Stroke, IschemicNCT03986320
Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
A study testing Keeogo™ Dermoskeleton in people with Stroke, Ischemic and Stroke Hemorrhagic, run by B-Temia, Inc. at 4 sites in 2 countries.
Trial summary
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Ischemic, Stroke Hemorrhagic, Stroke
- What is being tested?
- Keeogo™ Dermoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 22 Jul 2019to 10 Sep 2020
- Phase
- Interventional
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
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Provide signed and dated informed consent form;
- Willing to comply with all study procedures and be available for the duration of the study [2-3 days per week, 3-5 consecutive weeks];
- Adults 18 years of age and older;
- Confirmed Cerebrovascular Accident (CVA) with hemiparesis;
- Stable stroke (≥ 6 months post-incident)
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- Sufficient cognition to follow simple instructions and understand the content and purpose of the study (MMSE > 20);
- Capable of standing and walking independently for an extended period of time (MMT
- 3 hip flexors and extensors, and ≥ 2 knee flexors and extensors with BBS ≥ 45);
- Presence of any gait deficit, as defined by one or more of the following clinical observations:
- Hip hike
- Hip circumduction
- Knee spasticity (MAS 2 to 3) as per Modified Ashworth Scale (MAS)
- Mid-foot striking (aka 'flat foot landing')
- Poor foot clearance (toe/foot drop or foot drag)
- Narrow steps (< 1 shoe-width or < 8 cm)
- Manual Muscle Test (MMT) of 4/5 for the unaffected upper extremity;
- Able to sit on a bench for more than 5 minutes;
- Is physically and mentally compatible with device to demonstrate ability to safely activate the Keeogo™ user interface;
- Able to understand and follow instructions with assistance if needed.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Legally blind
- Pregnant, lactating, or postpartum sacroiliac joint recovery is ongoing (recent childbirth, not yet cleared for vigorous exercise)
- Skin condition that contraindicates use of orthotics or support braces
- Recent (<6 mo) lower-body hospitalizations or active treatments due to a joint, muscle, bone, nerve or vascular injury or condition
- Scheduled for major surgery within next 4 months
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- Lower-extremity amputation above or below the knee
- Have uncontrolled hypertension
- Recent (<1 year) heart attack
- Have uncontrolled diabetes
- Diagnosed with other health condition(s) that affect mobility and balance; chronic obstructive pulmonary disease; peripheral arterial disease; vestibular disorders; cerebellar disease; cerebral palsy; muscular dystrophy spinal cord injury; other brain injury aside from the reported CVA;
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Shirley Ryan Ability Lab (SRA)
Chicago, Illinois, 60611
James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury
The Bronx, New York, 10468
Human Performance and Engineering Research (HPER)
West Orange, New Jersey, 07052
About this study
Official title: A Multi-site, Interventional, Comparative, Single-arm Trial to Evaluate the Safety and Effectiveness of Keeogo™ Dermoskeleton in Subjects With Hemiparesis Due to Ischemic or Hemorrhagic Stroke.
A multi-site, interventional, non-comparative, single-arm trial to evaluate the safety of the Keeogo™ Dermoskeleton in subjects with hemiparesis due to ischemic or hemorrhagic stroke.
Read the detailed description
Stroke affects thousands of individuals annually, leading to considerable physical impairment and functional disability. Gait is one of the most important activities of daily living affected in this patient population. Recent technological developments in passively powered dermoskeleton can create powerful adjunctive tools for rehabilitation and potentially accelerate functional recovery. Here, the investigators present the development and evaluation of a lower limb dermoskeleton, namely Keeogo™ (B-Temia), for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions.
Keeogo™ Dermoskeleton is a low-profile, assistive exoskeleton (or 'dermoskeleton') that orthotically fits to the lower limbs. Keeogo™ is worn on the user's lower body using a belt and contact areas attached around the thighs and calves.
- Being tested
- Keeogo™ Dermoskeleton
- Keywords
- Keeogo™, Dermoskeleton, Powered dermoskeleton, Lower limb dermoskeleton, Assistive exoskeleton, Orthotic dermoskeleton
- Medical subject headings
- Ischemic Stroke, Hemorrhagic Stroke, Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Keeogo™ DermoskeletonDevice
This device is intended for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions.
| Study group | Role | What they receive |
|---|---|---|
| Keeogo™ Dermoskeleton | Experimental | Keeogo™ Dermoskeleton is a low-profile, assistive exoskeleton (or 'dermoskeleton') that orthotically fits to the lower limbs. Keeogo™ is worn on the user's lower body using a belt and contact areas attached around the thighs and calves. Receives: Device: Keeogo™ Dermoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of device-related adverse events [Safety]
Safety will be evaluated on the basis of the number of device-related serious adverse events reported for subjects during their participation in the study.
Measured: Duration of study participation for each subject, estimated 3-5 weeks
Secondary outcomes (3)
Incidence of device malfunctions during study procedures [Device Reliability]
Device reliability will be evaluated on the basis of the number of device malfunctions reported by research study staff for the duration of study procedures at each study site.
Measured: Duration of study completion for each site, estimated 3-5 weeks
Incidence of injury to Physical Therapist (PT) caused by device [PT safety]
PT safety will be evaluated on the basis of the number of serious device-related injuries reported by study physical therapists for the duration of study procedures at each study site.
Measured: Duration of study completion for each site, estimated 3-5 weeks
Device, Effectiveness
Clinician and Patient Reported Outcomes (surveys) will be used to assess the effectiveness of the device in assisting gait. The surveys will rate subject performance in walking based on clinician observed deviations and subject perception of mobility limitation due to the stroke.
- Device effectiveness will be measured based on statistical analysis of the survey data between conditions (baseline compared to device-use) Ratings by the surveys will be validated using instrumented walkway and image data collected during walking.
Measured: Duration of study participation for each subject, estimated 3-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2019
- Study start22 Jul 2019
- Primary completion20 Mar 2020
- Study completion10 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Stroke, IschemicStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device: Keeogo™ Dermoskeleton This device is intended for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- B-Temia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arun Jayaraman, PT, PhD., Principal investigator, Shirley Ryan Ability Lab (SRA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03986320
- Sponsor's protocol ID
- KEOG-SE-002
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2019
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Buesing C, Fisch G, O'Donnell M, Shahidi I, Thomas L, Mummidisetty CK, Williams KJ, Takahashi H, Rymer WZ, Jayaraman A. Effects of a wearable exoskeleton stride management assist system (SMA(R)) on spatiotemporal gait characteristics in individuals after stroke: a randomized controlled trial. J Neuroeng Rehabil. 2015 Aug 20;12:69. doi: 10.1186/s12984-015-0062-0.
PubMed 26289955Xu J, Murphy SL, Kochanek KD, Bastian B, Arias E. Deaths: Final Data for 2016. Natl Vital Stat Rep. 2018 Jul;67(5):1-76.
PubMed 30248015He Y, Eguren D, Luu TP, Contreras-Vidal JL. Risk management and regulations for lower limb medical exoskeletons: a review. Med Devices (Auckl). 2017 May 9;10:89-107. doi: 10.2147/MDER.S107134. eCollection 2017.
PubMed 28533700Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.
PubMed 29183379Morawietz C, Moffat F. Effects of locomotor training after incomplete spinal cord injury: a systematic review. Arch Phys Med Rehabil. 2013 Nov;94(11):2297-308. doi: 10.1016/j.apmr.2013.06.023. Epub 2013 Jul 9.
PubMed 23850614