Assistive Device Training in Multiple Sclerosis

NCT02408718 | Completed

• 1 other identifier: 3559
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Mobility; walking aids; falls; gait and balance

Outcome Measures

Primary Outcomes (3)

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

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

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

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

  Change in rate of falls between time frames

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

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

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

  At baseline, 1 week after completion of training

Secondary Outcomes (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

• 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

• 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

Study Arms (2)

Training group

ACTIVE COMPARATOR

Subjects randomized to this group will receive a 6 week Assistive Device Training program in the use of their assistive device. They will have mobility assessments taken at baseline, after the training program has been completed, and 3 months later. During this time, their falls will be recorded monthly using prospective falls calendars. Members of this group will also receive MRI scans at baseline and after the completion of the training program.

Behavioral: Assistive Device Training

Wait-list control

NO INTERVENTION

Subjects in this group will participate in the same mobility assessments and completion of the falls calendars, but will receive no intervention during this time. These subjects will have the opportunity to receive the training sessions when all assessment visits have been completed. These subjects will not receive MRI scans.

Interventions

Assistive Device Training BEHAVIORAL

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

Training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Portland VA Medical Center: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

VA Portland Health Care System

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• Martini DN, Zeeboer E, Hildebrand A, Fling BW, Hugos CL, Cameron MH. ADSTEP: Preliminary Investigation of a Multicomponent Walking Aid Program in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2018 Oct;99(10):2050-2058. doi: 10.1016/j.apmr.2018.05.023. Epub 2018 Jun 26.

  PMID: 29958906 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michelle H. Cameron, MD, PT MCR

  Portland VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 3, 2015
• Study Start: July 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 21, 2016

Record last verified: 2016-04

Locations

US (1)