GeriatricsNCT05197127
Efficacy of Samsung GEMS-H Device Training in Older Adults
A study testing exoskeleton-based gait training in people with Geriatrics, run by Shirley Ryan AbilityLab at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Geriatrics
- What is being tested?
- exoskeleton-based gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 7 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty
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.
Read the 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 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.
- Conditions
- Geriatrics
- Being tested
- exoskeleton-based gait training
- Keywords
- Geriatrics, Gait Training, Exoskeleton, Fall Risk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exoskeleton-based gait trainingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: exoskeleton-based gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 10 Meter Walk Test Speed
Average walking speed measured over 10 meters, tested at self selected velocity and fast velocity
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 0 weeks and through study completion (average of 4-6 weeks)
Secondary outcomes (1)
Change in Sedentary Bouts per day
Using a wearable sensor, we measured the number of sedentary bouts greater than 3 minutes per day
Measured: 0 weeks and through study completion (average of 4-6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start14 Sep 2018
- Primary completion7 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GeriatricsStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Arun Jayaraman, PT, PhD, Shirley Ryan AbilityLab
- Investigators
- Arun Jayaraman, PT, PHD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197127
- Sponsor's protocol ID
- Hip Exoskeleton Older Adult
- Status last verified
- Jan 2022
- First submitted
- 17 Dec 2021
- Last updated
- 19 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36585676
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing a Robotic Hip Assist-based Mobility Intervention for Older Adults With Frailty
- ClinicalTrials.gov ID
- NCT05197127
- Acronym / sponsor ID
- Hip Exoskeleton Older Adult
- Conditions
- Geriatrics
- Keywords
- Geriatrics, Gait Training, Exoskeleton, Fall Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 19 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device Walking Group | Experimental | Device: exoskeleton-based gait trainingTwelve 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exoskeleton-based gait trainingGait 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 | Device Walking Group |
Primary outcome
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
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
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)
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)
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
1 secondary outcome
Change in Sedentary Bouts per day
Time frame: 0 weeks and through study completion (average of 4-6 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2022.
- Derived from this study: PubMed 36585676Jayaraman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arun Jayaraman, PT, PHD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exoskeleton-based gait training in people with Geriatrics, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 Meter Walk Test Speed (time frame: 0 weeks and through study completion (average of 4-6 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05197127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2022.