| CTRI Number |
CTRI/2022/09/045822 [Registered on: 23/09/2022] Trial Registered Prospectively |
| Last Modified On: |
21/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Mobile based application for tele-rehabilitation of older adults with primary Insomnia |
|
Scientific Title of Study
|
Mobile-based application for telerehabilitation of older adults with primary insomnia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel
Raigarh
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajani Mullerpatan |
| Designation |
Professor Director |
| Affiliation |
MGM School of Physiotherapy MGM Institute of Health Sciences |
| Address |
MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel
MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel
MAHARASHTRA
410209
India |
| Phone |
02227437866 |
| Fax |
|
| Email |
rajani.kanade@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Institute of Health Sciences-infrastructure and material support |
|
|
Primary Sponsor
|
| Name |
MGM Institute of Health Sciences |
| Address |
MGM Educational Campus Plot no 1 and 2 Kamothe Taluka Panvel District Raigad 410209 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajani Mullerpatan |
MGM School of Physiotherapy MGM Institute of Health Sciences |
MGM School of Physiotherapy OPD 2nd floor room no 55 MGM Hospital Kamothe Plot no 1 and 2 Navi Mumbai Taluka Panvel
410209
Raigarh
MAHARASHTRA |
09920048476
rajani.kanade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Research on Human Subjects of Mahatma Gandhi Missions Institute of Health Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G89-G99||Other disorders of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Supervised Physiotherapy Exercise
|
Participant education using informative booklets and Aerobic training, strength training, balance training and pelvic floor strengthening and cognitive training for 12 weeks, 6 days a week
|
| Intervention |
Telerehab Exercise Intervention |
Participant education using informative booklets and Aerobic training, strength training, balance training and pelvic floor strengthening and cognitive training for 12 weeks, 6 days a week. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Older adults able to read, hear, understand and follow the visual data and auditory data. Older adults with controlled hypertension and controlled diabetes. |
|
| ExclusionCriteria |
| Details |
Older adults with a history or current manifestations of Cardiopulmonary diseases, Stroke, Parkinson’s, Multiple sclerosis, Myasthenia gravis, Neuromuscular diseases, Encephalitis, Amyotrophic lateral sclerosis,
Dementia, Alzheimer’s disease, Spinal cord injury, Ataxia, Brain tumors, Cerebral aneurysm, Epilepsy and Seizures, Guillain barre syndrome, Head injuries, Meningitis, Cancer, any Systemic malfunction, Physical disabilities, Spinal disc
herniation or dislocation & fractures will be excluded.
These medical conditions will make it difficult for elderly people to physically operate the mobile based application as well as to read, understand and follow the visual and auditory data. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in the older adult
2.Polysomnography
3. Development of final version of the mobile application |
The Pittsburgh Sleep Quality Index (PSQI) and Polysomnography : Baseline: 1-4 months and post intervention: 15-18 months
Development of final version of the mobile application: 13-14 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Knowledge, attitude and belief survey, Timed up and go, 30 seconds chair stand test, Functional reach test, arm curl test,Incontinence Impact Questionnaire (IIQ-7) and Urinary distress short form (UDI-6), chair sit and reach, mini cog scale, 6 minute walk test |
Knowledge, attitude and belief survey: 1-4 months
Timed up and go, 30 seconds chair stand test, Functional reach test, arm curl test,Incontinence Impact Questionnaire (IIQ-7) and Urinary distress short form (UDI-6), chair sit and reach, mini cog scale, 6 minute walk test: Baseline: 1-4 months, post intervention: 15-18 months
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
19/11/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· Aim: To create awareness about physiotherapy and self-empowerment of older adults to improve sleep quality and for maximization of physical function through mobile-based application for tele-rehabilitation. Objectives: • To maximize functional level and self-empower elderly for independent living. • To implement the concept of geotechnology for rehabilitation of Indian older adults. • To check the effectiveness of long-term comprehensive exercise program on sleep quality and physical functioning in elderly.
Summary of the proposed research: This research aims at creating awareness about physiotherapy and self-empowerment of older adults to improve sleep quality and for maximization of physical function through mobile based application for tele-rehabilitation. In India, Insomnia is a common but under recognized problem in the elderly population and is reported to have multiple negative health correlates. Hence the public health burden of insomnia is significant given greater odds of hospitalization, use of home health care services, and nursing home use. In situations, like the current Covid 19 pandemic, tele-rehabilitation provides an excellent opportunity to provide a continuum of care, monitoring of daily vitals and enhance the exercise regime to improve the sleep quality and also simultaneously improve balance, strength, flexibility and aerobic capacity in older adults. |