Print

Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Single-Task Gait 		The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks.
  • Other: Single-task gait
    During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. At the end of each session, you will have walked for a total walking time of 20 minutes.
Experimental
Dual-Task Gait 		The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training.
  • Other: Dual-task gait
    During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. In addition to performing the gait training activities, you will be asked to perform thinking tasks at the same time. These pre-recorded questions or prompts will be provided to you through headphones and a portable music player. This is to help ensure that the PT is able to focus on giving you feedback about your walking ability and answers to the thinking tasks, and on your safety. At the end of each session, you will have walked for a total walking time of 20 minutes.

Recruiting Locations

TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center
Houston, Texas 77030
Contact:
Gregory A Brusola, PT,DPT,MSCS
940-268-3482
gregory.brusola@memorialhermann.org

Texas Woman's University Institute of Health Sciences - Houston Center
Houston, Texas 77030
Contact:
Gregory A Brusola, PT,DPT,MSCS
940-268-3482
gregory.brusola@memorialhermann.org

More Details

Status
Unknown status
Sponsor
Texas Woman's University

Study Contact

Gregory A Brusola, PT,DPT,MSCS
940-268-3482
gregory.brusola@memorialhermann.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.