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

NCT03536299 | Unknown

• 1 other identifier: 20068
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Walking and Remembering Test

  Measures dual-task cost of gait and a titrated forward digit span cognitive task, measured as a percentage.

  Week 1, Week 2, Week 5, Week 8, Week 12

Secondary Outcomes (6)

• Change in 2-Minute Walk Test

  Week 1, Week 2, Week 5, Week 8, Week 12

• Change in 12-Item Multiple Sclerosis Walking Scale

  Week 1, Week 2, Week 5, Week 8, Week 12

• Change in Fatigue Scale for Motor and Cognitive Functions

  Week 1, Week 2, Week 5, Week 8, Week 12

• Change in Gait Speed

  Week 1, Week 2, Week 5, Week 8, Week 12

• Change in Gait Cadence

  Week 1, Week 2, Week 5, Week 8, Week 12

Other Outcomes (2)

• Changes in Visual Analog Scale for Fatigue

  Week 1, Week 2, Week 5, Week 8, Week 12

• Changes in Borg Rating of Perceived Exertion

  Week 1, Week 2, Week 5, Week 8, Week 12

Study Arms (2)

Single-Task Gait

ACTIVE COMPARATOR

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

Other: Single-task gait

Dual-Task Gait

EXPERIMENTAL

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

Other: Dual-task gait

Interventions

Dual-task gait 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.

Dual-Task Gait

Single-task gait 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.

Single-Task Gait

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Texas Woman's University: lead
• TIRR Memorial Hermann: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (2)

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

Houston, Texas, 77030, United States

RECRUITING

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

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis; Gait Disorders, Neurologic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gregory Brusola, PT,DPT,MSCS

  Texas Woman's University & TIRR Memorial Hermann

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory A Brusola, PT,DPT,MSCS

CONTACT

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

Katy Mitchell, PT, PhD

CONTACT

713-794-2070; kmitchell@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2018
• First Posted: May 24, 2018
• Study Start: May 31, 2018
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)