Multiple SclerosisNCT03230903
Physical Telerehabilitation in Multiple Sclerosis
A study testing Home telerehabilitation in people with Multiple Sclerosis, run by Columbia University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Home telerehabilitation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Coronary artery disease
- Congestive Heart Failure
- Uncontrolled hypertension
- Epilepsy
- Pacemaker or implanted defibrillator
- Unstable fractures or other musculoskeletal diagnoses
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment
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.
Read the 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
- Being tested
- Home telerehabilitation, Usual Care
- Keywords
- Multiple Sclerosis, Telerehabilitation, Physical rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home telerehabilitationOther
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 CareOther
Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.
| Study group | Role | What they receive |
|---|---|---|
| Home Telerehabilitation | Experimental | 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. Receives: Other: Home telerehabilitation |
| Usual Care | Sham comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory fitness
Cardiorespiratory fitness will be measured by oxygen consumption
Measured: Baseline up to 6 months
Secondary outcomes (5)
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.
Measured: Baseline up to 6 months
Exercise adherence
Exercise adherence will be measured by the number of sessions completed by the participant out of the number of exercise sessions prescribed.
Measured: Baseline up to 6 months
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.
Measured: Baseline up to 6 months
Berg Balance Scale (BBS)
BBS is a clinical 14-item scale designed to measure balance
Measured: Baseline up to 6 months
2-Minute Walk Test (2MWT)
Total distance walked in meters will be recorded.
Measured: Baseline up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study startOct 2016
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Joel Stein, MD, Columbia University
- Investigators
- Joel Stein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230903
- Sponsor's protocol ID
- AAAQ7693
- Other IDs
- MS150167
- Status last verified
- Feb 2021
- First submitted
- 4 Jan 2017
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Telerehabilitation in Patients With Multiple Sclerosis With Significant Mobility Impairment
- ClinicalTrials.gov ID
- NCT03230903
- Acronym / sponsor ID
- AAAQ7693
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Telerehabilitation, Physical rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2016
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home Telerehabilitation | Experimental | Other: Home telerehabilitationThe 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. |
| Usual Care | Sham comparator | Other: Usual CareThe 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Coronary artery disease
- Congestive Heart Failure
- Uncontrolled hypertension
- Epilepsy
- Pacemaker or implanted defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home telerehabilitationPatients 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. | Other | Home Telerehabilitation |
| Usual CarePatients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care. | Other | Usual Care |
Primary outcome
Cardiorespiratory fitness
Time frame: Baseline up to 6 months
Cardiorespiratory fitness will be measured by oxygen consumption
5 secondary outcomes
MS Self-efficacy scale
Time frame: Baseline up to 6 months
Exercise adherence
Time frame: Baseline up to 6 months
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Baseline up to 6 months
Berg Balance Scale (BBS)
Time frame: Baseline up to 6 months
2-Minute Walk Test (2MWT)
Time frame: Baseline up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Stein, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home telerehabilitation in people with Multiple Sclerosis, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory fitness (time frame: Baseline up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021.