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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Cognitive Impairment; Gait Disorders, Neurologic
• Intervention / Treatment: Other: Single-task gait; Other: Dual-task gait

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gregory A Brusola, PT,DPT,MSCS; Phone Number: 940-268-3482; Email: gregory.brusola@memorialhermann.org
• Study Contact Backup: Name: Katy Mitchell, PT, PhD; Phone Number: 713-794-2070; Email: kmitchell@twu.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Woman's University Institute of Health Sciences - Houston Center
      • Contact: Gregory A Brusola, PT,DPT,MSCS; Phone Number: 940-268-3482; Email: gregory.brusola@memorialhermann.org
    • Houston, Texas, United States, 77030
      • Recruiting
      • TIRR Memorial Hermann Adult and Pediatric Outpatient Rehabilitation at the Kirby Glen Center
      • Contact: Gregory A Brusola, PT,DPT,MSCS; Phone Number: 940-268-3482; Email: gregory.brusola@memorialhermann.org
      • Sub-Investigator: Marissa Lyon, PT, DPT
      • Sub-Investigator: Daniel Wingard, PT, DPT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 2-Minute Walk Test	Measures total distance walked by an individual within a 2-minute time period. Measures distance in feet and meters.	Week 1, Week 2, Week 5, Week 8, Week 12
Change in 12-Item Multiple Sclerosis Walking Scale	Measures self-reported and self-perceived walking disability due to MS in the past 2 weeks. The 12-Item Multiple Sclerosis Walking Scale consists of 12 questions. Each question is rated on a Likert scale from 1 (not at all) to 5 (extremely). The items are scored for a minimum score possible of 12 or a maximal score of 60. This summed score is then divided by 60 and the resulting percentage is interpreted. The scale's final percentage score can range from a minimum of 20% (minimal impact of MS on walking, good outcome) to a maximum of 100% (significant impact of MS on walking, poor outcome).	Week 1, Week 2, Week 5, Week 8, Week 12
Change in Fatigue Scale for Motor and Cognitive Functions	Measures self-reported physical and mental fatigue levels by the patient with MS. The Fatigue Scale for Motor and Cognitive Functions measures both the motor and cognitive domains of fatigue. The scale consists of 20 total items: 10 items related to motor fatigue and 10 items related to cognitive fatigue. Each item is rated on a Likert scale from 1 (does not apply at all) to 5 (applies completely). The scale items can be summed for a total score (ranging from 20 to 100) or subscales can be summed and interpreted with each subscale ranging from a minimum of 10 points to a maximal 50 points. Higher values in the total score or in the subscale scores indicate worse fatigue and poorer quality of life due to fatigue.	Week 1, Week 2, Week 5, Week 8, Week 12
Change in Gait Speed	Changes in gait speed (m/s) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.	Week 1, Week 2, Week 5, Week 8, Week 12
Change in Gait Cadence	Changes in gait cadence (steps/min) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.	Week 1, Week 2, Week 5, Week 8, Week 12
Change in Step Length	Changes in step length (cm) will be measured for a 10-meter distance. This will be measured by the Protokinetics ZenoWalkway.	Week 1, Week 2, Week 5, Week 8, Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Visual Analog Scale for Fatigue	The visual analog scale for fatigue measures immediate self-reported fatigue. This scale is commonly used to monitor and individual's fatigue level to ensure his or her safety during an activity. The individual marks his or her fatigue level on a 10-cm line with one end denoting "no fatigue" and the opposite end denoting "very severe fatigue". The individual's fatigue level is them measured in cm.	Week 1, Week 2, Week 5, Week 8, Week 12
Changes in Borg Rating of Perceived Exertion	The Borg Rating of Perceived Exertion is a self-reported scale that measures how much exertion an individual is putting forth during a physical activity. It ranges from 6 (no exertion) to 20 (maximal exertion). The individual chooses a number between 6 and 20 to represent his or her level of exertion. This is commonly used to monitor an individual to ensure that he or she is exercising or performing within a safe level.	Week 1, Week 2, Week 5, Week 8, Week 12

Collaborators and Investigators

• Sponsor: Texas Woman's University
• Collaborators: The University of Texas Health Science Center, Houston; TIRR Memorial Hermann
• Investigators: Principal Investigator: Gregory Brusola, PT,DPT,MSCS, Texas Woman's University & TIRR Memorial Hermann

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2018
• Primary Completion (ANTICIPATED): May 31, 2020
• Study Completion (ANTICIPATED): May 31, 2020

Study Registration Dates

• First Submitted: May 2, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (ACTUAL): May 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy; Gait training; Cognitive-motor interference
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Multiple Sclerosis; Sclerosis; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 20068 (Other Identifier: City of Hope Comprehensive Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No