Clinical trial NCT03230903: Physical Telerehabilitation in Multiple Sclerosis
Official title: Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Telerehabilitation
Physical rehabilitation
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2017-07-27
Enrollment: 78
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study aims to evaluate the efficacy of the MS HAT (Multiple Sclerosis Home Automated Telemanagement) System as an adjunct to the current standard of medical care for patients with MS (PwMS). The individual patient with MS will be the unit of analysis. For each participant, the investigators will assess the effect of Home Automated Telemanagement (HAT) on functional outcomes, levels of disablement including impairment, activity and participation, socio-behavioral parameters, and satisfaction with medical care as described below.

Detailed description: People with multiple sclerosis may develop severe disability over the time. Physical therapy including regular exercise helps patients with severe disability to maintain muscle strength, reduce disease symptoms and improve quality of life. However physical therapy programs at clinical settings require constant travel which may limit access of patients with mobility disability to these services on continuous basis.Technology can allow patients with mobility disability exercise at home under supervision of their rehabilitation team. Currently it is unclear how effective this approach is. The study aims to demonstrate that the patients who were helped by the new technology to exercise at home will have better fitness, less symptoms and better quality of life. If so, other patients with significant mobility disability will be able to take advantage of this technology. This approach can be extended to people with different diseases causing mobility impairment and it can be used not only for physical but also for cognitive and occupational rehabilitation.

Eligibility criteria: Inclusion Criteria:

* Age \>21
* Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria
* EDSS range 5.0-8.0
* Mini-Mental State Examination (MMSE) \> 22 or presence of a caregiver to assist in daily exercise regimen

Exclusion Criteria:

* Coronary artery disease
* Congestive Heart Failure
* Uncontrolled hypertension
* Epilepsy
* Pacemaker or implanted defibrillator
* Unstable fractures or other musculoskeletal diagnoses

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: MS Self-efficacy scale
timeFrame: Baseline up to 6 months
measure: Exercise adherence
timeFrame: Baseline up to 6 months
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Baseline up to 6 months
measure: Berg Balance Scale (BBS)
timeFrame: Baseline up to 6 months
measure: 2-Minute Walk Test (2MWT)
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Joel Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: