Clinical trial NCT03986320: Evaluation of the Effectiveness and Safety of Keeogo™ Dermoskeleton in Subjects With Mobility Impairments Due to Stroke
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Stroke
Hemiparesis
Cerebral Vascular Accident
Keywords: Keeogo™
Dermoskeleton
Powered dermoskeleton
Lower limb dermoskeleton
Assistive exoskeleton
Orthotic dermoskeleton
Lead sponsor: B-Temia, Inc.
Sponsor class: INDUSTRY
First posted: 2019-06-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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;

Primary outcomes:
measure: Incidence of device-related adverse events [Safety]
timeFrame: Duration of study participation for each subject, estimated 3-5 weeks
Secondary outcomes:
measure: Incidence of device malfunctions during study procedures [Device Reliability]
timeFrame: Duration of study completion for each site, estimated 3-5 weeks
measure: Incidence of injury to Physical Therapist (PT) caused by device [PT safety]
timeFrame: Duration of study completion for each site, estimated 3-5 weeks
measure: Device, Effectiveness
timeFrame: Duration of study participation for each subject, estimated 3-5 weeks
Other outcomes:
measure: 30-Second Chair Stand Test
timeFrame: Duration of study completion for each site, estimated 3-5 weeks
measure: Timed Stair Test
timeFrame: Duration of study completion for each site, estimated 3-5 weeks
measure: Patient and Clinician Reported Outcomes (surveys)
timeFrame: Duration of study completion for each site, estimated 3-5 weeks
Locations:
city: Chicago
country: United States
facility: Shirley Ryan Ability Lab (SRA)
state: Illinois
city: West Orange
country: United States
facility: Human Performance and Engineering Research (HPER)
state: New Jersey
city: Bronx
country: United States
facility: James J Peters VA Medical Center - Center for the Medical Consequences of Spinal Cord Injury
state: New York
city: Toronto
country: Canada
facility: Assistive Technology Clinic (ATC)
state: Ontario
Study officials:
affiliation: Shirley Ryan Ability Lab (SRA)
name: Arun Jayaraman, PT, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.