Ignite Creation Date:
2024-05-06 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 2:22 PM
Study NCT ID:
NCT05197127
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2021-12-17
Brief Title:
Efficacy of Samsung GEMS-H Device Training in Older Adults
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 participants 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 participants specific abilities and self-reported tolerancecomfort 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
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 participants specific abilities and self-reported tolerancecomfort 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None