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Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke

Primary Purpose

Stroke, Chronic Stroke

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Samsung GEMS-H
Sponsored by
Samsung Electronics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stroke focused on measuring Stroke, Exoskeleton

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ≥ 30-days post stroke
  • Age: 18-85 Years
  • Initial gait speed of ≥ 0.4 m/s and ≤ 0.8 m/s
  • Adequate cognitive function (MMSE score >17)
  • Ability to walk at least 10m with maximum 1 person assist
  • Physician approval for patient participation
  • Able to safely fit into device specifications and tolerate minimum assistance

Exclusion Criteria:

  • ≤90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement)
  • ≤ 6 months post coronary artery bypass graft (CABG) or cardiac valve procedure
  • Severe osteoporosis as indicated by physician medical clearance
  • Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
  • Pregnancy
  • Uncontrolled hypertension
  • Lower extremity fracture
  • Modified Ashworth Spasticity ≥3 in hip flexor or extensor
  • Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
  • History of: major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, ongoing active infections, legal blindness, or a history of significant psychiatric illness
  • Participating in any other structured outpatient, home health physical therapy program, or another clinical trial that according to the Principal Investigator is likely to affect study outcome or confound results.

TMS-Specific Exclusion Criteria

  • Pacemakers, metal implants in the head region
  • History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
  • Medications that lower seizure threshold
  • History of concussion in last 6 months

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training Group

Arm Description

All participants are assigned to the training group with the Samsung GEMS-H.

Outcomes

Primary Outcome Measures

Incidence of device related adverse events
Safety will be assessed by the number of device related adverse events throughout the duration of the study
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
Change in self-selected walking speed measured without the device

Secondary Outcome Measures

6 Minute Walk Test (6MWT)
Change in walking endurance measured without the device
Berg Balance Scale (BBS)
Changes in functional balance measured without the device
Functional Gait Assessment (FGA)
Change in functional balance measured without the device

Full Information

First Posted
February 24, 2020
Last Updated
September 24, 2021
Sponsor
Samsung Electronics
Collaborators
Shirley Ryan AbilityLab
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1. Study Identification

Unique Protocol Identification Number
NCT04285060
Brief Title
Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke
Official Title
Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Electronics
Collaborators
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
A single-site, interventional, single-arm trial to evaluate the safety and efficacy on functional mobility following Samsung GEMS-H (Gait Enhancing and Motivating System - Hip) device training in participants with sub-acute and chronic stroke.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Chronic Stroke
Keywords
Stroke, Exoskeleton

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training Group
Arm Type
Experimental
Arm Description
All participants are assigned to the training group with the Samsung GEMS-H.
Intervention Type
Device
Intervention Name(s)
Samsung GEMS-H
Intervention Description
Subjects will participate in 18 sessions of training in the outpatient clinic with a licensed physical therapist. Therapy sessions will include 30 minutes of task specific training and another 15 minutes of the session can be used to focus on patient specific goal areas related to functional mobility and balance. Training sessions will occur 2-3 times a week for 6-8 weeks to complete the training protocol.
Primary Outcome Measure Information:
Title
Incidence of device related adverse events
Description
Safety will be assessed by the number of device related adverse events throughout the duration of the study
Time Frame
Duration of study participation (estimated 6 months)
Title
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
Description
Change in self-selected walking speed measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks)
Secondary Outcome Measure Information:
Title
6 Minute Walk Test (6MWT)
Description
Change in walking endurance measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks)
Title
Berg Balance Scale (BBS)
Description
Changes in functional balance measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks)
Title
Functional Gait Assessment (FGA)
Description
Change in functional balance measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks)
Other Pre-specified Outcome Measures:
Title
Incidence of device malfunctions
Description
Device reliability will be assessed by the number of device malfunctions throughout the duration of the study
Time Frame
Duration of study (estimated 12 months)
Title
ActiGraph activity monitor
Description
Changes in average daily step count
Time Frame
Duration of study participation (estimated 4 months)
Title
Transcranial Magnetic Stimulation (TMS)
Description
Measure changes in descending corticospinal drive to the lower limb muscles
Time Frame
Baseline, Post-Intervention (estimated 8 weeks)
Title
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)
Description
Changes in self-selected walking speed measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Title
10 Meter Walk Test (Fastest walking speed) (10MWT-FS)
Description
Changes in fastest walking speed measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) with the device
Description
Changes in self-selected walking speeds between two conditions (with and without the device)
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
10 Meter Walk Test (Fastest walking speed) (10MWT-FS) with the device
Description
Changes in fastest walking speeds between two conditions (with and without the device)
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
6 Minute Walk Test (6MWT)
Description
Changes in walking endurance measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Title
6 Minute Walk Test (6MWT) with the device
Description
Changes in walking endurance between two conditions (with and without the device)
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Berg Balance Scale (BBS)
Description
Changes in functional balance measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Functional Gait Assessment (FGA)
Description
Change in functional balance measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Title
5 Times Sit to Stand Test (5xSST)
Description
Change in lower extremity strength measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Gait analysis using a gait mat
Description
Changes in spatiotemporal parameters measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)
Description
Changes in motor recovery measured without the device
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Manual Muscle Testing (MMT)
Description
Changes in leg strength measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Modified Ashworth Test (MAS)
Description
Changes in leg spasticity measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Passive Range of Motion (PROM)
Description
Changes in passive range of motion in leg joints measured without the device
Time Frame
Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Modified Falls Efficacy Scale (mFES)
Description
Changes in perception of balance and stability
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Activities-specific and Balance Confidence Scale (ABC)
Description
Changes in confidence in performing various ambulatory activities without falling
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Stoke Impact Scale (SIS)
Description
Changes in the measure of the impact of stroke on overall physical and cognitive function
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
Changes in depression
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Stroke Specific Quality of Life (SSQoL)
Description
Changes in the health-related quality of life
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Title
Oxygen Consumption using Cosmed K4b2
Description
Changes in metabolic energy expenditure
Time Frame
Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 30-days post stroke Age: 18-85 Years Initial gait speed of ≥ 0.4 m/s and ≤ 0.8 m/s Adequate cognitive function (MMSE score >17) Ability to walk at least 10m with maximum 1 person assist Physician approval for patient participation Able to safely fit into device specifications and tolerate minimum assistance Exclusion Criteria: ≤90 days post major orthopedic surgery (i.e. hip, knee, and/or ankle joint replacement) ≤ 6 months post coronary artery bypass graft (CABG) or cardiac valve procedure Severe osteoporosis as indicated by physician medical clearance Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living) Pregnancy Uncontrolled hypertension Lower extremity fracture Modified Ashworth Spasticity ≥3 in hip flexor or extensor Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia History of: major head trauma, lower extremity amputation, non-healing ulcers of a lower extremity, ongoing active infections, legal blindness, or a history of significant psychiatric illness Participating in any other structured outpatient, home health physical therapy program, or another clinical trial that according to the Principal Investigator is likely to affect study outcome or confound results. TMS-Specific Exclusion Criteria Pacemakers, metal implants in the head region History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits Medications that lower seizure threshold History of concussion in last 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Arun Jayaraman, Ph.D.
Phone
+1-312-238-6875
Email
ajayaraman@sralab.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Hohl, DPT
Phone
+1-312-238-2640
Email
khohl@sralab.org
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arun Jayaraman, Ph.D.
Email
ajayaraman@sralab.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Safety and Efficacy of Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke

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