Efficacy of Samsung GEMS-H Device Training in Older Adults

NCT05197127 | Completed

• 1 other identifier: Hip Exoskeleton Older Adult
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatrics

Keywords

Geriatrics; Gait Training; Exoskeleton; Fall Risk

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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)

• 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 Outcomes (1)

• Change in Sedentary Bouts per day

  0 weeks and through study completion (average of 4-6 weeks)

Study Arms (1)

Device Walking Group

EXPERIMENTAL

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.

Device: exoskeleton-based gait training

Interventions

exoskeleton-based gait training DEVICE

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.

Device Walking Group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Samsung Electronics: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Jayaraman C, Embry KR, Mummidisetty CK, Moon Y, Giffhorn M, Prokup S, Lim B, Lee J, Lee Y, Lee M, Jayaraman A. Modular hip exoskeleton improves walking function and reduces sedentary time in community-dwelling older adults. J Neuroeng Rehabil. 2022 Dec 30;19(1):144. doi: 10.1186/s12984-022-01121-4.

  PMID: 36585676 DERIVED

Study Officials

• Arun Jayaraman, PT, PHD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Max Nader Lab

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 19, 2022
• Study Start: September 14, 2018
• Primary Completion: May 7, 2019
• Study Completion: May 7, 2019
• Last Updated: January 19, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)