Ankle Exosuit Training in the Clinic to Community Community
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04251091|
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : September 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Treadmill walking Other: Overground Walking||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Previous work has demonstrated that the tuning of the exosuit technology is important for each patient post stroke to be able to maximally utilize the technology. These modulations include when the plantarflexion force is delivered, and how to deliver the assistance within a training session however it is still unclear how to implement this into a training protocol. During a part of this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out a training protocol|
|Masking:||None (Open Label)|
|Official Title:||Ankle Exosuit Training in the Clinic to Community|
|Actual Study Start Date :||January 10, 2020|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||June 30, 2021|
Experimental: ReWalk Soft Exosuit
During this study, we will explore which timing: early timing (10-20%), mid timing (50%) and late timing (90%) may be optimal for an individual and then carry out an 18 session training protocol.
Other: Treadmill walking
Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets
Other: Overground Walking
Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets
- Change in 10 Meter Walk Test from baseline gait speed [ Time Frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12 ]This test will examine the patient's gait speed. Patients will be directed to walk at their preferred and maximum but safe speed. Patients will be positioned 1 meter before the start line and instructed to walk the entire distance and past the end line approximately 1 meter. The distance before and after the course are meant to minimize the effect of acceleration and deceleration. Time will be recorded using a stopwatch and recorded to the one hundredth of a second (ex: 2.15 sec).
- Change in 6 Minute Walk Test in distance from baseline [ Time Frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12 ]The 6 Minute Walk Test (6MWT) measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at study completion. The walk test is patient self-paced and assesses the level of functional capacity. Patients are allowed to stop and rest during the test, however, the timer does not stop. If the patient is unable to complete the time, the time stopped is noted and reason for stopping prematurely is recorded.
- Functional Gait Assessment (FGA) [ Time Frame: Baseline Day 1-3, Midpoint at week 6, Post-intervention at week 12 ]The Functional Gait Assessment is a 10 item test used to assess postural stability during walking tasks. It has a maximum score of 30 with each item being scored 0-3. It may be performed with or without an assistive device; however, individuals lose a point on all items requiring a device.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251091
|Contact: Kristen E Hohl, PT, DPTemail@example.com|
|Contact: Lori L McGee, OT, PhDfirstname.lastname@example.org|
|Principal Investigator:||Arun Jayaraman, PT, PhD||Shirley Ryan AbilityLab|