Robotic Exoskeleton Assisted Gait Post Stroke

Conditions

• CVA
• Gait, Hemiplegic

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• EksoGT™, Ekso Bionics, Berkley, CA, USA — DEVICE
  The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking.
• Standard of Care — OTHER
  Standard gait therapy provided by licensed physical therapists post stroke.
• No Intervention — OTHER
  Testing Only

Study Details

The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.

Key Dates

Start date

Jan 30, 2020

Status verified

Apr 2025

Primary completion

May 1, 2026

Completion

Sep 1, 2026

Study Design

Enrollment

75 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Stroke RE
  After discharge from the acute rehabilitation facility, participants in the stroke RE group will participate 3 days a week for 10 weeks in robotic exoskeleton gait training provided by a trained, licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own.
• Active Comparator: Stroke SOC
  After discharge from the acute rehabilitation facility, participants in the stroke SOC group will participate 3 days a week for 10 weeks in standard of care gait training provided by a licensed physical therapist. Participants will be permitted to participate in additional prescribed standard physical therapy on their own.
• Other: Healthy Control
  Participants in the healthy control group will not participate in any gait training. Healthy control participants will only be asked to complete 3 testing sessions.

Primary Outcome Measure

Functional Independence Measure (FIM) (aim 1) [ Time Frame: Change from Baseline FIM at 10 weeks ]

Locations (1)

Find similar trials in West Orange, NJ

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