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OpenTrials
Completed

NCT Number: NCT05197127

Efficacy of Samsung GEMS-H Device Training in Older Adults

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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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in 10 Meter Walk Test Speed

    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

  2. Change in 6 minute walk test distance

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

    distance in meters covered in six minutes

  3. Change in Berg Balance Scale Score

    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)

  4. Change in Functional Gait Assessment Score

    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)

  5. Change in 5 Times Sit-to-Stand Time

    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

Secondary outcomes

  1. Change in Sedentary Bouts per day

    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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Collaborators

  • Samsung Electronics

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 19, 2022
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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