Clinical Efficacy of Exoskeleton Assistance for Individuals Post-Stroke

ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorGeorgia Institute of Technology

About this trial

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.

Eligibility criteria

Qualifiers

Between 18-85 years of age

Stroke at least 6 months prior to study involvement

Community dwelling (participant does not live in an assisted living facility)

Able to provide informed consent to participate in the study activities

Disqualifiers

Requires a walker to walk independently

Has a shuffling gait pattern overground

Has a Functional Ambulation Category (FAC) score of 2 or lower (the participant requires the assistance of another person in order to walk)

Has a significant secondary deficit beyond stroke (e.g. amputation, legal blindness or other severe impairment or condition) that in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results

Trial design

Treatments tested in this trial

  • Control
  • Hip Exoskeleton
  • Ankle Exoskeleton

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Georgia Institute of Technology

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator