An interventional study of Keeogo and Traditional Stair Training in Stroke, Acute and Gait Disorders, Neurologic, sponsored by Shirley Ryan AbilityLab. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
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.
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
Sessions 2 through 6: Training
Session 7: Post-Testing
Exclusion Criteria:
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 will complete traditional stair training in inpatient physical therapy.
Other: Traditional Stair Training
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.
Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 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.
Time frame: Initial Visit (Week 1); Post testing (Week 2)
5-times Sit to Stand Test
Method: Use a straight back chair with a solid seat that is 16" high. Ask participant to sit on the chair with arms folded across their chest. Instructions: "Stand up and sit down as quickly as possible 5 times, keeping your arms folded across your chest." Measurement: Stop timing when the participant stands the 5th time.
Time frame: Initial Visit (Week 1); Post testing (Week 2)
GAITRite Data Collection
The GAITRite system automates measuring temporal and spatial gait parameters via an electronic walkway connected to a computer. The GAITRite electronic walkway contains sensor pads encapsulated in a carpet to collect gait information. The system can be laid over any flat surface. The GAITRite electronic walkway for the study shall be a minimum of 14 feet long. The GAITRite data capture was chosen as measurement of the patient's overall gait quality. Patients will be asked to walk at a self-selected speed across the GAITRite electronic walkway with at least a two meter "flying start" to compensate for initial acceleration.
Time frame: Initial Visit (Week 1); Post testing (Week 2)
Plan to share: No
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This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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