About the AMBLE Study

About the AMBLE Study

The AMBLE study is investigating the use of a portable ankle robot during physical therapy in individuals that have foot drop caused by stroke. This is the first randomized study (individuals who will wear the ankle robot will be decided by chance) to examine whether wearing a lightweight, battery-operated ankle robot over the shoe for 9 weeks during physical therapy is more effective than physical therapy without the ankle robot. This exercise device under the supervision of a physical therapist is aimed at assisting the foot during walking to reduce foot drop and improve walking safety. This device will only be worn at the clinic during physical therapy sessions and will not be taken home.

Up to 140 participants will be participating in the AMBLE study – some participants will be asked to undergo physical therapy using an ankle robot while other participants will be asked to undergo physical therapy without using the ankle robot. This will be determined entirely upon chance, similar to flipping a coin. Participants will have an equal chance of wearing, or not wearing, the portable ankle robot.

All participants who are eligible and successfully enroll in this study will be asked to participate in the study for up to 15 weeks, including screening periods. Those who are interested in enrolling will be asked to undergo medical history, review of medical records, physical and neurological evaluations during screening. The purpose of this is to see if individuals are safe and appropriate to participate.

Participants who have successfully enrolled will be asked to attend outpatient physical therapy for stroke rehabilitation consisting of about 9 weeks of 2 sessions per week (18 total sessions) lasting 45-60 minutes. Every session is under the supervision of a trained physical therapist or exercise specialist. The standard course of physical therapy will be the same whether the individual is in the regular physical therapy group or the group wearing the ankle robot during physical therapy.

Participants will be asked to undergo several tests at three different times: before physical therapy, after the 9 weeks of physical therapy, and 3 months after completion of physical therapy. Tests can include usual wellness exams, walking tests, balance tests, and treadmill tests.

If you’re interested in enrolling in a research study for foot drop from stroke, consider participating in the AMBLE study. You may be eligible to participate if you:

There are additional study requirements to participate. Upon study completion, time and travel will be compensated for eligible patients in the form of $10 per study visit. This is to be dispersed once study participation is completed.