Powered Orthotic Exoskeleton Training in Stroke

NCT04241848 | Completed Results FDA Device

• 2 other identifiers: A3299-PI21RX003299
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stroke; Exoskeleton Device; Walking; Neurological Rehabilitation; Paresis; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Five Times Sit to Stand Test (5xSTS)

  The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device. The test will also be used to assess a level of improved function not while wearing the device.

  Change from Baseline after completing 36 training sessions (approximately three months time)

Secondary Outcomes (8)

• Energy Expenditure

  Change from Baseline after completing 36 training sessions (approximately 3 months time)

• The Ratio of Stance Time of Each Limb During Ambulation

  Change from Baseline after completing 36 training sessions (approximately three months time)

• Six Minute Walk Test (6MWT)

  Change from Baseline after completing 36 training sessions (approximately three months time)

• Ten Meter Walk Test (10MWT)

  Change from Baseline after completing 36 training sessions (approximately three months time)

• Timed Up and Go (TUG) Test

  Change from Baseline after completing 36 training sessions (approximately three months time)

Study Arms (2)

Powered Orthotic Exoskeleton Training Group

EXPERIMENTAL

Participant in 36 session ambulation training using a powered orthotic exoskeleton.

Device: Keeogo; Other: Ambulation training

Control Group

ACTIVE COMPARATOR

Participant in 36 session ambulation training without using a powered orthotic exoskeleton.

Other: Ambulation training

Interventions

Keeogo DEVICE

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.

Powered Orthotic Exoskeleton Training Group

Ambulation training OTHER

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.

Control Group; Powered Orthotic Exoskeleton Training Group

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and female between 18 and 89 years old;
• Hemiplegia or hemiparesis due to stroke (\>6 months);
• \[Able to walk between 0.15-0.75m/s\]
• Self-reported limitations to mobility and walking activities due to paretic side knee stiffness and loss of range of motion;
• Weight under 250lbs
• Desire to increase daily activity levels; and
• Able and willing to commit to participation and follow directions and communicate basic needs.

You may not qualify if:

• Neurological paralysis causing an inability to stand, weight bear or take stepping movements;
• Fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities;
• Modified Ashworth Scale for spasticity greater than 3 in the lower limbs
• Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the Six Minute Walk Test (6MWT)
• Anthropometric incompatibility with the device
• Femur length less than 36 cm or greater than 45 cm;
• Upper thigh circumference less than 55 cm or greater than 75 cm;
• Lower thigh circumference less than 27 cm or greater than 40 cm;
• Calf circumference less than 33 cm or greater than 49 cm;
• Ankle circumference less than 27 cm or greater than 40 cm;
• Shin length less than 26 cm;
• Waist circumference less than 71 cm or greater than 107 cm;
• Any medical complication or co-morbidity as judged by the study physician to be contraindicated for wearing the device or walking (e.g., cardiovascular disorders, pressure ulcers, open wounds, lower limb vascular disorders, or other medical conditions); and
• Pregnant or planning to become pregnant (Females only).

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

MeSH Terms

Conditions

Stroke; Paresis; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Limitations and Caveats

We were approved to begin this study during the summer of 2020, which was during the first wave of the COVID-19 pandemic. Due to the lockdown status of our VAMC at that time, no participants were permitted to be enrolled. In late April 2021, most restrictions were lifted at our VAMC, and we were able to begin the process of enrolling the targeted number of participants. The delayed start to study procedures, however, led to a smaller than anticipated number of subjects available for analysis.

Results Point of Contact

• Title: Dr. Ann Spungen
• Organization: James J. Peters VA Medical Center, Spinal Cord Damage Research Center

Ann.Spungen@va.gov

(718) 584-9000

Study Officials

• Ann M Spungen, EdD

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Ambulation training while using the powered orthotic exoskeleton for 36 sessions

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 27, 2020
• Study Start: November 2, 2020
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: June 10, 2025
• Results First Posted: June 10, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)