Stroke Clinical Trial
Official title:
Portable Ankle Robotics to Reverse Foot Drop After Stroke
The randomized study (in Phase II of the U44) compares the efficacy and durability of 9 weeks (18 sessions) of robot-assisted physical therapy (PTR) versus physical therapy (PT) alone on foot drop as assessed by gait biomechanics (ankle angle at initial contact, peak swing ankle angle, number of heel-first strikes - % total steps, gait velocity) and blinded clinician assessment (dorsiflexion active range of motion, ankle muscle strength, assistive device needs).
Status | Recruiting |
Enrollment | 140 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Ages 18 and older - In the subacute phase of stroke recovery (>6 weeks to <6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop. - or - In the chronic phase of stroke recovery (>6 months post-stroke) with residual hemiparesis of the lower extremity that includes symptoms of foot-drop. - Clear indications of hemiparetic gait by clinical observation Exclusion Criteria: - 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 - Hypertension that is a contraindication for routine physical therapy (greater than 160/100 on two assessments). - 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 - History of non-stroke neuromuscular disorder restricting gait. - Aphasia or cognitive functioning that confounds participation, defined as unable to follow 2 step commands or judgment of the medical officer or therapist. |
Country | Name | City | State |
---|---|---|---|
United States | University of Maryland Rehabilitation & Orthopaedic Institute | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
NextStep Robotics Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Angle at Initial Contact | Angle at initial contact averaged across each gait cycle for each subject at a given testing time point. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Primary | Swing Dorsiflexion | Peak swing dorsiflexion averaged across each gait cycle for each subject at a given testing time point. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Primary | Number of Heel-First Foot Strikes | Number of heel-first foot strikes for each subject at a given testing time point. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Primary | Gait Velocity | Average gait velocity (meters/second) for each subject at a given testing time point. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Active range of motion for Dorsiflexion | Active range of motion measured for dorsiflexion by blinded clinician. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Ankle Muscle Strength | Measurement of ankle strength by blinded clinician using the MMT (manual muscle testing) | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Number of Participants Using Assistive Devices and Ankle Foot Orthoses | Number of Participants Using Assistive Devices and Ankle Foot Orthoses | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Dynamic Gait Index | Assesses gait, balance, and fall risk; ranges from 0-24; higher score is better | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Berg Balance Scale | A 14-item objective measure designed to assess static balance and fall risk; ranges from 0-56; higher score is better | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Stroke Impact Scale | A self-report questionnaire that evaluates disability and health-related quality of life after stroke. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Activities-Specific Balance Confidence Scale | A self-report measure of balance confidence in performing various activities without losing balance; ranges from 0-1600; higher score is better | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | CES-D (Center for Epidemiological Studies-Depression) | The Center of Epidemiological Studies-Depression, a 20-item measure that asks to rate how often over the past week the patient experienced symptoms associated with depression; ranges from 0-60; high scores indicating greater depressive symptoms. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | NIH Stroke Scale | Tool used to quantify the impairment caused by a stroke, composed of 11 items; ranges from 0-42; higher score indicates greater impairment. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Falls Efficacy Scale | A 16-item self-administered questionnaire designed to assess fear of falling; ranges 16-64; higher score indicates greater fear of falling. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Fatigue Assessment Scale | 10-item scale evaluating symptoms of fatigue; ranges from 10-50; higher score indicates greater levels of fatigue. | Change from Baseline at both 9 Weeks and at 21 Weeks | |
Secondary | Modified Ashworth Scale | Measures spasticity in patients; ranges from 0-4; higher score indicates more spasticity/rigidity. | Change from Baseline at both 9 Weeks and at 21 Weeks |
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