About the AMBLE Study

frequently asked questions

To participate in this study, you or a loved one:

  • Are 18 years old or older
  • Had a stroke at least 6 weeks ago
  • Are struggling with foot drop (ankle weakness, difficulty lifting the upper part of the foot)

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.

There will be additional criteria that are reviewed by the study team during your first appointment.

A more extensive list of criteria can be found below:

Inclusion Criteria

  1. In the chronic phase of stroke recovery ( at least6 months post-stroke)
  2. Clear indications of hemiparetic gait by clinical observation
  3. Manual muscle score for ankle DF on affected site is rated 1/5 (trace) to 4/5 (reduced strength)
  4. Patient able to complete 3 meter walk independently (with or without assistive device)
  5. Patient aged 18 years or older

Exclusion Criteria

  1.  Cardiac history of (a) unstable angina, (b) recent (less than 3 months) myocardial infarction, congestive heart
    failure (NYHA category II); (c) hemodynamically significant valvular dysfunction
  2. Hypertension that is contraindication for routine physical therapy (greater than 160/100 on two assessments)
  3. Medical History: (a) recent hospitalization (less than 3 months) for severe medical disease, (b) symptomatic
    peripheral arterial occlusive disease, (c) orthopedic or chronic pain conditions that significantly alter gait function,
    (d) pulmonary or renal failure, (e) active cancer
  4. History of non-stroke neuromuscular disorder restricting gait
  5. Aphasia or cognitive functioning that confounds participation, defines as unable to follow 2 step commands or
    judgement of medical officer or therapist

You will meet with a study coordinator at a study site location closest to you. You will learn more about the research study and the benefits and risks of participation.

The study coordinator or study doctor will review the Informed Consent Form with you. You will have the chance to ask any questions about this form, and sign once comfortable and willing to participate in the study. Different procedures will be performed to see if you qualify for the clinical study.

The study device being investigated is a lightweight, battery-operated portable ankle robot. The portable ankle robot is to be worn over the shoe and is meant to be worn during physical therapy sessions. The robot will be fitted and secured to the foot drop affected lower leg using a shin guard and Velcro straps. This device will only be worn at the clinic during physical therapy sessions and will not be taken home.

All participants who are eligible and successfully enroll in this study will be asked to participate in the study for a 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 physical therapist. 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.

The study centers are located in Baltimore, MD.

You do not have to stop taking your medication unless you are advised to do so by the study center staff or your primary care physician.

No, there will be no cost to you for the study therapy or study procedures.

No, health insurance is not a requirement to participate in either study.

Clinical Research Studies

Clinical trials, also known as clinical studies or research studies are conducted by doctors and researchers to see if new medications or treatments are safe and effective before being approved for use by the general public. Participation in a clinical trial is completely confidential and will be protected just like any other medical information.

Research studies are used to test new medications for safety, tolerability, and effectiveness before they are approved for use by the public.

You can find out more information about clinical trials by browsing through www.clinicaltrials.gov. his is an online, government database that is managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research studies.

All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits and activities of a research study. Interested participants will sign an Informed Consent Form prior to enrolling in the study. This form shows that a participant understands what will happen during the study and that they can leave the study at any time.