Powered Orthotic Exoskeleton Training in Stroke

Summary

Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.

Conditions

• Stroke

Interventions

DEVICE

Keeogo

A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements.

OTHER

Ambulation training

Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Ann M Spungen, EdD · James J. Peters Veterans Affairs Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-02

Primary Completion

2024-05-30

Completion

2024-05-30

FDA Device

Yes

Countries

• United States

Study Locations