The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA

NCT03264235 | Completed DMC FDA Device

• 1 other identifier: NUSTU00205454
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Hypothesis/Specific Aims: The purpose of this research study is to determine if using an exoskeleton during stair climbing training will result in an improved ability to walk and climb stairs in individuals affected by recent stroke as compared to stair climbing training without an exoskeleton.

Conditions

Stroke, Acute; Gait Disorders, Neurologic

Keywords

Powered-Knee Exoskeleton; Stair Training; Keeogo

Outcome Measures

Primary Outcomes (1)

• Change in Timed Stair Climb Test speed from baseline

  The timed stair test is best conducted in a standard interior stair-well with guard rails and preferably 10 steps between landings, with a minimum of 8 steps and a maximum of 12 steps. The landing space is required to ensure safe turning. The patient will be instructed to ascend and descend the stair case "as quickly and safely" as possible. To start the test, the patient is asked to stand at the bottom of the stair case, and a countdown provided "one, two, ready, go" where the patient initiates stair ascent at the "go" cue, and the tester starts the stop watch. • The patient ascends the stair case, turns and descends the stair case, coming to a stop at the bottom of the stair case. The tester will lap the time for the ascent period and the descend period, and records these "Test 1" times. This will be repeated for a total of two trials.

  Initial Visit (Week 1); Post testing (Week 2)

Secondary Outcomes (2)

• 5-times Sit to Stand Test

  Initial Visit (Week 1); Post testing (Week 2)

• GAITRite Data Collection

  Initial Visit (Week 1); Post testing (Week 2)

Study Arms (2)

Group 1 Exoskeleton

EXPERIMENTAL

Both training groups will undergo inpatient physical therapy of the same duration and intensity. Group 1 will complete stair training wearing the Keeogo Exoskeleton in inpatient physical therapy.

Device: Keeogo

Group 2 Traditional Therapy

ACTIVE COMPARATOR

Group 2 will complete traditional stair training in inpatient physical therapy.

Other: Traditional Stair Training

Interventions

Keeogo DEVICE

Keeogo is a computer-controlled lower extremity motorized orthosis worn over the user's hips and legs. The controller box contains sensors that supply information about the kinematics and the kinetics of the user's lower extremities and includes software that recognizes the user's mobility intentions. The system is powered by a lithium-polymer battery. The leg brace assembly is mainly comprised of the actuator, the electronic boards, hip joint, and soft goods (cuffs, belts) for affixing the assembly to the user's legs. The waist belt comes in various sizes adapted to each wearer, and adds additional support of the device on the user. Keeogo does not initiate any movement but waits for the user's lead. Once the user makes the first move, Keeogo assists according to the activity. The individual must be able to initiate and terminate steps.

Group 1 Exoskeleton

Traditional Stair Training OTHER

Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.

Group 2 Traditional Therapy

Eligibility Criteria

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

You may qualify if:

• Patient in the inpatient rehabilitation setting
• less that 3 months post-hemorrhagic or ischemic cerebrovascular accident (CVA)
• No previous diagnosis or treatment for CVA
• Acute inpatient rehabilitation discharge goal of stair negotiation
• years of age or older
• Waist and leg circumference and lower extremity lengths appropriate for a comfortable and safe fit in the Keeogo study device
• Medical clearance from a Shirley Ryan AbilityLab (SRALAB) inpatient physician

You may not qualify if:

• Unwilling to participate
• Unable to provide autonomous consent due to cognitive or communication impairment
• Legally blind
• Pregnant or lactating
• Skin condition that contraindicates use of orthotics or support braces
• History of multiple CVA
• History of any additional neuropathology diagnosis, such as Parkinson's disease, multiple sclerosis, traumatic brain injury, or spinal cord injury

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• U.S. Department of Education: collaborator

Study Sites (2)

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

Location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic

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

Study Officials

• Arun Jayaraman, PT, PhD

  Shirley Ryan Ability Lab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions and will participate in 30 minutes of stair training in the device. Group 2 will not wear the exoskeleton device during training sessions and will be participate in 30 minutes of stair training without the device.

Study Record Dates

• First Submitted: August 9, 2017
• First Posted: August 29, 2017
• Study Start: August 30, 2017
• Primary Completion: August 30, 2023
• Study Completion: August 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)