Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Control

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Stroke SurvivorsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

10 meter walk test (10MWT)

This measures the individual's preferred overground walking speed, indicating their physical capability with an exoskeleton device

Time frame
2 weeks
2

6-minute walk test (6MWT)

This measures the individual's walking distance over 6 minutes to assess aerobic endurance.

Time frame
2 weeks
3

Physiological Cost Index

This measures the individual's oxygen consumption while walking. It will be calculated using a 6-minute walk test (6MWT) and heart rate.

Time frame
2 weeks
4

Borg Rating of Perceived Exertion (RPE)

This measures the individual's perceived physical activity intensity level, indicating how hard the individuals believes their body is working to conduct walking tasks with and without the exoskeleton devices.

Time frame
2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Georgia Institute of Technology

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: