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
|
|
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
|
|
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
|
|
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
- 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 - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included Yes).
- 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.
- 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. |