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

NCT03986320 | Unknown FDA Device

• 1 other identifier: KEOG-SE-002
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief 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.

Conditions

Stroke, Ischemic; Stroke Hemorrhagic; Stroke; Hemiparesis; Cerebral Vascular Accident

Keywords

Keeogo™; Dermoskeleton; Powered dermoskeleton; Lower limb dermoskeleton; Assistive exoskeleton; Orthotic dermoskeleton

Outcome Measures

Primary Outcomes (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.

  Duration of study participation for each subject, estimated 3-5 weeks

Secondary Outcomes (3)

• Incidence of device malfunctions during study procedures [Device Reliability]

  Duration of study completion for each site, estimated 3-5 weeks

• Incidence of injury to Physical Therapist (PT) caused by device [PT safety]

  Duration of study completion for each site, estimated 3-5 weeks

• Device, Effectiveness

  Duration of study participation for each subject, estimated 3-5 weeks

Other Outcomes (3)

• 30-Second Chair Stand Test

  Duration of study completion for each site, estimated 3-5 weeks

• Timed Stair Test

  Duration of study completion for each site, estimated 3-5 weeks

• Patient and Clinician Reported Outcomes (surveys)

  Duration of study completion for each site, estimated 3-5 weeks

Study Arms (1)

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.

Device: Keeogo™ Dermoskeleton

Interventions

Keeogo™ Dermoskeleton 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.

Keeogo™ Dermoskeleton

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• B-Temia, Inc.: lead

Study Sites (4)

Shirley Ryan Ability Lab (SRA)

Chicago, Illinois, 60611, United States

Location

Human Performance and Engineering Research (HPER)

West Orange, New Jersey, 07052, United States

Location

James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury

The Bronx, New York, 10468, United States

Location

Assistive Technology Clinic (ATC)

Toronto, Ontario, M6A 2E1, Canada

Location

Related Publications (5)

• 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.

  PMID: 26289955 BACKGROUND

• 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.

  PMID: 30248015 BACKGROUND

• 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.

  PMID: 28533700 BACKGROUND

• 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.

  PMID: 29183379 BACKGROUND

• 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.

  PMID: 23850614 BACKGROUND

Related Links

• Disability and Functioning (Noninstitutionalized Adults Aged 18 and Over)
• Mapping Connections. An Understanding of Neurological Conditions in Canada. The National Population Health Study of Neurological Conditions.: Neurological Health Charities Canada. Government of Canada. Canadian Institutes of Health Research.
• Canada S. Canada at a Glance 2018. Population
• Medical Devices; Physical Medicine Devices; Classification of the Powered Exoskeleton A Rule by the Food and Drug Administration on 02/24/2015
• (CDC) CfDCaP. National Center for Health Statistics - Cerebrovascular Disease or Stroke

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arun Jayaraman, PT, PhD.

  Shirley Ryan Ability Lab (SRA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Sites will enroll participants in order of recruitment. No other randomization procedure will be applied.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 14, 2019
• Study Start: July 22, 2019
• Primary Completion: March 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 29, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); CA (1)