| CTRI Number |
CTRI/2024/08/072189 [Registered on: 08/08/2024] Trial Registered Prospectively |
| Last Modified On: |
07/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of synchronous and asynchronous models of tele-rehabilitation for Parkinson’s disease patients |
|
Scientific Title of Study
|
Comparison of synchronous and asynchronous tele-rehabilitation for individuals with Parkinson’s disease at a tertiary care centre |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiv Priya |
| Designation |
PhD Student |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy
Punjabi University
NH 64, next to Urban Estate Phase II, Patiala, Punjab
Patiala
PUNJAB
147002
India |
| Phone |
8146874555 |
| Fax |
|
| Email |
shivneuro@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sandeep Singh |
| Designation |
Assistant Professor |
| Affiliation |
Punjabi University, Patiala |
| Address |
Department of Physiotherapy
Punjabi University
NH 64, next to Urban Estate Phase II, Patiala, Punjab
Patiala
PUNJAB
147002
India |
| Phone |
9417802490 |
| Fax |
|
| Email |
sandyraina24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sahil Mehta |
| Designation |
Additional Professor |
| Affiliation |
Post Graduate Institute of Medical Education & Research (PGIMER) |
| Address |
Department of Neurology
Postgraduate Institute of Medical Education & Research, Sector-12, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9815543539 |
| Fax |
|
| Email |
mehtasahilpgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education & Research(PGIMER), sector-12 Chandigarh, Pin- 160012, India. |
|
|
Primary Sponsor
|
| Name |
Shiv Priya |
| Address |
Punjabi University,
Department of Physiotherapy
NH 64, next to Urban Estate Phase II, Patiala, Punjab Pin- 147002, India. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sahil Mehta |
Postgraduate Institute of Medical Education & Research |
Department of Neurology, Ground floor, Nehru Hospital ,Sector-12, Chandigarh Pin- 160012, India.
Chandigarh
CHANDIGARH |
9815543539
mehtasahilpgi@gmail.com |
| Dr Sandeep Singh |
Punjabi University |
Department of Physiotherapy, First floor, Patiala, Punjab Pin- 147002, India
Patiala
PUNJAB |
9417802490
sandyraina24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Punjabi University,Patiala |
Approved |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G20||Parkinsons disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Asynchronous tele-rehabilitation |
In Addition to PE,ED,EB and EDr includes Exercise Video sent to Participants, WhatsApp message reminder, feedback to patient through telephonic call. Exercises based on this protocol have 3 sessions/Week for 10 weeks. Total exercise sessions will be 30 and total duration of intervention will be 10 weeks. . Assessment will be taken at baseline before interventions and after 10 weeks of interventions. |
| Intervention |
Conventional Home Based Rehabilitation |
Patient Education(PE)
Exercise Demonstration(ED)
Exercise Booklet(EB)
Exercise Diary maintenance(EDr)
Exercises based on this protocol have 3 sessions/Week for 10 weeks. Total exercise sessions will be 30 and total duration of intervention will be 10 weeks. Assessment will be taken at baseline Before interventions and after 10 weeks of interventions |
| Comparator Agent |
Synchronous tele-rehabilitation |
In Addition to PE,ED,EB and EDr includes similar physiotherapy exercise as performed by participants in residence through Live WhatsApp Video call under supervision of Physiotherapist. Exercises based on this protocol have 3 sessions/Week for 10 weeks. Total exercise sessions will be 30 and total duration of intervention will be 10 weeks. Assessment will be taken at baseline before interventions and after 10 weeks of interventions. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient diagnosed with Parkinson’s disease as per United Kingdom Parkinson’s disease society brain bank clinical diagnostic criteria confirmed by the Neurologist.
2.Hoehn and Yahr classification stage - stage 1 to stage 3.
3 Has been receiving a stable dose of Antiparkinsonian medication in the previous 3 months.
4.Availability of technical instrumentation for remote Video call (Smart phone) and ability to use them by patients and/or caregiver.
5.Availability of a caregiver during tele-rehabilitation sessions for patients with Hoehn and Yahr score more than 1.
6.Mini Mental Status Examination (MMSE) scores more than 24.
|
|
| ExclusionCriteria |
| Details |
1.Patients diagnosed with Parkinson’s plus syndromes or drug- induced Parkinsonism will be excluded.
2.Had brain surgery in the past including implanted deep brain-stimulation.
3.Presence of medical/musculoskeletal conditions that would limit safe participation in an exercise program (e.g. no underlying cardio-vascular disease, severe pulmonary disease, renal failure, total knee replacement, total hip replacement).
4.Patients who are localized in poor network connectivity area
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
MDS-UPDRS-Part3
Berg balance scale
Time-up and Go test
Parkinson’s disease Questionnaire-39
|
Data will be recorded at baseline before intervention and at end of 10th week after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Telehealth Usability Questionnaire
|
Data will be recorded at baseline before intervention and at end of 10th week after intervention |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
23/09/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Parkinson’s disease (PD) is a
progressive neurodegenerative condition, causing impairments primarily in the
motor system. There is increase in burden of Parkinson’s disease, due to
increase life expectancy of individual with PD (improved medical facilities)
leading to longer disease duration. Also, growing industrialization causes more
use of pesticides, solvents and metals leads to increase incidence and
prevalence of PD.
There
is enormous supportive scientific evidence that established important role of
physiotherapy in PD. However many barriers are recognized in utilization of
in-person physiotherapy services by individuals with PD like cost of
transportation and lack of physiotherapy services in vicinity. This calls for
urgent need of alternate models of rehabilitation and in this regard
tele-rehabilitation seems to be very viable option for rehabilitation of
individuals with PD.
Individuals with PD, form an optimal target population
for tele-rehabilitation because they require long–term rehabilitation and
tele-rehabilitation will help to prevent discontinuity in continuum of care
during outpatient rehabilitative phase.
Depending upon the tool used in tele-rehabilitation, it can be classified as
synchronous (i.e., interaction between therapist and patient at the real time,
through audio and video calls), or asynchronous (i.e., interactions between
therapist and patient do not occur in real time). So, present study intends to
investigate and compare effectiveness of synchronous and asynchronous model of
tele-rehabilitation for individuals with Parkinson’s disease. |