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CTRI Number  CTRI/2021/01/030443 [Registered on: 13/01/2021] Trial Registered Prospectively
Last Modified On: 05/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   EFFECT OF SENSORY TRAINING AND VIRTUAL REALITY TRAINING (EAD-MOUNTED DISPLAY) FOR BALANCE, QUALITY OF LIFE AND RISK OF FALL IN ELDERLY WITH DIABETIC NEUROPATHY. 
Scientific Title of Study   EFFECTIVENESS OF SOMATOSENSORY TRAINING AND VIRTUAL REALITY TRAINING FOR BALANCE, QUALITY OF LIFE AND RISK OF FALL IN ELDERLY WITH DIABETIC NEUROPATHY- A RANDOMIZED CLINICAL TRIAL. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manisha S Awate 
Designation  MPT Student 
Affiliation  KLE Institute of Physiotherapy, Belagavi 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy Geriatrics Physiotherapy Department Nehru Nagar Belgaum Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9019552898  
Fax    
Email  manishaawate211@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Anil Rachappa Murgod 
Designation  Associate Professor and Head of Geriatric Physiotherapy Department 
Affiliation  KLE Institute of Physiotherapy, Belagavi 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy Geriatrics Physiotherapy Department Nehru Nagar Belgaum Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9448334248  
Fax    
Email  anilmurgod@klekipt.edu.in  
 
Details of Contact Person
Public Query
 
Name  Anil Rachappa Murgod 
Designation  Associate Professor and Head of Geriatric Physiotherapy Department 
Affiliation  KLE Institute of Physiotherapy, Belagavi 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy Geriatrics Physiotherapy Department Nehru Nagar Belgaum Belgaum KARNATAKA 590010 India

Belgaum
KARNATAKA
590010
India 
Phone  9448334248  
Fax    
Email  anilmurgod@klekipt.edu.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  KLE Institute of Physiotherapy 
Address  KLE Institute of Physiotherapy, JNMC campus, Nehru Nagar, Belagavi 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Manisha S Awate  Physiotherapy OPD no- 39, KLEs Dr. Prabhakar Kore Charitable Hospital, Belagavi- 590010  Room no- 21, Geriatrics Department, 39-OPD, KLEs Dr. Prabhakar Kore Charitable Hospital Nehru Nagar Belgaum KARNATAKA
Belgaum
KARNATAKA 
9019552898
-
manishaawate211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KLE Institutional Research and Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G64||Other disorders of peripheral nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Somatosensory Training   First day of treatment baseline outcomes measures- Michigan Neuropathy Scoring Scale, CASP-19 for quality of life, berg balance scale and Fall efficacy scale will be done. Somatosensory training group- Duration: 45 minutes of treatment will be given twice a week for six weeks. The sessions will be divided into three phases: warm up and stretching (10mins), somatosensitive training (30mins) and cool down (5mins) with breathing exercises. It will be considered of the training that will consist 13 stations with different textures. Participant will be instructed to stand on each texture for 2mins at. At the first session of the treatment and at the last session treatment, outcome measures will be recorded of both the groups.  
Intervention  Virtual Reality Training group with head mounted display.  Virtual reality training group- Duration: 45 minutes of treatment will be given twice a week for six weeks. The sessions will be divided into three phases: warm up and stretching (10mins), virtual reality training (30mins) and cool down (5mins) with breathing exercises. It will be provided by the means of head mounted display (oculus go stand lone). Head mounted display consist of gyroscope, an accelerometer and a magnetometer all to track head orientation. Game challenges will include weight shifting from side to side, changing direction, running on the spot and jumping. At the first session of the treatment and at the last session treatment, outcome measures will be recorded of both the groups. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Subjects diagnosed with diabetes.
2. Subjects coring 7-10 using Michigan Neuropathy scoring scale.
3. Subjects scoring 21-40 by using berg balance scale
 
 
ExclusionCriteria 
Details  1.Diagnosed cases of neuromuscular conditions like stroke, spinal cord injuries and traumatic brain injury.
2.Subjects with vestibular disorder.
3.Subjects with presence of lower limb lesions or fractures in the last 6 months.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Michigan Neuropathy Scoring Scale  Initially at baseline  
 
Secondary Outcome  
Outcome  TimePoints 
Bergs balance scale  Initially at baseline and then after the study is
over which is after 6 weeks 
CASP-19 (QUALITY OF LIFE)  Initially at baseline and then after the study is
over which is after 6 weeks
 
Fall efficacy scale (FES-I)  Initially at baseline and then after the study is
over which is after 6 weeks
 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/01/2021 
Date of Study Completion (India) 16/05/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
under process of publishing 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included Yes).

  6. For how long will this data be available start date provided 15-12-2020 and end date provided 01-04-2021?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  

Diabetes is a common metabolic disease having serious implication and its incidence is increasing day by day. According to study done in 2013 on global estimation of diabetes, 60% of total population of Asia has diabetes. The complications of diabetes increases with the age. One of the many complications of diabetes mellitus is diabetic neuropathy. The prevalence of diabetic neuropathy varies from 10% within 1 year of diagnosis of diabetes to 50% in patients with diabetes for more than 25 years. 

The mechanism underlying diabetic neuropathy are multiple and involves several interrelated metabolic abnormalities subsequent to hyper-glycaemia and insulin and C-peptide deficiencies. And causes of peripheral neuropathy is nerve damage instigated by glucose toxicity.  Diabetic neuropathy encompasses a group of clinical and subclinical syndromes each characterized by diffused or focal damage to peripheral somatic or autonomic nerve fibres. The clinical syndromes of diabetic neuropathy affects nervous system and go undiagnosed while exercising its ravages. Although symptoms are non-specific and mimic of several different conditions. There is increase in production of advanced glycosylation end products. These end products alter the structure of the protein and its metabolism, vascular and platelet function and modifies growth factor release. All these compounds are produced in larger amounts in diabetes that paly a very important role in the development of diabetic neuropathy. This entire process is associated with aging.

Diabetic neuropathy has been associated with a high risk of falls in elderly individuals. In addition, individuals with diabetic neuropathy have also been reported to have five times greater ankle proprioceptive threshold. During walking, individuals with diabetic neuropathy exhibit reduced ankle muscle strength and speed which impairs postural stability and increases the risk of subsequent falls. Balance rehabilitation/training is, therefore, an important aspect of the clinical management of diabetic foot disease, especially to improve postural stability and reduce the risk of falling. The current strategies include instrumental balance training programs, including dynamic platforms and powered platforms.

 A recent review of the effect of these various interventions on balance in diabetes reported exercise to be the most promising in treating balance dysfunction. A significant amount of research has focused on balance improvement and fall prevention through different programs in older adults. Each of these methods has created an impact on the infrastructure of balance to improve performance. 

Therefore, the aim of the study is to compare the effectiveness of somatosensory training and virtual reality training for balance, quality of life and risk of fall in elderly with diabetic neuropathy.

 
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