NCT03264235

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	Traditional Stair Training	Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.

Timeline

• Start date: 2017-08-30
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2017-08-29
• Last updated: 2024-01-25

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study