Efficacy of Samsung GEMS-H Device Training in Older Adults

Not Applicable

Completed

• Conditions: Geriatrics
• Interventions: Device: exoskeleton-based gait training

• Registration Number: NCT05197127
• Lead Sponsor: Shirley Ryan AbilityLab

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.

Study Timeline

• Study Start: 2018-09-14
• Primary Completion: 2019-05-07
• Study Completion: 2019-05-07
• Study First Submitted: 2021-12-17
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-04
• Last Update Submitted: 2022-01-04
• Study First Posted: 2022-01-19
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Walking Group	exoskeleton-based gait training	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.

Primary Outcome Measures

Name	Time	Method
Change in 6 minute walk test distance	0 weeks and through study completion (average of 4-6 weeks)	distance in meters covered in six minutes
Change in Berg Balance Scale Score	0 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 10 Meter Walk Test Speed	0 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 Functional Gait Assessment Score	0 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 Time	0 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 Outcome Measures

Name	Time	Method
Change in Sedentary Bouts per day	0 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

Trial Locations

Locations (1)

Shirley Ryan AbilityLab; 🇺🇸 Chicago, Illinois, United States