Efficacy of Samsung GEMS-H Device Training in Older Adults

Geriatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05197127
• Other study ID #: Hip Exoskeleton Older Adult
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: May 7, 2019

Study information

• Verified date: January 2022
• Source: Shirley Ryan AbilityLab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 7, 2019
• Est. primary completion date: May 7, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Geriatrics

Intervention

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.

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	Samsung Electronics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)