Ankle Robotics After Stroke

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
NextStep Robotics Inc.
Study ID
NCT04594837
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.
  • 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.
  • 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.

Study Details

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).

Key Dates

Start date
Aug 20, 2020
Status verified
Jan 2023
Primary completion
Feb 28, 2025
Completion
Feb 28, 2025

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Angle at Initial Contact [ Time Frame: Change from Baseline at both 9 Weeks and at 21 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Rehabilitation & Orthopaedic InstituteBaltimoreMaryland21207
Josh Rudnicki
[email protected]
443-869-3518

Find similar trials in Baltimore, MD

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
University of Maryland Rehabilitation & Orthopaedic Institute· Baltimore, MD

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