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Completed

NCT Number: NCT02408718

Assistive Device Training in Multiple Sclerosis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Portland Health Care System

Portland, Oregon, 97239, United States

About this study

40 people with Multiple Sclerosis, who routinely use ambulatory assistive devices and have fallen at least once in the past year, will be randomized into two groups. One group will receive a 6-week training program in the use of their assistive device; the other group will be wait-listed, and may choose to receive the training after their participation in the study is completed. All participants will receive mobility assessments at baseline, 6-8 weeks later, and 3 months after that. All participants will record their falls on falls calendars. Participants in the training group will receive MRI scans to assess neural connectivity at baseline and after completion of the training program.

The purpose of the study is to determine whether participation in the training program reduces falls and increases functional mobility when compared to the wait-listed group, and also to determine whether any change in neural connectivity, as assessed by MRI scans, is seen in those who participate in the training.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Assistive Device Training

Behavioral

Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).

Primary outcomes

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

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

    Timed Up and Go test, Timed 25-Foot Walk, 2 minute timed walk), Multiple Sclerosis Walking Scale-12

  2. Change from Baseline in Falls at Completion of Training and the Following Three Months

    Time frame: First week of training, last week of training, 3 months later

    Change in rate of falls between time frames

  3. Change from Baseline in Functional Neural Connectivity (fMRI) at Completion of Training

    Time frame: At baseline, 1 week after completion of training

    Resting-state (task free) functional Magnetic Resonance Imaging (fcMRI)

Secondary outcomes

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

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

    Quebec User Evaluation of Satisfaction with Assistive Technologies

  2. Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months

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

    Activities-specific Balance Confidence Questionnaire

  3. Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months

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

    Multiple Sclerosis Impact Scale-29

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

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

    International Physical Activity Questionnaire

Sponsors and collaborators

Lead sponsor

Portland VA Medical Center

Fed

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis

Acronym: ADT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2015
Registry last updated
Sep 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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