Status:
WITHDRAWN
TREAT Foot Drop After Stroke With Ankle Robot
Lead Sponsor:
NextStep Robotics Inc.
Collaborating Sponsors:
University of Maryland, Baltimore
Conditions:
Foot Drop
Stroke
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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...
Detailed Description
This study is designed to see if the ankle robot is safe and effective to use in restoring gait function in individuals with foot drop. This research project will be conducted at the University of Ma...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04137809
Start Date
April 1 2020
End Date
August 1 2020
Last Update
September 11 2020
Active Locations (1)
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1
UM Rehabilitation & Orthopaedic Institute
Baltimore, Maryland, United States, 21207