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

Not Applicable

Conditions: Health Condition 1: G35- Multiple sclerosis

Registration Number: CTRI/2019/10/021482

Lead Sponsor: S Rajan Chellappa

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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)Timepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Balance, Berg Balance Scale (BBS)Timepoint: 6 months;Cognitive function: Paced Auditory Serial Addition Test (PASAT)Timepoint: 6 months;Fatigue: Modified fatigue impact scale. (MFIS)Timepoint: 6 months;Hand function: Nine Hole Peg Test (NHPT).Timepoint: 6 months;Quality of life: Multiple Sclerosis Quality of <br/ ><br>Life - 54 questionnaires (MSQOL-54). <br/ ><br>Timepoint: 6 months