Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
NCT Number: NCT05197127
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.
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Notify Me65 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60611, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 0 weeks and through study completion (average of 4-6 weeks)
distance in meters covered in six minutes
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Shirley Ryan AbilityLab
Other
Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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