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

Texas Woman's University

Status: Unknown

Conditions: Cognitive Impairment; Gait Disorders, Neurologic; Multiple Sclerosis

Treatments: Other: Single-task gait; Other: Dual-task gait

Study type: Interventional

Funder types: Other

Identifiers

NCT03536299

20068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Single-Task Gait

Active Comparator group

Description:

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

Treatment:

Other: Single-task gait

Dual-Task Gait

Experimental group

Description:

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

Treatment:

Other: Dual-task gait