Stroke, AcuteNCT03264235
The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute CVA
A study testing Keeogo and Traditional Stair Training in people with Stroke, Acute and Gait Disorders, Neurologic, run by Shirley Ryan AbilityLab at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute, Gait Disorders, Neurologic
- What is being tested?
- Keeogo and Traditional Stair Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2017to 30 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Shirley Ryan Ability Lab
Chicago, Illinois, 60611
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
About this study
Official title: The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
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.
Read the 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
- Being tested
- Keeogo, Traditional Stair Training
- Keywords
- Powered-Knee Exoskeleton, Stair Training, Keeogo
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeeogoDevice
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.
Traditional Stair TrainingOther
Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Keeogo |
| Group 2 Traditional Therapy | Active comparator | Group 2 will complete traditional stair training in inpatient physical therapy. Receives: Other: Traditional Stair Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial Visit (Week 1); Post testing (Week 2)
Secondary outcomes (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.
Measured: 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.
Measured: Initial Visit (Week 1); Post testing (Week 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start30 Aug 2017
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PhD, Principal investigator, Shirley Ryan Ability Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264235
- Sponsor's protocol ID
- NUSTU00205454
- Status last verified
- Jan 2024
- First submitted
- 9 Aug 2017
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Powered-Knee Exoskeleton Assist on Stair Climbing in Acute Cerebrovascular Accidents
- ClinicalTrials.gov ID
- NCT03264235
- Acronym / sponsor ID
- NUSTU00205454
- Conditions
- Stroke, Acute, Gait Disorders, Neurologic
- Keywords
- Powered-Knee Exoskeleton, Stair Training, Keeogo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group 1 Exoskeleton | Experimental | Device: KeeogoBoth 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 2 Traditional Therapy | Active comparator | Other: Traditional Stair TrainingGroup 2 will complete traditional stair training in inpatient physical therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KeeogoKeeogo 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. | Device | Group 1 Exoskeleton |
| Traditional Stair TrainingIndividuals will participate in traditional stair training physical therapy for the same duration of time as Group 1. | Other | Group 2 Traditional Therapy |
Primary outcome
Change in Timed Stair Climb Test speed from baseline
Time frame: Initial Visit (Week 1); Post testing (Week 2)
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.
2 secondary outcomes
5-times Sit to Stand Test
Time frame: Initial Visit (Week 1); Post testing (Week 2)
GAITRite Data Collection
Time frame: Initial Visit (Week 1); Post testing (Week 2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PT, PhD principal investigator
Shirley Ryan Ability Lab
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keeogo and Traditional Stair Training in people with Stroke, Acute and Gait Disorders, Neurologic, run by Shirley Ryan AbilityLab at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Timed Stair Climb Test speed from baseline (time frame: Initial Visit (Week 1); Post testing (Week 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2024.