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

NCT ID: NCT03264235

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-30
• Study Completion Date: 2023-08-30

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.

Detailed Description

Participants will be randomized into one of two groups. Group 1 will wear the exoskeleton device while completing all training sessions. Group 2 will not wear the exoskeleton device during training sessions. All screening and evaluation sessions will be completed without the exoskeleton device for both Group 1 and Group 2. Pre and post-session vitals (blood pressure, heart rate) will be taken and monitored throughout the session as needed. Gait belts and/or overhead track and harnessing systems will be used throughout sessions as needed for increased safety of participants. Skin integrity will also be monitored both before and after each use of the exoskeleton device.

Each enrolled participant will complete the following sessions:

Session 1: Screening

• After consenting, subjects will undergo a physical evaluation and screening exam by a licensed physical therapist. If they meet study criteria, they will be randomly placed into either the Keeogo group or the traditional stair training group using a random number generator and they will be entered into the study. Once they are enrolled, baseline outcome measures will be assessed.

Sessions 2 through 6: Training

• Subjects will participate in 30 minutes of stair training with or without the exoskeleton device, depending on group assignment.

Session 7: Post-Testing

• Outcomes measures will once again be assessed by a licensed physical therapist.

Conditions

Stroke, Acute; Gait Disorders, Neurologic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 Exoskeleton

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.

Group Type: EXPERIMENTAL

Keeogo

Intervention Type: 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 2 Traditional Therapy

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

Group Type: ACTIVE_COMPARATOR

Traditional Stair Training

Intervention Type: OTHER

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

Interventions

Keeogo

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.

Intervention Type: DEVICE

Traditional Stair Training

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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
• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Department of Education

FED

Sponsor Role: collaborator

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

Arun Jayaraman, PT, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arun Jayaraman, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan Ability Lab

Locations

Shirley Ryan Ability Lab

Chicago, Illinois, United States

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Countries

United States

Other Identifiers

NUSTU00205454

Identifier Type: -

Identifier Source: org_study_id