NCT03536299

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Texas Woman's University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Multiple Sclerosis
• Gait Disorders, Neurologic
• Cognitive Impairment

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2018-05-31
• Primary completion: 2020-05-31
• Completion: 2020-05-31
• First posted: 2018-05-24
• Last updated: 2019-09-18

Locations

2 sites across 1 country: United States