StrokePOETSNCT04241848
Powered Orthotic Exoskeleton Training in Stroke
A study testing Keeogo and Ambulation training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Stroke
- What is being tested?
- Keeogo and Ambulation training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 30 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and female between 18 and 89 years old;
- Hemiplegia or hemiparesis due to stroke (>6 months);
- [Able to walk between 0.15-0.75m/s]
- Self-reported limitations to mobility and walking activities due to paretic side knee stiffness and loss of range of motion;
- Weight under 250lbs
- Desire to increase daily activity levels; and
- Able and willing to commit to participation and follow directions and communicate basic needs.
Who cannot join
- Neurological paralysis causing an inability to stand, weight bear or take stepping movements;
- Fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities;
- Modified Ashworth Scale for spasticity greater than 3 in the lower limbs
- Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the Six Minute Walk Test (6MWT)
- Anthropometric incompatibility with the device
- Femur length less than 36 cm or greater than 45 cm;
Show all 14Show fewer
- Upper thigh circumference less than 55 cm or greater than 75 cm;
- Lower thigh circumference less than 27 cm or greater than 40 cm;
- Calf circumference less than 33 cm or greater than 49 cm;
- Ankle circumference less than 27 cm or greater than 40 cm;
- Shin length less than 26 cm;
- Waist circumference less than 71 cm or greater than 107 cm;
- Any medical complication or co-morbidity as judged by the study physician to be contraindicated for wearing the device or walking (e.g., cardiovascular disorders, pressure ulcers, open wounds, lower limb vascular disorders, or other medical conditions); and
- Pregnant or planning to become pregnant (Females only).
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
About this study
Official title: Use of a Powered Orthotic Exoskeleton to Promote Mobility Through Improved Squat, Knee Flexion and Loading of the Paretic Leg in Persons With Chronic Stroke
Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.
Read the detailed description
Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices are commercially available for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement.
This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide.
The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton. Additional exploratory outcome measures of QOL will be determined.
- Conditions
- Stroke
- Being tested
- Keeogo, Ambulation training
- Keywords
- Stroke, Exoskeleton Device, Walking, Neurological Rehabilitation, Paresis, Hemiplegia
- Medical subject headings
- Stroke, Paresis, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KeeogoDevice
A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements.
Ambulation trainingOther
Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety.
| Study group | Role | What they receive |
|---|---|---|
| Powered Orthotic Exoskeleton Training Group | Experimental | Participant in 36 session ambulation training using a powered orthotic exoskeleton. Receives: Device: Keeogo; Other: Ambulation training |
| Control Group | Active comparator | Participant in 36 session ambulation training without using a powered orthotic exoskeleton. Receives: Other: Ambulation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five Times Sit to Stand Test (5xSTS)
The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device. The test will also be used to assess a level of improved function not while wearing the device.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Secondary outcomes (8)
Energy Expenditure
A portable metabolic cart will assess oxygen consumption during the two ambulation conditions (i.e., with and without the device) over a 6-minute period
Measured: Change from Baseline after completing 36 training sessions (approximately 3 months time)
The Ratio of Stance Time of Each Limb During Ambulation
Stepping parameters will be assessed using an instrumented carpet to determine if the paretic limb has more equitable and symmetrical load.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Six Minute Walk Test (6MWT)
The 6MWT was used to assess walking endurance and was conducted on a straight 12-meter length in the hospital hallway, with a small cone marking each end of the length. Participants were instructed to walk as far as possible, at a self-selected comfortable pace, for 6 minutes while a trainer followed behind them. Participants were allowed to slow down, stop, and rest if necessary if they felt fatigued during the test. The number of completed lengths (of the 12-meter stretch of the hospital hallway) was recorded and the distance in meters was calculated.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Ten Meter Walk Test (10MWT)
The 10MWT was used to assess gait speed. Participants were instructed to walk at their own comfortable pace along a 14-meter flat course in the hospital hallway while a trainer followed behind them. The initial and final two meters were used for acceleration and deceleration, respectively, while the middle ten meters of the course were times in seconds. Participants were allowed two trails, and the fastest elapsed time was used to calculate gait speed in meters/seconds.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Timed Up and Go (TUG) Test
The Timed Up and Go (TUG) Test was used as a reliable, objective measure of functional mobility. The participant was seated, with their back against the seatback, in a free-standing straight-backed chair with arms and a seat height of 17 inches. Participants were instructed to stand, walk three meters at a comfortable pace to a marked line, turn, walk back to the chair, and sit down. Timing started at the "start" command and stopped when the participant's buttocks touched the chair. Participants were allowed one practice trial prior to the timed trial.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Step Length of Paretic (Pa) Lower Extremities (LE)
Step lengths of the paretic (Pa) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Step Length of Non-paretic (NP) Lower Extremities (LE)
Step lengths of the non-paretic (NP) Lower Extremities were objective indices of spatiotemporal gait quality and were assessed with an instrumented pressure carpet (GaitRite Carpet, CIR Systems Inc., Franklin, NJ). Participants were instructed to walk at a comfortable, self-selected pace on a sensor equipped carpet that provided step length among other parameters. At least six consecutive steps on the carpet were needed to calculate the spatiotemporal parameters of the participant's gait.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Stair Climb Power Test (SCPT)
The Stair Climb Power Test was used as a measure of lower extremity (LE) power and functional mobility. Participants were instructed to ascend a flight of 10 stairs as fast as possible, using the handrail as needed for safety. Participants stood at the base of the first step. Timing started on the assessor's "go" command and stopped when both feet of the participant reached the top of the tenth step.
