Clinical trial NCT03536299: Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
Official title: Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Gait Disorders, Neurologic
Cognitive Impairment
Keywords: Physical therapy
Gait training
Cognitive-motor interference
Rehabilitation
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: TIRR Memorial Hermann
name: The University of Texas Health Science Center, Houston
First posted: 2018-05-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the utility of a performance measure for the dual-task of gait and considering people with multiple sclerosis have both cognitive and motor problems, the secondary aim of this study is to determine the effectiveness of a gait-specific dual-tasking intervention for ambulatory individuals with multiple sclerosis.

Detailed description: A total target sample size of 40 adults with MS and 40 adults without MS will be recruited. The 40 adults without MS will undergo the two baseline testing sessions only for the first phase of the study. 20 of those individuals with MS will be randomly selected to undergo the intervention phase of the study.

The research design will include two groups, the intervention and control group. Both groups will undergo a screening process, two baseline testing sessions, and be randomly assigned to one of the two groups. The duration of the study is 6 weeks in length for a total of 18 training sessions. The intervention group participants will undergo gait training with a specific concomitant cognitive task (dual-task) for a total walking time of 20 minutes and with rest breaks the total session time is \~60 minutes with a physical therapist. The control group will undergo gait training, but without the cognitive task. Feedback from the therapist will be provided to each participant concerning gait mechanics and ways to improve gait regardless of group membership.

Outcome measures data will be collected twice at baseline, once at mid-intervention, once at post-intervention, and once at one-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Ability walk independently with or without an assistive device
* Independent and community-dwelling
* No history or presence of other clinically significant musculoskeletal, cardiovascular, respiratory, or neurologic disease.
* Definite diagnosis of MS \[Expanded Disability Status Scale (EDSS) ≤6.5\]
* Relapse free for the past 30 days and not currently receiving or will receive any rehabilitation services during the study.

Exclusion Criteria:

- Participants experiencing a true relapse or exacerbation of their symptoms (\>24 hours duration in the absence infection or fever, or and ambient increase in body temperature) during the study will be excluded from the study.

Primary outcomes:
measure: Change in Walking and Remembering Test
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
Secondary outcomes:
measure: Change in 2-Minute Walk Test
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
measure: Change in 12-Item Multiple Sclerosis Walking Scale
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
measure: Change in Fatigue Scale for Motor and Cognitive Functions
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
measure: Change in Gait Speed
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
measure: Change in Gait Cadence
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
measure: Change in Step Length
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
Other outcomes:
measure: Changes in Visual Analog Scale for Fatigue
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
measure: Changes in Borg Rating of Perceived Exertion
timeFrame: Week 1, Week 2, Week 5, Week 8, Week 12
Locations:
city: Houston
country: United States
facility: Texas Woman's University Institute of Health Sciences - Houston Center
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center
state: Texas
Study officials:
affiliation: Texas Woman's University & TIRR Memorial Hermann
name: Gregory Brusola, PT,DPT,MSCS
role: PRINCIPAL_INVESTIGATOR
References: