Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke

Conditions

• Stroke

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Control — OTHER
  The stroke survivors will serve as their own control group. The participants will complete the required tasks without an exoskeleton device.
• Hip Exoskeleton — DEVICE
  The Georgia Tech Hip Exo is a wearable robotic device for hip extension/flexion assistance. This device will be used to study the lower limb movement and how to effectively assist users. It makes use of a responsive controller that considers information such as joint angles to understand the user's state and assists with the appropriate level of power accordingly.
• Ankle Exoskeleton — DEVICE
  The Dephy Exoboot is a lower limb exoskeleton which attaches to the user below the knee through a cuff at the proximal calf and a provided shoe. This investigational device is used to make it easier for able-bodied and impaired individuals to walk and run under a variety of conditions. The exoskeleton provides assistance at the ankle joint during movement. The purpose is to assist the user in lower limb movements such as ground level walking, climbing stairs/ramps, and sit-to-stand.

Study Details

An exoskeleton device is a robotic system designed to improve an individual's ability to move and perform tasks encountered in everyday situations. These devices consist of external rigid limb segments that assists humans through different body movements with the use of actuators. These devices are controlled by an onboard computer that determines the timing and magnitude of assistance deployed to the user. Exoskeleton controller performance is key to providing beneficial assistance that does not inhibit the user's movement. Preceding work will compare the benefit of personalized hip versus ankle joint exoskeleton assistance for improvement of post-stroke gait. It will combine exoskeleton technology with the user's movement feedback to improve wearable robotic assistance to an individual stroke survivor's gait pattern. For the clinical trial research covered under this protocol, the investigator will test various exoskeleton technologies with stroke survivors in real-world contexts, indoors and outdoors, and measure clinically meaningful outcomes and user perceptions regarding technology usability and adoption. The long-term goal is to deploy self-adaptive, adoptable exoskeletons for personalized assistance during community ambulation.

Key Dates

Start date

Jan 1, 2027

Status verified

Nov 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Stroke Survivors
  This study will be divided into 2 sessions that will occur on 2 separate days: 1) Hip Exoskeleton session and 2) Ankle Exoskeleton session. In each session, subjects will undergo two conditions in which they complete the outcomes measures 1) while wearing the exoskeleton and 2) in a baseline condition without the exoskeleton. Order of condition and session will be randomized. Prior to the exoskeleton condition, subjects will be allowed time to acclimate to the device during a walking session on the treadmill. Subjects will complete several timed walking tests both indoors and outdoors. Measurements of energy expenditure may also be recorded along with patient reported outcomes data to assess participant perception of their performance with and without the devices.

Primary Outcome Measure

10 meter walk test (10MWT) [ Time Frame: 2 weeks ]

Central Contacts

• Aaron Young, PhD
  404-385-5306
  [email protected]
• Greg Sawicki, PhD
  404-385-5706
  [email protected]

Locations (1)

Find similar trials in Atlanta, GA

Related Studies

• GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
  Recruiting · W.L.Gore & Associates · Tucson, Arizona
• Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG
  PHASE3 · Recruiting · Icahn School of Medicine at Mount Sinai · Little Rock, Arkansas
• Stroke Thrombectomy and Aneurysm Registry
  Recruiting · Medical University of South Carolina · Birmingham, Alabama
• The CONFORM Pivotal Trial
  Recruiting · Conformal Medical, Inc · Birmingham, Alabama