Measured: Change from Baseline after completing 36 training sessions (approximately three months time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start2 Nov 2020
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Ambulation training while using the powered orthotic exoskeleton for 36 sessions
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ann M Spungen, EdD, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241848
- Sponsor's protocol ID
- A3299-P
- Other IDs
- I21RX003299
- Acronym
- POETS
- Status last verified
- May 2025
- First submitted
- 30 Dec 2019
- Last updated
- 10 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Where practicable, sharing should take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Powered Orthotic Exoskeleton to Promote Mobility Through Improved Squat, Knee Flexion and Loading of the Paretic Leg in Persons With Chronic Stroke
- ClinicalTrials.gov ID
- NCT04241848
- Acronym / sponsor ID
- POETS / A3299-P
- Conditions
- Stroke
- Keywords
- Stroke, Exoskeleton Device, Walking, Neurological Rehabilitation, Paresis, Hemiplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 27 Jan 2020 (actual)
- Results
- Posted 10 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Veterans who suffer strokes often have disturbances in the ability to walk that reduces independence and quality of life. Alterations in gait combined with general decreased activity are associated with reduced muscle strength of the paretic leg. This leads to cardiovascular deconditioning and reduced quality of life. There is a new and novel battery powered device (Keeogo powered orthotic exoskeleton) that uses motors that assist knee movement while walking, sitting down, and standing up. The Keeogo monitors hip movement to assist the knee, making it simple to learn how to use. If successful, this project will show how this device will help improve the ability to walk and provide evidence to support larger clinical trials in a home and community setting to improve mobility, increase muscle mass and strength in the legs, as well as improve general health and quality of life. Lastly, this device could be used to increase motivation and confidence in a person to walk for longer periods of time and distance, providing the ability to walk in places that were previously inaccessible.
Detailed description
Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices are commercially available for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement.
This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide.
The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton. Additional exploratory outcome measures of QOL will be determined.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ambulation training while using the powered orthotic exoskeleton for 36 sessions
| Arm | Type | Receives |
|---|---|---|
| Powered Orthotic Exoskeleton Training Group | Experimental | Device: Keeogo, Other: Ambulation trainingParticipant in 36 session ambulation training using a powered orthotic exoskeleton. |
| Control Group | Active comparator | Other: Ambulation trainingParticipant in 36 session ambulation training without using a powered orthotic exoskeleton. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and female between 18 and 89 years old;
- Hemiplegia or hemiparesis due to stroke (>6 months);
- [Able to walk between 0.15-0.75m/s]
- Self-reported limitations to mobility and walking activities due to paretic side knee stiffness and loss of range of motion;
- Weight under 250lbs
Key exclusion criteria (14 listed)
- Neurological paralysis causing an inability to stand, weight bear or take stepping movements;
- Fixed contractures resulting in limited range of motion in the hip, knees, or ankles that prevent sitting, standing, walking, and/or squatting activities;
- Modified Ashworth Scale for spasticity greater than 3 in the lower limbs
- Able to walk at a normal walking speed (1.4 m/s, 3.2 mph) or better during the Six Minute Walk Test (6MWT)
- Anthropometric incompatibility with the device
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 |
|---|---|---|
| KeeogoA new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements. | Device | Powered Orthotic Exoskeleton Training Group |
| Ambulation trainingAmbulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety. | Other | Control Group, Powered Orthotic Exoskeleton Training Group |
Primary outcome
Five Times Sit to Stand Test (5xSTS)
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
The 5xSTS is used to determine leg power and an aspect of transfer skill. This test will be used to assess a level of improved function while wearing the device. The test will also be used to assess a level of improved function not while wearing the device.
8 secondary outcomes
Energy Expenditure
Time frame: Change from Baseline after completing 36 training sessions (approximately 3 months time)
The Ratio of Stance Time of Each Limb During Ambulation
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Six Minute Walk Test (6MWT)
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Ten Meter Walk Test (10MWT)
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Timed Up and Go (TUG) Test
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Step Length of Paretic (Pa) Lower Extremities (LE)
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Step Length of Non-paretic (NP) Lower Extremities (LE)
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Stair Climb Power Test (SCPT)
Time frame: Change from Baseline after completing 36 training sessions (approximately three months time)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Where practicable, sharing should take place under a written agreement prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. However, it is permissible for final datasets in machine-readable format to be submitted to and accessed from PubMed Central (and similar sites) provided that care is taken to ensure that the individuals cannot be re-identified using other publicly available information.
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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.
Ann M Spungen, EdD principal investigator
James J. Peters Veterans Affairs Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Keeogo and Ambulation training in people with Stroke, run by VA Office of Research and Development at 1 site 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 14 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 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 10 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Five Times Sit to Stand Test (5xSTS) (time frame: Change from Baseline after completing 36 training sessions (approximately three months time)). 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 10 Jun 2025; AzTrials last refreshed its copy on 27 Oct 2026.