Physical Telerehabilitation in Veterans With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT02346734

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
The Berg Balance Scale (BBS)Mean Difference (Final Values) -13.9<0.05

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Multiple Sclerosis Home Automated Telemanagement (MS HAT) system

Results by group

The Berg Balance Scale (BBS)

6 month evaluation

GroupValueIntervalNumber analysed
Control50 score on a scale9.9 (Standard Deviation)8
MSHAT36.1 score on a scale18.9 (Standard Deviation)16

Control

50

MSHAT

36.1

p = <0.05; Mean Difference (Final Values) -13.9

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
MSHAT260 (0.0%)0
Control250 (0.0%)0

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

  • The Berg Balance Scale (BBS)

    6 month evaluation

    Walking and mobility

Other measures (4)

  • Patient Determined Disease Steps (PDDS)

    6-month evaluation

    Quality of life (reported by participants)
  • The Timed 25-Foot Walk (T25-FW)

    6-month Evaluation

    Disability progressionWalking and mobility
  • Multiple Sclerosis Walking Scale (MSWS-12)

    6-month evaluation

    Walking and mobility
  • The Six Minute Walk Test (6MWT)

    6-month evaluation

    Walking and mobilityPhysical function

Who could take part

MS (type not specified) · 18 to 65

Show the full criteria

Inclusion criteria

* Age: 18-65 * Clinical Diagnosis of MS based on McDonald criteria * Functional disability defined by the PDDS in the range of 2 to 6 * Have a working telephone line in their home or a cell phone * Willingness and ability to use MS HAT platform with individual modifications based on preferred user interface * Patient demonstrates ability to successfully perform physical therapy exercises and procedures independently or with assistance of a caregiver. * Ability to complete 25-foot walk test in at least 3 minutes

Exclusion criteria

* Age less than 18 years old * No diagnosis of MS * Other musculoskeletal diagnoses, unstable cardiovascular, respiratory, metabolic or other conditions that would interfere with this study * One or more exacerbations in the preceding 3 months * Received a course of steroids (IV or oral) within 60 days of screening

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The primary objective of this study will be to assess the feasibility and patient acceptance of a Home Automated Telemanagement (HAT) system in multiple sclerosis patients. Our hypothesis is that home telemanagement will be effective and useful in the rehabilitation of multiple sclerosis patients. Specifically, the investigators hypothesize that home telemanagement using a daily exercise diary, monitoring of compliance with a tailored exercise program and regular assessment of strength and motor functions will: 1. Be feasible and acceptable in patients with multiple sclerosis 2. Improve patient compliance with home exercise program 3. Increase patient mobility and motor functions 4. Be a feasible and effective mechanism for affecting multiple sclerosis patient self-efficacy 5. Improve quality of life

Papers

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History

    1. Started

      Jul 2012

    2. Main results due

      Apr 2017

    3. Finished

      Apr 2017

    4. Results posted

      May 2026

    Assembled by software from public sources.