Post-Stroke Walking Speed and Community Ambulation Conversion Study

Chronic Stroke Clinical Trial

Official title: Post-Stroke Walking Speed and Community Ambulation Conversion, A Pivotal Study

Status Completed

Clinical Trial Summary

The purpose of this randomized, controlled study is to collect performance data on the ability of an investigational device designed to digitally deliver Rhythmic Auditory Stimulation to improve walking speed in people who suffered a stroke greater than six (6) months in the past and who are limited in mobility outside the home. The primary outcomes will be the mean change in walking speed (meters per second) and mean percent change in walking speed as determined by a 10-meter Walk Test after five weeks of intervention and compared between groups.

Clinical Trial Description

Study participants who take part in this research study will participate in a screening visit, fifteen (15) intervention visits over approximately five weeks and a final closing visit. Study participants will be assigned by chance to one of the two study groups. Participants will not be able to switch groups once they are assigned. The investigational device includes a mobile device app and sensors that are attached to shoes. Headphones and a mobile device are also required to be used and will be provided in this study. ;

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

• NCT number: NCT04121754
• Study type: Interventional
• Source: MedRhythms, Inc.
• Status: Completed
• Phase: N/A
• Start date: September 17, 2019
• Completion date: February 11, 2022