M-health app for rehabilitation of patients with Multiple Sclerosis.

Not yet recruiting

Conditions: Multiple sclerosis,

Registration Number: CTRI/2019/10/021482

Lead Sponsor: S Rajan Chellappa

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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).

Exclusion Criteria

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).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gait: Timed 25-Foot Walk (T25FW)	6 months

Secondary Outcome Measures

Name	Time	Method
Quality of life: Multiple Sclerosis Quality of	Life - 54 questionnaires (MSQOL-54).
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

Trial Locations

Locations (1): PGIMER Chandigarh
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER Chandigarh
🇮🇳Chandigarh, CHANDIGARH, India
S Rajan chellappa
Principal investigator
9876553254
s.rajanchellappa@yahoo.co.in