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CTRI Number  CTRI/2019/10/021482 [Registered on: 01/10/2019] Trial Registered Prospectively
Last Modified On: 07/01/2022
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   M-health app for rehabilitation of patients with Multiple Sclerosis. 
Scientific Title of Study   Development and evaluation of a mobile health application (m-health app) for rehabilitation of patients with multiple sclerosis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  S Rajan Chellappa 
Designation  Research Scholar 
Affiliation  Punjabi university Patiala 
Address  Department of Physiotherapy Punjabi university Patiala
Senior Physiotherapist Department of PRM (Physiotherapy) PGIMER Chandigarh
Patiala
PUNJAB
147002
India 
Phone  9876553254  
Fax    
Email  s.rajanchellappa@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Dheeraj Khurana 
Designation  Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Neurology PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087009695  
Fax    
Email  dherajk@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kathirvel S 
Designation  Assitant Professor 
Affiliation  PGIMER Chandigarh 
Address  Department of Community Medicine and School of Public Health PGIMER Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  7087003412  
Fax    
Email  selvkathir@gmail.com  
 
Source of Monetary or Material Support
Modification(s)  
Department of Neurology PGIMER Chandigarh 
 
Primary Sponsor  
Name  S Rajan Chellappa 
Address  Research Scholar Department of Physiotherapy Punjabi university Patiala Senior Physiotherapist Department of PRM (Physiotherapy) PGIMER Chandigarh 
Type of Sponsor  Other [self] 
 
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 
S Rajan chellappa  PGIMER Chandigarh  Room no 3016 Department Neurology Multiple Sclerosis Special clinic
Chandigarh
CHANDIGARH 		 9876553254

s.rajanchellappa@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G35||Multiple sclerosis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mobile health application (m-health app) based rehabilitation for Multiple sclerosis.  Mobile health application (m-health app) based rehabilitation for Multiple sclerosis.To improve muscle weakness, improve endurance, improve coordination / balance, reduce muscle spasticity and education about fatigue management, importance of physical activity and aerobic exercises.  
Comparator Agent  Routine care  Routine care(home exercise program) to improve muscle weakness, improve endurance, improve coordination / balance, reduce muscle spasticity and education about fatigue management, importance of physical activity and aerobic exercises.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Confirmed diagnosis of multiple sclerosis, according to the Mc Donald 2010 criteria.
2 RRMS, with an Expanded Disability Status Scale (EDSS) scores of between 1.0 and 5.0.
3 Clinically stable or relapse free for at least 4 weeks prior to entering the study;
4 Mini Mental Status Examination (MMSE) scores more than 24.
5 Free of contraindications for physical activity (e.g. no underlying cardio-vascular disease, severe pulmonary disease, renal failure);
6 Physician permission to participate in the study.
7 Patients who will provide written informed consent.
8 The patients must have a smartphone with internet facility and should be competent as well as willing to use an app as health care tool. (For Phase Ib (Pilot phase) and Phase II).
 
 
ExclusionCriteria 
Details  1 Patients who are not receiving any Disease Modifying Therapy (DMT), and immunosuppression drugs.
2 Patients with progressive forms of MS (SPMS, PPMS and PRMS) will be excluded.
3 Patients with chronic illness, like TB, HIV, and Hepatitis B & C will be excluded.
4 Currently pregnant;
5 Patients who are localized in poor network connectivity area. (For Phase Ib (Pilot phase) and Phase II).
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gait: Timed 25-Foot Walk (T25FW)   6 months  
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life: Multiple Sclerosis Quality of
Life - 54 questionnaires (MSQOL-54).
 		 6 months 
Hand function: Nine Hole Peg Test (NHPT).   6 months 
Fatigue: Modified fatigue impact scale. (MFIS)   6 months 
Balance, Berg Balance Scale (BBS)   6 months 
Cognitive function: Paced Auditory Serial Addition Test (PASAT)   6 months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/01/2020 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
The aim of this research is to develop and evaluate e a new service delivery tool for providing  rehabilitation in patient with MS. Mobile health may complement or replace center based rehabilitation for patients with MS such as outpatient clinics, especially when access to specialized health services is limited or difficult, and encourage the exercise adherence. This novel approach has the potential to widen access, promote adherence and offer patients an opportunity to exercise in their home environment that too in cost effective manner. This is the first study to apply mobile health technology for rehabilitation in MS patients in India. This study will be carried out in two phases at MS special clinic, Dept. of Neurology, PGIMER, Chandigarh. The first phase  will be carried out in two sub phases i.e. preliminary phase to develop mobile app content and pilot phase is to assess the usability and designing of the final mobile app. The second  phase of the study would be pragmatic, Prospective Randomized Open labeled with Blinded End point assessment (PROBE) design to assess the effectiveness of mobile app in delivering the  rehabilitation. This mobile health application (m-Health app) which is to be developed and evaluated for this research purpose, will deliver education and information about the rehabilitation measures to the patients who are living in the most remote and resource poor settings of the country in a cost effective manner, thus it would effectively tackle the burden of chronic progressive nature of this disease. Findings from this study would make several contributions to the current literature about how mobile health programs can influence access and outcomes for MS patients. In addition, the results of this research work would increases the scope of mobile health in other chronic diseases, and open a new window in health care delivery in India.
 
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