Powered Orthotic Exoskeleton Training in Stroke — POETS  

Stroke Clinical Trial

Official title: Use of a Powered Orthotic Exoskeleton to Promote Mobility Through Improved Squat, Knee Flexion and Loading of the Paretic Leg in Persons With Chronic Stroke

Status Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices are commercially available for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement. This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide. The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton. Additional exploratory outcome measures of QOL will be determined. ;

Related Conditions & MeSH terms

• Stroke

• NCT number: NCT04241848
• Study type: Interventional
• Source: VA Office of Research and Development
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2, 2020
• Completion date: June 30, 2024