Recruiting

Observational Study

Sponsor:

Texas Woman's University

Code:

NCT03536299

Conditions

Multiple Sclerosis

Gait Disorders, Neurologic

Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Dual-task gait

Single-task gait

Study Details

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.

Conditions

Multiple Sclerosis

Gait Disorders, Neurologic

Cognitive Impairment

Study ID

NCT03536299

Start date

May 31, 2018

Status verified date

Sep, 2019

Completion date

May 31, 2020

Anticipated

Primary completion date

May 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Single-Task Gait

The Single-Task Gait group will be provided with gait training without the Dual-Task cognitive tasks.

experimental: Dual-Task Gait

The Dual-Task Gait group will be provided with gait training AND secondary cognitive tasks during gait training.

Interventions

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.

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.

Primary outcome measure

  • Change in Walking and Remembering Test [ Time Frame: Week 1, Week 2, Week 5, Week 8, Week 12 ]

Central Contacts and Locations

Central contacts

Gregory A Brusola, PT,DPT,MSCS

940-268-3482gregory.brusola@memorialhermann.org

Katy Mitchell, PT, PhD

713-794-2070kmitchell@twu.edu

Locations

Texas Woman's University Institute of Health Sciences - Houston Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Gregory A Brusola, PT,DPT,MSCS

940-268-3482gregory.brusola@memorialhermann.org

TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Gregory A Brusola, PT,DPT,MSCS

940-268-3482gregory.brusola@memorialhermann.org

More Information

Sponsor

Texas Woman's University

Last update posted

Sep 18, 2019

Last verified

Sep, 2019

Keywords

  • Physical therapy
  • Gait training
  • Cognitive-motor interference
  • Rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Texas Woman's University on 2019-09-18.