TREAT Foot Drop After Stroke With Ankle Robot

Withdrawn before enrolling · Not applicable

Conditions studied: Foot Drop, Stroke, Hemiparesis

In brief

Researchers at the University of Maryland Rehabilitation and Orthopaedic Institute are looking for individuals who have suffered a stroke and have leg and ankle weakness (foot-drop), to participate in a pilot study to examine the safety and effectiveness of an ankle robot walking program on walking function This is the first in human test of walking training over-ground using a wearable, lightweight, battery operated ankle robot exoskeleton; with assistance by trained research personnel for safety. This exercise device is aimed at assisting the foot during walking to reduce foot drop and improve walking safety in chronic, mild to moderately impaired stroke survivors who have foot drop. Possible risks of participating in this study are described in this document. The greatest risks include the risk of falling, muscle soreness, skin irritation, or cardiovascular complications. Before starting, you will have a medical history and medical assessments performed to determine if this study is safe for you. All sessions will be assisted by trained research personnel under supervision of a physical therapist, with medical personnel locally on call.

Key facts

Study ID

NCT04137809

Run by

NextStep Robotics Inc.

People needed

0

Starts

2020-04-01

Expected to finish

2020-08-01

Last updated by the study team

2020-09-11

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 21-75 years
• Greater than 3 months post stroke
• Hemiparetic stroke with foot drop (Dorsiflexion deficit)
• Dorsiflexion deficit for active range of motion (unable to reach zero degrees)
• Dorsiflexion deficit for strength with a manual motor score between 1/5 and 4/5
• Mild-moderate severity hemiparetic gait, identified by reduced stance, or reduced stance plus increased swing on affected side
• Able to participate in physical therapy for mobility recovery, defined by capacity to walk 10-m over-ground, albeit with minimal assist (FIM Mobility Subscale 4; subject can perform 75% of the task), supervision (FIM Mobility Score 5) or modified independence (FIM Mobility Score 6; use an assistive device)
• Adequate language and cognitive function to participate in routine mobility physical therapy

You may not qualify if…

• Cardiac history of unstable angina, recent (<3 mos.) myocardial infarction, congestive heart failure, significant valvular dysfunction
• Hypertension contraindicating rehabilitation (>160/100, two assessments)
• Peripheral arterial occlusive disease (Fontaine II)
• Orthopedic/chronic pain conditions precluding robot use
• Pulmonary or renal failure or active cancer
• Non-stroke neuromuscular or neurological conditions that restrict gait or could confound interpretation of key outcomes
• Aphasia, unable to follow 2 step commands, or communicate pain, discomfort, or sufficiently interact with PT/staff to participate in PT or PTR treatment assignments, as per judgment of a credentialed clinician
• Cognitive dysfunction that confounds participation, including diagnosis of dementia including Alzheimer's Disease and Alzheimer's Related Disorders, or active delirium (as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM- 5));
• Modified Ashworth Spasticity >3 (considerable increase in muscle tone, passive movement difficult) or contractures that preclude adequate volitional range of motion (ROM) for motor learning
• Foot and lower leg pain or deformities that complicate safe and effective robot fit
• Active deep venous thrombosis
• Skin lesions, infections, other cutaneous or musculoskeletal conditions of the shank that would complicate robot attachment to the leg
• Untreated and active major depression

Where it is running

• UM Rehabilitation & Orthopaedic Institute — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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