RecruitingNot ApplicableNCT04594837

Ankle Robotics After Stroke

Portable Ankle Robotics to Reverse Foot Drop After Stroke

Sponsor

NextStep Robotics Inc.

Enrollment

140 participants

Start Date

Aug 20, 2020

Study Type

INTERVENTIONAL

Conditions

Hemiparesis Foot drop Stroke

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).

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Chronic Stroke Subjects to receive robotic gait training therapy., a medical device called Cross over group for Physical Therapy n Sub-Acute group. (Phase II), and others for people with foot drop, hemiparesis, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPTR 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.

OTHERPhysical 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.

DEVICECross 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.

DEVICEChronic 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.