Physical Telerehabilitation in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230903
• Other study ID #: AAAQ7693
• Secondary ID: MS150167
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: September 2020

Study information

• Verified date: February 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• 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.
• Usual Care
Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory fitness	Cardiorespiratory fitness will be measured by oxygen consumption	Baseline up to 6 months
Secondary	MS Self-efficacy scale	MS Self-efficacy scale is a 14-point questionnaire designed to assess the psychological adjustment and quality-of-life of individuals with MS.	Baseline up to 6 months
Secondary	Exercise adherence	Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.	Baseline up to 6 months
Secondary	Center for Epidemiologic Studies Depression Scale (CES-D)	The CES-D is a 20 point questionnaire based on self-reported frequency of symptoms related to depression during the past week.	Baseline up to 6 months
Secondary	Berg Balance Scale (BBS)	BBS is a clinical 14-item scale designed to measure balance	Baseline up to 6 months
Secondary	2-Minute Walk Test (2MWT)	Total distance walked in meters will be recorded.	Baseline up to 6 months