Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT02408718

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What was tested

Treatment tested

  • Assistive Device Training

What it measured

Main measures

  • Change from Baseline in Functional Mobility at Completion of Training and the Following Three Months

    At baseline, 1 week after completion of training, 3 months later

    Disability progressionWalking and mobility
  • Change from Baseline in Falls at Completion of Training and the Following Three Months

    First week of training, last week of training, 3 months later

    Walking and mobility
  • Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training

    At baseline, 1 week after completion of training

    MRI lesionsNerve conduction tests

Other measures (4)

  • Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months

    At baseline, 1 week after completion of training, 3 months later

    Quality of life (reported by participants)
  • Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months

    At baseline, 1 week after completion of training, 3 months later

    Walking and mobility
  • Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months

    At baseline, 1 week after completion of training, 3 months later

  • Change from Baseline in Physical Activity at Completion of Training and the Following Three Months

    At baseline, 1 week after completion of training, 3 months later

    Physical function

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Multiple Sclerosis of any type, * self-reported history of at least 1 fall in the previous year, * able to walk at least 25 feet with or without an assistive device, * clinically stable Multiple Sclerosis (no relapse in 30 days prior to enrollment), * intermittent or constant unilateral or bilateral assistance required to walk, * right-handed, willingness to remain consistent with medication use and level of physical activity for the duration of the study.

Exclusion criteria

* serious psychiatric or medical conditions that would preclude reliable participation in the study, * dementia (MMSE \<24), * deafness, * blindness, * inability to follow directions in English, * significant upper extremity tremor or weakness, * more than 1 hour of assistive device training within the previous 3 years, * any exclusions to receiving MRI scans (implanted devices, anxiety, claustrophobia, body weight over 350 lbs).

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

About this trial

In the sponsor's words

The purpose of this study is to determine whether a training program in the use of ambulatory assistive devices (such as canes, walkers, etc) can reduce falls and increase functional mobility and neural connectivity in people with Multiple Sclerosis.

Papers

Loading reviews and guidelines…

History

    1. Started

      Jul 2015

    2. Main results due

      Sept 2016

    3. Finished

      Sept 2016

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