Efficacy of Samsung GEMS-H Device Training in Older Adults

Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty

The purpose of this study is to evaluate the feasibility of using Samsung robotic hip assist-based mobility intervention for older adults with frailty.

The specific aims of this project are:

Aim 1 Will investigate the feasibility of the Samsung robotic hip assist-based mobility intervention on gait function, sedentary time, and fall risk.

Hypothesis: A 6-week robotic device-based mobility intervention will improve locomotor gait function, sedentary time, and fall risk.

Study Overview

• Status: Completed
• Conditions: Geriatrics
• Intervention / Treatment: Device: exoskeleton-based gait training

Detailed Description

Twelve individuals above the age of 65 years old were recruited to participate in twelve sessions that occurred 2-3 times per week over a 4-6 week period using the GEMS-H. In addition to selecting individuals over the age of 65, qualifying participants also had to be able to walk with or without an assistive device for greater than ten feet. Medical clearance was obtained from each participant's primary physician prior to training with the device.

Gait training included dynamic over-ground walking (both self-selected and fast-paced), variable conditions of multidirectional walking, and training on ramps, stairs, and obstacle negotiation. All training was done under the supervision of a trained physical therapist. The amount of assistance and resistance torque provided by the hip motors of the GEMS-H was personalized according to each participant's specific abilities and self-reported tolerance/comfort throughout each session. These modifications followed a training progression model of increasing resistance and decreasing assistance over the course of the twelve sessions to maximize the challenge and improve strength and endurance in each participant.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Shirley Ryan AbilityLab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• They are primarily English speaking
• > 65 years of age
• Able to walk with or without an assistive device >10 feet
• Able to obtain medical clearance from the participant's primary physician
• We will not include any special populations in this study

Exclusion Criteria:

• Cannot comprehend or provide inform consent
• Unable to fit the device within the hip frame size of310mm-380mm (approximately 12-15 inches)
• Other weight and length limitations that restrict the proper fit of the device
• Any significant neurological diagnosis impacting safe use of the device

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Device Walking Group; Twelve participants over 65 years old completed a total of twelve 30-minute gait training sessions over a period of 4-6 weeks using the GEMS-H. All gait training sessions were completed in the community spaces at a senior living community. Gait training included dynamic over-ground walking (both self-selected and fast-paced),variable conditions of multi-directional walking, and training on ramps, stairs, and obstacle negotiation.

Device: exoskeleton-based gait training; Gait training included dynamic over-ground walking (both self-selected and fast-paced), variable conditions of multi-directional walking, and training on ramps, stairs, and obstacle negotiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10 Meter Walk Test Speed	Average walking speed measured over 10 meters, tested at self selected velocity and fast velocity	0 weeks and through study completion (average of 4-6 weeks)
Change in 6 minute walk test distance	distance in meters covered in six minutes	0 weeks and through study completion (average of 4-6 weeks)
Change in Berg Balance Scale Score	Total score across 14 items in the Berg Balance Scale, scored 0-56 (maximum score is 56)	0 weeks and through study completion (average of 4-6 weeks)
Change in Functional Gait Assessment Score	Total score across 10 items in the Functional Gait Assessment, scored 0-30 (maximum score is 30)	0 weeks and through study completion (average of 4-6 weeks)
Change in 5 Times Sit-to-Stand Time	The time required to stand up and sit down from a chair five times without assistance	0 weeks and through study completion (average of 4-6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Sedentary Bouts per day	Using a wearable sensor, we measured the number of sedentary bouts greater than 3 minutes per day	0 weeks and through study completion (average of 4-6 weeks)

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Collaborators: Samsung Electronics

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): May 7, 2019
• Study Completion (Actual): May 7, 2019

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Exoskeleton; Geriatrics; Gait Training; Fall Risk
• Other Study ID Numbers: Hip Exoskeleton Older Adult

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No