Ankle Robotics After Stroke

NCT04594837 | Unknown DMC

• 1 other identifier: 1 U44 111076-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (12)

• Active range of motion for Dorsiflexion

  Change from Baseline at both 9 Weeks and at 21 Weeks

• Ankle Muscle Strength

  Change from Baseline at both 9 Weeks and at 21 Weeks

• Number of Participants Using Assistive Devices and Ankle Foot Orthoses

  Change from Baseline at both 9 Weeks and at 21 Weeks

• Dynamic Gait Index

  Change from Baseline at both 9 Weeks and at 21 Weeks

• Berg Balance Scale

  Change from Baseline at both 9 Weeks and at 21 Weeks

Study Arms (4)

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

EXPERIMENTAL

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.

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

PT (Physical Therapy Only) (Phase II)

ACTIVE COMPARATOR

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.

Other: Physical Therapy Only (Phase II)

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

EXPERIMENTAL

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.

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

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

EXPERIMENTAL

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.

Device: Chronic Stroke Subjects to receive robotic gait training therapy.

Interventions

PTR Physical Therapy while wearing Robot group (Phase II) DEVICE

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.

Also known as: PTR

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

Physical Therapy Only (Phase II) OTHER

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.

Also known as: PT

PT (Physical Therapy Only) (Phase II)

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

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.

Also known as: X-PTR

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

Chronic Stroke Subjects to receive robotic gait training therapy. DEVICE

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.

Also known as: C-PTR

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NextStep Robotics Inc.: lead

Study Sites (1)

University of Maryland Rehabilitation & Orthopaedic Institute

Baltimore, Maryland, 21207, United States

RECRUITING

Related Publications (2)

• Roy A, Hennessie B, Hafer-Macko C, Forrester LW, Westlake K, Macko RF. Adaptive control ankle robotics training durably improves gait biomechanics in chronic hemiparetic stroke and footdrop. J Neuroeng Rehabil. 2025 Dec 29. doi: 10.1186/s12984-025-01834-2. Online ahead of print. No abstract available.

  PMID: 41462280 DERIVED

• Roy A, Hennessie B, Hafer-Macko C, Westlake K, Macko R. Dorsiflexion Specific Ankle Robotics to Enhance Motor Learning After Stroke: A Preliminary Report. Res Sq [Preprint]. 2024 Jun 25:rs.3.rs-4390770. doi: 10.21203/rs.3.rs-4390770/v1.

  PMID: 38978605 DERIVED

MeSH Terms

Conditions

Peroneal Neuropathies; Stroke; Paresis

Interventions

Clinical Trials, Phase II as Topic

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Trials as Topic; Clinical Studies as Topic; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Brad Hennessie, MHA, MBA

  NextStep Robotics Inc.

  STUDY DIRECTOR

Central Study Contacts

Josh Rudnicki

CONTACT

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

Richard Macko, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: August 20, 2020
• Primary Completion: February 28, 2025
• Study Completion: February 28, 2025
• Last Updated: January 26, 2023

Record last verified: 2023-01

Locations

US (1)