Measurement and Training of Dual-Task of Gait in Persons With Multiple Sclerosis

NCT ID: NCT03536299

Last Updated: 2019-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-31

Study Completion Date

2020-05-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Gait Disorders, Neurologic Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Single-Task Gait

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

Group Type ACTIVE_COMPARATOR

Single-task gait

Intervention Type OTHER

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.

Dual-Task Gait

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

Group Type EXPERIMENTAL

Dual-task gait

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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TIRR Memorial Hermann

OTHER

Sponsor Role collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role collaborator

Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Brusola, PT,DPT,MSCS

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University & TIRR Memorial Hermann

Locations

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

Houston, Texas, United States

Site Status RECRUITING

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

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Gregory A Brusola, PT,DPT,MSCS

Role: CONTACT

940-268-3482

Katy Mitchell, PT, PhD

Role: CONTACT

713-794-2070

Facility Contacts

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Gregory A Brusola, PT,DPT,MSCS

Role: primary

940-268-3482

Gregory A Brusola, PT,DPT,MSCS

Role: primary

940-268-3482

Other Identifiers

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20068

Identifier Type: -

Identifier Source: org_study_id

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