Physical Telerehabilitation in Multiple Sclerosis

NCT ID: NCT03230903

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2020-09-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Home Telerehabilitation

The physical telerehabilitation group will receive an exercise plan, exercise equipment, a computer, and access to a daily individualized exercise plan. Participants in this group will follow the exercise plan that is sent to their computer via the telerehabilitation software. Participants will have interactions with a physical therapist and an exercise physiologist throughout training intervention.

Group Type: EXPERIMENTAL

Home telerehabilitation

Intervention Type: OTHER

Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.

Usual Care

The usual care group will receive an individualized exercise program at baseline however participants will not receive the home telerehabilitation system or exercise equipment. Participants assigned to the usual care group will also not have access to the study physical therapist or exercise physiologist during the intervention.

Group Type: SHAM_COMPARATOR

Usual Care

Intervention Type: OTHER

Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.

Interventions

Home telerehabilitation

Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.

Intervention Type: OTHER

Usual Care

Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Joel Stein, MD

Simon Baruch Professor of Physical Medicine & Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joel Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

MS150167

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AAAQ7693

Identifier Type: -

Identifier Source: org_study_id