Efficacy of Samsung GEMS-H Device Training in Older Adults

Shirley Ryan AbilityLab

Status: Completed

Conditions: Geriatrics

Treatments: Device: exoskeleton-based gait training

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05197127

Hip Exoskeleton Older Adult

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Device Walking Group

Experimental group

Description:

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.

Treatment:

Device: exoskeleton-based gait training