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

Shirley Ryan AbilityLab

Status: Completed

Conditions: Gait Disorders, Neurologic; Stroke, Acute

Treatments: Device: Keeogo; Other: Traditional Stair Training

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03264235

NUSTU00205454

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Group 1 Exoskeleton

Experimental group

Description:

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.

Treatment:

Device: Keeogo

Group 2 Traditional Therapy

Active Comparator group

Description:

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

Treatment:

Other: Traditional Stair Training