Health Condition 1: G35- Multiple sclerosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gait: Timed 25-Foot Walk (T25FW)Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 Life - 54 questionnaires (MSQOL-54). Timepoint: 6 months | — |
Countries
India
Contacts
PGIMER Chandigarh