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Feasibility and Safety of a Portable Exoskeleton to Improve Mobility in Parkinson's Disease

StatusCompleted
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fields
  2. Trial completed Final enrollment: 10 participants (planned 30) · Primary completion date changed from estimate of Aug 31, 2026 to Feb 25, 2026 · Eligibility criteria expanded, about 35 words · 3 more Show 6 more changesShow less
    • Final enrollment: 10 participants (planned 30)
    • Primary completion date changed from estimate of Aug 31, 2026 to Feb 25, 2026
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Study description revised
    • Site details revised
  3. Primary completion date: Aug 30, 2025 to Aug 31, 2026 Completion date: Dec 31, 2025 to Dec 31, 2026 · Eligibility criteria expanded, about 11 words · Secondary endpoints: 4 to 2 · 2 morev8 Show 5 more changesShow less
    • Completion date: Dec 31, 2025 to Dec 31, 2026
    • Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 4 to 2
    • Study description shortened, about 17 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Site details revisedv7 Show 1 more changeShow less
    • Site details revised
  5. Start date: Jul 15, 2024 to Sep 1, 2024 Primary completion date: Jun 30, 2025 to Aug 30, 2025v6 Show 1 more changeShow less
    • Primary completion date: Jun 30, 2025 to Aug 30, 2025
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: May 15, 2024 to Jul 15, 2024v5
  2. Start date: Apr 1, 2024 to May 15, 2024 Primary completion date: May 31, 2025 to Jun 30, 2025v4 Show 1 more changeShow less
    • Primary completion date: May 31, 2025 to Jun 30, 2025
  3. Start date: Feb 1, 2024 to Apr 1, 2024 Primary completion date: Dec 31, 2025 to May 31, 2025 · Site contact updatedv3 Show 2 more changesShow less
    • Primary completion date: Dec 31, 2025 to May 31, 2025
    • Site contact updated
  4. Start date: Oct 1, 2023 to Feb 1, 2024 Primary and study completion dates: Aug 31, 2025 to Dec 31, 2025v2 Show 1 more changeShow less
    • Primary and study completion dates: Aug 31, 2025 to Dec 31, 2025
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Physical therapy approaches for balance and walking deficits in Parkinson's disease (PD) have limited effectiveness, with mostly short-lasting benefits. An exoskeleton is a device that straps to the legs and provides a passive force to assist people to better ambulate. The goal of this study is to establish the feasibility and safety of a lightweight exoskeleton on mobility and fall reduction in people with PD. As most PD patients eventually require assistive mobility devices, the exoskeleton represents a new option for increased, mobility, quality of life, and independence. Qualified subjects will come to the clinic twice weekly for eight weeks (16 total visits) and wear the exoskeleton device while walking under the supervision of a trained kinesiotherapist. Study staff will also interview participants and assess their PD symptoms, quality of life, and overall mobility. This study hopes to establish exoskeletons as modern, standard of care devices, which allow people with PD to maintain more independent and productive lives.
Trial Details
NCT Number NCT06028529
Lead Sponsor VA Office of Research and Development
Conditions Parkinson's Disease
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov