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Efficacy of Samsung GEMS-H Device Training in Older Adults

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05197127
Enrollment
12
Registered
2022-01-19
Start date
2018-09-14
Completion date
2019-05-07
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatrics

Keywords

Geriatrics, Gait Training, Exoskeleton, Fall Risk

Brief summary

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.

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.

Interventions

DEVICEexoskeleton-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.

Sponsors

Samsung Electronics
CollaboratorINDUSTRY
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in 10 Meter Walk Test Speed0 weeks and through study completion (average of 4-6 weeks)Average walking speed measured over 10 meters, tested at self selected velocity and fast velocity
Change in 6 minute walk test distance0 weeks and through study completion (average of 4-6 weeks)distance in meters covered in six minutes
Change in Berg Balance Scale Score0 weeks and through study completion (average of 4-6 weeks)Total score across 14 items in the Berg Balance Scale, scored 0-56 (maximum score is 56)
Change in Functional Gait Assessment Score0 weeks and through study completion (average of 4-6 weeks)Total score across 10 items in the Functional Gait Assessment, scored 0-30 (maximum score is 30)
Change in 5 Times Sit-to-Stand Time0 weeks and through study completion (average of 4-6 weeks)The time required to stand up and sit down from a chair five times without assistance

Secondary

MeasureTime frameDescription
Change in Sedentary Bouts per day0 weeks and through study completion (average of 4-6 weeks)Using a wearable sensor, we measured the number of sedentary bouts greater than 3 minutes per day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026