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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

  • 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)
Show all 20Show fewer
  • 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
Show all 11Show fewer
  • 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

Other trials in United States

Canada1 site

  • Assistive Technology Clinic (ATC)

    Toronto, Ontario, M6A 2E1

Other trials in Canada

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 groups in NCT03986320
Study groupRoleWhat they receive
Keeogo™ DermoskeletonExperimentalKeeogo™ 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.

  1. 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)

  1. 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

  2. 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

  3. 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.

  1. First posted14 Jun 2019
  2. Study start22 Jul 2019
  3. Primary completion20 Mar 2020
  4. Study completion10 Sep 2020

Resources

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)
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 26289955

  • Xu 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 30248015

  • He 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 28533700

  • Lee 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 29183379

  • Morawietz 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

Questions about this trial

What is this clinical trial studying?

A study testing Keeogo™ Dermoskeleton in people with Stroke, Ischemic and Stroke Hemorrhagic, run by B-Temia, Inc. at 4 sites in 2 countries.

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 20 inclusion and 11 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 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Canada. 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?

Incidence of device-related adverse events [Safety] (time frame: Duration of study participation for each subject, estimated 3-5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03986320, which also lists 5 linked publications.

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 30 Sep 2026.

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