Ankle Robotics After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNextStep Robotics Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
PTR Physical Therapy while wearing Robot group (Phase II)
DeviceSubjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Physical Therapy Only (Phase II)
Other interventionSubjects receive 18 one-hour PT training sessions over 9 weeks. Subjects perform over-ground mobility tasks of increasing challenge with therapist assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Cross over group for Physical Therapy n Sub-Acute group. (Phase II)
DeviceParticipants enrolled in the physical therapy only group will be given the option to re-enroll as a cross over participant to receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Chronic Stroke Subjects to receive robotic gait training therapy.
DeviceChronic stroke subjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
Treatment groups
140 Participants
are divided into 4 treatment groupsGroup A: PTR (Physical Therapy while wearing Robot group) (Phase II)Experimental treatment 1 intervention
Group B: PT (Physical Therapy Only) (Phase II)Active comparator 1 intervention
Group C: X-PTR, Cross over group for Physical Therapy n Sub-Acute group.Experimental treatment 1 intervention
Group D: C-PTR, Chronic Stroke Subjects to receive robotic gait training therapy.Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Angle at Initial Contact
Angle at initial contact averaged across each gait cycle for each subject at a given testing time point.
Time frame
Change from Baseline at both 9 Weeks and at 21 Weeks2
Swing Dorsiflexion
Peak swing dorsiflexion averaged across each gait cycle for each subject at a given testing time point.
Time frame
Change from Baseline at both 9 Weeks and at 21 Weeks3
Number of Heel-First Foot Strikes
Number of heel-first foot strikes for each subject at a given testing time point.
Time frame
Change from Baseline at both 9 Weeks and at 21 Weeks4
Gait Velocity
Average gait velocity (meters/second) for each subject at a given testing time point.
Time frame
Change from Baseline at both 9 Weeks and at 21 WeeksSecondary outcomes
1
Active range of motion for Dorsiflexion
Active range of motion measured for dorsiflexion by blinded clinician.
Time frame
Change from Baseline at both 9 Weeks and at 21 Weeks2
Ankle Muscle Strength
Measurement of ankle strength by blinded clinician using the MMT (manual muscle testing)
Time frame
Change from Baseline at both 9 Weeks and at 21 Weeks3
Number of Participants Using Assistive Devices and Ankle Foot Orthoses
Number of Participants Using Assistive Devices and Ankle Foot Orthoses
Time frame
Change from Baseline at both 9 Weeks and at 21 Weeks4
Dynamic Gait Index
Assesses gait, balance, and fall risk; ranges from 0-24; higher score is better
Time frame
Change from Baseline at both 9 Weeks and at 21 WeeksSponsors and contacts
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Source ClinicalTrials.gov