Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-22

Study Completion Date

2020-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating the Indego Exoskeleton for Persons With Hemiplegia Due to CVA

NCT03054064

Cerebrovascular Accident (CVA) Stroke Hemiplegia

COMPLETED NA

Powered Orthotic Exoskeleton Training in Stroke

NCT04241848

Stroke

COMPLETED NA

Mobility Training Using Exoskeletons for Functional Recovery After Stroke

NCT02128152

Severe Stroke or Similar Neurological Muscle Weakness

ACTIVE_NOT_RECRUITING NA

Hand Exoskeleton Training Study

NCT06786858

Stroke

RECRUITING NA

Safety Evaluation of the ReWalk ReStore Device in Subjects With Mobility Impairments Due to Stroke

NCT03499210

Stroke Stroke, Acute Stroke Hemorrhagic +3 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Ischemic Stroke Hemorrhagic Stroke Hemiparesis Cerebral Vascular Accident

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Sites will enroll participants in order of recruitment. No other randomization procedure will be applied.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Keeogo™ Dermoskeleton

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.

Group Type EXPERIMENTAL

Keeogo™ Dermoskeleton

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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)
* 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.

Exclusion Criteria

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
* 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;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No