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

Stroke Clinical Trial

Official title:

Safety and Efficacy on Functional Mobility Following Samsung GEMS-H Device Training in Sub-Acute and Chronic Stroke: A Pivotal Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285060
• Other study ID #: 00210372
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2020
• Est. completion date: December 2021

Study information

• Verified date: September 2021
• Source: Samsung Electronics
• Contact: Arun Jayaraman, Ph.D.
• Phone: +1-312-238-6875
• Email: ajayaraman[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Device:
• Samsung GEMS-H
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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Electronics	Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of device malfunctions	Device reliability will be assessed by the number of device malfunctions throughout the duration of the study	Duration of study (estimated 12 months)
Other	ActiGraph activity monitor	Changes in average daily step count	Duration of study participation (estimated 4 months)
Other	Transcranial Magnetic Stimulation (TMS)	Measure changes in descending corticospinal drive to the lower limb muscles	Baseline, Post-Intervention (estimated 8 weeks)
Other	10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)	Changes in self-selected walking speed measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Other	10 Meter Walk Test (Fastest walking speed) (10MWT-FS)	Changes in fastest walking speed measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	10 Meter Walk Test (Self-selected walking speed) (10MWT-SS) with the device	Changes in self-selected walking speeds between two conditions (with and without the device)	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	10 Meter Walk Test (Fastest walking speed) (10MWT-FS) with the device	Changes in fastest walking speeds between two conditions (with and without the device)	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	6 Minute Walk Test (6MWT)	Changes in walking endurance measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Other	6 Minute Walk Test (6MWT) with the device	Changes in walking endurance between two conditions (with and without the device)	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Berg Balance Scale (BBS)	Changes in functional balance measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Functional Gait Assessment (FGA)	Change in functional balance measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), 1 month Post-Intervention (1 month follow-up)
Other	5 Times Sit to Stand Test (5xSST)	Change in lower extremity strength measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Gait analysis using a gait mat	Changes in spatiotemporal parameters measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA)	Changes in motor recovery measured without the device	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Manual Muscle Testing (MMT)	Changes in leg strength measured without the device	Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Modified Ashworth Test (MAS)	Changes in leg spasticity measured without the device	Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Passive Range of Motion (PROM)	Changes in passive range of motion in leg joints measured without the device	Baseline, Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Modified Falls Efficacy Scale (mFES)	Changes in perception of balance and stability	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Activities-specific and Balance Confidence Scale (ABC)	Changes in confidence in performing various ambulatory activities without falling	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Stoke Impact Scale (SIS)	Changes in the measure of the impact of stroke on overall physical and cognitive function	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Patient Health Questionnaire-9 (PHQ-9)	Changes in depression	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Stroke Specific Quality of Life (SSQoL)	Changes in the health-related quality of life	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Other	Oxygen Consumption using Cosmed K4b2	Changes in metabolic energy expenditure	Baseline, Mid-Intervention (estimated 4 weeks), Post-Intervention (estimated 8 weeks), 1 month Post-Intervention (1 month follow-up)
Primary	Incidence of device related adverse events	Safety will be assessed by the number of device related adverse events throughout the duration of the study	Duration of study participation (estimated 6 months)
Primary	10 Meter Walk Test (Self-selected walking speed) (10MWT-SS)	Change in self-selected walking speed measured without the device	Baseline, Post-Intervention (estimated 8 weeks)
Secondary	6 Minute Walk Test (6MWT)	Change in walking endurance measured without the device	Baseline, Post-Intervention (estimated 8 weeks)
Secondary	Berg Balance Scale (BBS)	Changes in functional balance measured without the device	Baseline, Post-Intervention (estimated 8 weeks)
Secondary	Functional Gait Assessment (FGA)	Change in functional balance measured without the device	Baseline, Post-Intervention (estimated 8 weeks)