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Ankle Robotics After Stroke

StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated January 26, 2023 (before its estimated February 28, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Start date: Apr 21, 2022 to Aug 20, 2020
    • Interventions: PTR Physical Therapy while wearing Robot group (Phase II) (Device), Physical Therapy Only (Phase II) (Other), Unpowered Physical Therapy… to Chronic Stroke Subjects to receive robotic gait training therapy. (Device), Cross over group for Physical Therapy n Sub-Acute group. (Phase…
    • Eligibility criteria expanded, about 25 words
    • Study arms: 3 to 4
    v10
  2. Primary completion date: Apr 30, 2024 to Feb 28, 2025
    • Study completion date: Dec 31, 2024 to Feb 28, 2025
    v9
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2022 to Apr 21, 2022
    v8
  4. Start date: Oct 1, 2021 to Apr 1, 2022v7
  5. Start date: Jun 1, 2021 to Oct 1, 2021v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: May 1, 2021 to Jun 1, 2021v5
  2. Primary completion date: May 2023 to Apr 30, 2024
    • Study completion date: Dec 2023 to Dec 31, 2024
    • Start date: Apr 2021 to May 1, 2021
    v4
  3. Start date: Jan 2021 to Apr 2021v3
  4. Secondary endpoints revised (12)
    • Study description expanded, about 5 words
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04594837
Lead Sponsor NextStep Robotics Inc.
Conditions
(from sponsor)		 Foot Drop, Stroke, Hemiparesis
Related terms Paresis, Peroneal Neuropathies, Stroke
Enrollment 140 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov