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NCT04594837

Ankle Robotics After Stroke

Status unknown NA Last updated 26 January 2023
What this trial tests

NA trial testing PTR Physical Therapy while wearing Robot group (Phase II) in Foot Drop in 140 participants. Status unknown.

Timeline
20 August 2020
Primary endpoint
28 February 2025
28 February 2025

Quick facts

Lead sponsorNextStep Robotics Inc.
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment140
Start date20 August 2020
Primary completion28 February 2025
Estimated completion28 February 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

NextStep Robotics Inc.

Who can join

18 and older, any sex, with Foot Drop or Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Adaptive control ankle robotics training durably improves gait biomechanics in chronic hemiparetic stroke and footdrop.
    Roy A, Hennessie B, Hafer-Macko C, Forrester LW, et al · · 2025 · PMID 41462280 · DOI 10.1186/s12984-025-01834-2
  2. Dorsiflexion Specific Ankle Robotics to Enhance Motor Learning After Stroke: A Preliminary Report
    Roy A, Hennessie B, Hafer-Macko C, Westlake K, et al · · 2024 · DOI 10.21203/rs.3.rs-4390770/v1

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