Post Stroke Ambulation Recovery Using Robotic Exoskeletons

Part of paid clinical trials in West Orange, New Jersey.

Sponsor
Kessler Foundation
Study ID
NCT06736171
Status
Recruiting
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Conditions

  • Hemiparesis After Stroke

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic Exoskeleton — DEVICE
    EksoNR, Ekso Bionics, San Rafael, CA, USA Atalante X, Wandercraft, Paris, France ReStore™, Lifeward Inc, Marlborough, MA
  • SOC — OTHER
    Standard of Care

Study Details

The purpose of this research study is to evaluate and compare different robotic exoskeletons (RE) and identify which is most appropriate for gait training for each patient based off their specific needs. This will help guide clinicians in prescribing the appropriate RE for rehabilitation.

Key Dates

Start date
May 15, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2029
Completion
Jun 30, 2030

Study Design

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

Arms

  • Experimental: Stroke RE
    Participants in the stroke RE group will participate 3-4 weeks, 2-3 times a week for a total of 9 robotic exoskeleton gait training sessions provided by a trained, licensed physical therapist.
  • Active Comparator: Stroke SOC
    Participants in the stroke SOC group will participate 3-4 weeks, 2-3 times a week for a total of 9 standard of care gait training sessions provided by a trained, licensed physical therapist.

Primary Outcome Measure

10MWT (Aim 1) [ Time Frame: Change from Baseline 10MWT at 4 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Kessler FoundationWest OrangeNew Jersey07052
Sharon Franco
[email protected]
973-324-3521
Karen J Nolan, PhD (PRINCIPAL_INVESTIGATOR)
Kiran K Karunakaran, PhD (PRINCIPAL_INVESTIGATOR)

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