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Portable Ankle Robotics to Reverse Foot Drop After Stroke

Status: Recruiting

Location: See location...

Intervention Type: Device, Other

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Maryland

University of Maryland Rehabilitation & Orthopaedic Institute

RECRUITING

Baltimore

Contact Information

Primary

Josh Rudnicki

JRudnicki@som.umaryland.edu

443-869-3518

Backup

Richard Macko, MD

Time Frame

Start Date: 2020-08-20

Estimated Completion Date: 2025-02-28

Participants

Target number of participants: 140

Treatments

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.

Related Therapeutic Areas

Stroke

Foot Drop

Mononeuritis Multiplex

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