Clinical trial NCT05197127: Efficacy of Samsung GEMS-H Device Training in Older Adults
Official title: Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Geriatrics
Keywords: Geriatrics
Gait Training
Exoskeleton
Fall Risk
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2022-01-19
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in 10 Meter Walk Test Speed
timeFrame: 0 weeks and through study completion (average of 4-6 weeks)
measure: Change in 6 minute walk test distance
timeFrame: 0 weeks and through study completion (average of 4-6 weeks)
measure: Change in Berg Balance Scale Score
timeFrame: 0 weeks and through study completion (average of 4-6 weeks)
measure: Change in Functional Gait Assessment Score
timeFrame: 0 weeks and through study completion (average of 4-6 weeks)
measure: Change in 5 Times Sit-to-Stand Time
timeFrame: 0 weeks and through study completion (average of 4-6 weeks)
Secondary outcomes:
measure: Change in Sedentary Bouts per day
timeFrame: 0 weeks and through study completion (average of 4-6 weeks)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Arun Jayaraman, PT, PHD
role: PRINCIPAL_INVESTIGATOR
References: