
PUNJAB
140401
India |
| Phone |
7988047014 |
| Fax |
|
| Email |
monikarani802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Rani |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Punjab |
| Address |
Dapartment of Physiotherapy, Chitkara School of Health Sciences
Patiala
PUNJAB
140401
India |
| Phone |
7988047014 |
| Fax |
|
| Email |
monikarani802@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Rani |
| Designation |
Assistant Professor |
| Affiliation |
Chitkara School of Health Sciences, Chitkara University, Punjab |
| Address |
Dapartment of Physiotherapy, Chitkara School of Health Sciences
Patiala
PUNJAB
140401
India |
| Phone |
7988047014 |
| Fax |
|
| Email |
monikarani802@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chitkara University, Rajpura, Punjab, India, 140401 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Monika Rani |
Kyna Intelligence Rehab |
Room no 1, Department of Physiotherapy, Rajpura, Punjab
Patiala
PUNJAB |
7988047014
monikarani802@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Chitkara University Punjab |
Approved |
| Institutional Human Ethical Committee Chitkara University Punjab |
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 |
| Comparator Agent |
Control Group |
lumbar range of motion exercises will be given for approximate 40 minutes per day, 5 times a week for 4 weeks |
| Intervention |
Sensorimotor Exercise |
sensorimotor exercises that included hollowing exercises, single leg raising in the quadruped position, contralateral arm and leg raising in the quadruped position, abdominal bracing, holding a bridging position, single leg raising in the bridging position. The treatment will be given for almost 40 minutes per day, 5 times a week for 4 week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants having Type 2 Diabetes Mellitus
Participants having HbA1c level 6.8 or more
Participants having an age group of 18 to 60 year
Participants having impaired lumbar proprioception
|
|
| ExclusionCriteria |
| Details |
Participants suffering from other type of diabetes like juvenile diabetes mellitus or type 1 diabetes mellitus.
Participants who are having other condition which causes impaired lumbar proprioception e.g. low back pain
Participants having any back and leg surgery from the last 1 year.
Participants having serious illness like chronic kidney disease, chronic heart disease,
systematic fever greater than 6 month
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lumbar Proprioception |
0 week, 4th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Numeric Pain Rating Scale, Oswestry Disability Index |
Baseline, after 4th week |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - Online
- For how long will this data be available start date provided 01-09-2025 and end date provided 01-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Brief
Summary
Background
and Purpose of Trial
Diabetes
Mellitus is the most prevalent disorder now a days. There are so many macro and
microvascular complications are associated with Diabetes mellitus. Out of which
one microvascular complication is diabetes neuropathy. Due to diabetic
neuropathy, there is chances of risk of fall, gait deviation and proprioception
deficit in the patients. Therefore, this study aimed to find out the
prevalence rate of lumbar proprioception deficit among type 2 diabetes mellitus
and to find out the effect of sensorimotor exercises on improving lumbar
proprioception in type 2 diabetes mellitus.
Methodology
A
total of 200 participants with type 2 diabetes mellitus were included in the
study to find out the prevalence rate of lumbar proprioception deficit. After
the prevalence rate is found in order to find out the effect of sensorimotor
exercise on improving the lumbar proprioception in type 2 diabetes mellitus,
participants with impaired lumbar proprioception were randomly assigned and
divided into two groups. Group A received Sensorimotor exercises and Group B
received normal Lumbar ROM exercises. The two groups with impaired lumbar
proprioception received their own treatment five times per week, for four
weeks, for 40 minutes each time. Changes in pain and functional performance
evaluation were examined by the numeric pain rating scale for pain and Oswestry
Disability Scale for functional disability and lumbar range of motion for
lumbar proprioceptive deficit. |