Assistive Device Training in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— ADT  

Official title:

Assistive Device Training for Functional Mobility and Connectivity in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408718
• Other study ID #: 3559
• Status: Completed
• Phase: N/A
• First received: March 27, 2015
• Last updated: September 20, 2016
• Start date: July 2015
• Est. completion date: September 2016

Study information

• Verified date: April 2016
• Source: Portland VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Assistive Device Training
Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).

Locations

Country	Name	City	State
United States	VA Portland Health Care System	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Portland VA Medical Center	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	Change from Baseline in Satisfaction with Assistive Device at Completion of Training and the Following Three Months	Quebec User Evaluation of Satisfaction with Assistive Technologies	At baseline, 1 week after completion of training, 3 months later	No
Secondary	Change from Baseline in Balance Confidence at Completion of Training and the Following Three Months	Activities-specific Balance Confidence Questionnaire	At baseline, 1 week after completion of training, 3 months later	No
Secondary	Change from Baseline in Multiple Sclerosis Impact at Completion of Training and the Following Three Months	Multiple Sclerosis Impact Scale-29	At baseline, 1 week after completion of training, 3 months later	No
Secondary	Change from Baseline in Physical Activity at Completion of Training and the Following Three Months	International Physical Activity Questionnaire	At baseline, 1 week after completion of training, 3 months later	No