Recruiting

Ankle Robotics

Sponsor:

NextStep Robotics Inc.

Code:

NCT04594837

Conditions

Foot Drop

Stroke

Hemiparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PTR Physical Therapy while wearing Robot group (Phase II)

Physical Therapy Only (Phase II)

Cross over group for Physical Therapy n Sub-Acute group. (Phase II)

Chronic Stroke Subjects to receive robotic gait training therapy.

Study Details

Brief summary:

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).

Conditions

Foot Drop

Stroke

Hemiparesis

Study ID

NCT04594837

Start date

Aug 20, 2020

Status verified date

Jan, 2023

Completion date

Feb 28, 2025

Anticipated

Primary completion date

Feb 28, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: PTR (Physical Therapy while wearing Robot group) (Phase II)

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.

active comparator: PT (Physical Therapy Only) (Phase II)

Subjects 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.

experimental: X-PTR, Cross over group for Physical Therapy n Sub-Acute group.

Participants 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.

experimental: C-PTR, Chronic Stroke Subjects to receive robotic gait training therapy.

Chronic 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.

Interventions

PTR Physical Therapy while wearing Robot group (Phase II)

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.

Physical Therapy Only (Phase II)

Subjects 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)

Participants 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.

Chronic 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.

Primary outcome measure

  • Angle at Initial Contact [ Time Frame: Change from Baseline at both 9 Weeks and at 21 Weeks ]
  • Swing Dorsiflexion [ Time Frame: Change from Baseline at both 9 Weeks and at 21 Weeks ]
  • Number of Heel-First Foot Strikes [ Time Frame: Change from Baseline at both 9 Weeks and at 21 Weeks ]
  • Gait Velocity [ Time Frame: Change from Baseline at both 9 Weeks and at 21 Weeks ]

Central Contacts and Locations

Central contacts

Josh Rudnicki

443-869-3518JRudnicki@som.umaryland.edu

Locations

University of Maryland Rehabilitation & Orthopaedic Institute

Recruiting

Baltimore, Maryland, United States, 21207

Contacts

Josh Rudnicki

443-869-3518JRudnicki@som.umaryland.edu

More Information

Sponsor

NextStep Robotics Inc.

Last update posted

Jan 26, 2023

Last verified

Jan, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NextStep Robotics Inc. on 2023-01-26.