| CTRI Number |
CTRI/2024/09/073501 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
03/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of vestibular exercises on balance, walking and fall risk in participants with Type 2 Diabetes of vadodara,Gujarat |
|
Scientific Title of Study
|
Effect of multimodal vestibular rehabilitation exercises on postural control, gait and risk of fall in patients with Type 2 Diabetes Mellitus of vadodara,Gujarat |
| 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 Fatema Daruwala PT |
| Designation |
PhD Scholar (Gujarat University) |
| Affiliation |
Drs. Kiran and pallavi patel Global University |
| Address |
Physiotherapy Department
Vadodara Mumbai NH 8, Varnama,Gujarat
Vadodara Mumbai NH 8, Vadodara, Gujarat 391240
Vadodara
GUJARAT
390019
India |
| Phone |
|
| Fax |
|
| Email |
fatydaruwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nehal Shah |
| Designation |
I/C principal and PhD Guide |
| Affiliation |
SBB College of Physiotherapy |
| Address |
SBB College of Physiotherapy,
Medical College building,
VS Hospital,
Ellis Bridge,
Ahmedabad
Physiotherapy department
VS Hospital,
Ellis Bridge,
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9662302606 |
| Fax |
|
| Email |
nehalshah75@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nehal Shah |
| Designation |
I/C principal and PhD Guide |
| Affiliation |
SBB College of Physiotherapy |
| Address |
SBB College of physiotherapy
Medical College building,
VS Hospital,
Ellis Bridge,
Ahmedabad
Physiotherapy Department
VS Hospital,
Ellis Bridge,
Ahmedabad
Ahmadabad
GUJARAT
380006
India |
| Phone |
9662302606 |
| Fax |
|
| Email |
nehalshah75@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Fatema Daruwala PT |
| Address |
Vadodara Mumbai NH8, Vadodara, Gujarat, India Pin code : 391240 |
| 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 Dharmesh Contractor |
Matrusri davalba ayurved hospital |
Room no - 14
Department - Physiotherapy opd,
Division- First floor
Vadodara Mumbai NH 8 Varnama, Vadodara 391243 Gujarat
Vadodara
GUJARAT |
9879963156
dharmeshcontractor.kspr@kpgu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Biomedical and Health Research, KPGU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multimodal Vestibular Rehabilitation Exercises |
Intervention will be given 3 times in a week for 4 weeks (Total 12 sessions)
Eye movements, head movements Shoulder movements Dynamic movements including sit to stand, one leg standing Tandem walking, Heel walking, toe walking, Walking across the room, walking up and down the slope. Exercises will be done by modification in base of support, Wrist and ankle weight cuffs. |
| Comparator Agent |
Standard Exercise protocol |
Intervention will be given for 3 times a week for 4 weeks (Total 12 sessions)
ROM exercises of bilateral ankle joints, sit to stand exercises, Standing weight shifts, Bilateral heel raises, one leg standing, marching |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Type2 DM (with controlled blood glucose level) with vestibular dysfunction identified by mCTSIB
2.Age 30 to 60 years
3.Able to walk without assistive device
4.Both male and female
|
|
| ExclusionCriteria |
| Details |
1.Any other significant Cardiopulmonary, neurological (hemiparesis, myelopathy etc) or lower limb orthopedic (amputation, fracture etc) impairments
2.Clear causes of inner ear injury,BPPV, Vestibular neuritis etc
3.Presence of nephropathy,retinopathy, neuropathy (Screened out by Michigan neuropathy scale)
4.Cervical neurological symptoms (radiculopathy, myelopathy, etc), limited ROM of neck, cervical spine instability,history of neck surgery, recent neck trauma
5.Those not willing to participate
6.Those unable to comprehend the command
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mCTSIB (Modified Clinical test of Sensory interaction in Balance), DGI (Dynamic Gait Index) |
mCTSIB (Modified Clinical test of Sensory interaction in Balance), DGI (Dynamic Gait Index) will be evaluated at baseline and at the end of 4 weeks intevention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ABC (Activities specific balance confidence scale) |
ABC Scale will be taken at baseline and at the end of 4 weeks 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)
|
17/09/2024 |
| 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 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 - NO
|
|
Brief Summary
|
Diabetes mellitus is chronic metabolic condition characterized by elevated blood glucose level which may result from inability of body to produce insulin, resist insulin action or both.Patients with diabetes have higher incidence of vestibular dysfunction which may increase the risk of fall and it could be an independant mediator of association between diabetes and falls. Need of study : Routinely type 2 Diabetes patients are managed by aerobic training, fitness training and advice on diet management.There is paucity of studies that focus on vestibular dysfunction and simultaneous management of all three sensory input systems, sensory interaction, modification of base of support, cognition and other motor dysfunctions in patients with diabetes without neuropathy. Research question : 1) What is the prevalence of vestibular dysfunction in type 2 diabetes? 2) will 4 weeks of Multimodal Vestibular Rehabilitation protocol be effective in type 2 Diabetes patients? In this study prevalence of vestibular dysfunction in type 2 Diabetes mellitus will be evaluated. Patients of type 2 DM with vestibular dysfunction will be divided in two groups Group 1 : Multimodal Vestibular Rehabilitation Exercises Group 2 : Standard Exercise Protocol. Outcome measures will be evaluated at baseline and at the end of 4 weeks intervention. |