Lower Limb InjuryNCT03924752
Powered Hip Exoskeleton Assistance Study
A study testing Powered hip exoskeleton in people with Lower Limb Injury, run by Georgia Institute of Technology at 1 site in United States.
Trial summary
The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals who have walking impairments due to disease to increase their community mobility… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Lower Limb Injury
- What is being tested?
- Powered hip exoskeleton
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2021to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 18-85 years of age
- Subjects should be capable of walking, ascending/descending stairs and ramps with full capability in lower extremity passive range of motion (knee flexion contracture of >10 degrees, knee flexion ROM < 90 degrees, hip flexion contracture < 25 degrees, and ankle plantar flexion contracture of >15 degrees).
- Subjects must be able to walk for at least 5 minutes and willing and able to participate over a 1-6 hours experiment with breaks and rest enforced regularly and as needed.
- Subjects must be able to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests OK) and to ambulate over small slopes (3 degrees) and a few steps (6 steps).
Who cannot join
- History of neurological injury, gait pathology, or cardiovascular condition that would limit your ability to ambulate for multiple hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Exoskeleton and Prosthetic Intelligent Controls Lab
Atlanta, Georgia, 30332
About this study
Official title: Development of a Powered Exoskeleton Device for Lower Limb Assistance
The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals who have walking impairments due to disease to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.
Read the detailed description
One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. The study is interested in exploring the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, this work will be able to provide the biggest benefit to patients and advance the state-of-the-art with assistive hip exoskeletons. A large patient population that could benefit from lower limb assistive technology are stroke survivors, which is the specific population this proposal targets. One common characteristic of stroke survivors who regain their ability to walk is that the hip muscles are overtaxed due to distal weakness. The investigators propose to use a powered hip exoskeleton to augment their proximal musculature, which needs to produce significant power output in most locomotion activities such as standing up, walking, and going up stairs or slopes. Another biomechanical aspect of stroke survivors is an asymmetric gait in terms of kinematics, kinetics and muscle activations. The research team will examine what kind of exoskeleton assistance is most beneficial to stroke survivors for enhancing community ambulation. The hypothesis is that since the gait is asymmetric, the controller will need to be asymmetric to provide optimal assistance to aid in mobility. The group's long-term research goal is to create powered assistive exoskeletons devices that are of great value to individuals with serious lower limb disabilities by improving clinical outcomes such as walking speed and community ambulation ability. The overall objective of the proposed project is to study the biomechanical effects of using a hip exoskeleton with adaptive controllers for assisting stroke survivors with lower limb deficits to improve their community ambulation capabilities. The central hypothesis overarching both aims is that exoskeleton control that adapts to environmental terrain will improve mobility metrics for human exoskeleton users on community ambulation tasks. The rationale is that since human biomechanics change based on task, exoskeleton controllers likewise need to optimize their assistance levels to match what the human is doing. The first aim of the proposed study is to determine the benefit of exoskeleton control that adapts to the environment for improving community ambulation capability. The team has previously designed and extensively tested an autonomous hip exoskeleton in able-bodied subjects on a treadmill. The investigators plan to extend their control framework to over ground walking and tune assistance magnitude and timing levels to enable efficient locomotion over stairs and ramps on their novel terrain park. The investigators plan to compare a controller that adapts its assistance strategy based on locomotion task to a static controller as well as not wearing the exoskeleton. The primary hypothesis for this aim is that exoskeleton control that adapts to environmental terrain will improve mobility metrics such as task completion speed for human exoskeleton users on community ambulation tasks. The expected outcome of these aims will be an increased understanding of the biomechanical and clinical effects in applying hip assistance with a robotic exoskeleton in community ambulation tasks such as overground walking, ramps and stairs. This work will serve as a foundational start for a broader planned study of optimizing controllers to improve biomechanics in the walking impaired using powered hip autonomous exoskeletons.
- Conditions
- Lower Limb Injury
- Being tested
- Powered hip exoskeleton
- Keywords
- Exoskeleton
- Medical subject headings
- Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered hip exoskeletonDevice
The study team will test a powered hip exoskeleton and its capability to improve locomotion.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals using powered exoskeleton | Experimental | This study will be conducted on a sample population of able-bodied subjects (single arm). Each subject will test with each condition of the exoskeleton (repeated measures). Receives: Device: Powered hip exoskeleton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes
Measure Description: The subject's preferred overground walking speed while wearing a powered hip exoskeleton was recorded. During walking, the exoskeleton provided hip assistance. There was a total of five walking conditions that were evaluated: 1) level-ground, 2) ramp ascent, 3) ramp descent, 4) stair ascent and 5) stair descent. The ramp incline was set to 9.2 degrees and the stair height was set to 15.24 cm. The user's preferred walking speed was calculated by looking at the distance traveled divided by time for a given walking condition. The distance was fixed and a completion time for each trial was recorded with a computer timer to calculate the average walking velocity for a given trial.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2019
- Study start13 Feb 2021
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Limb InjuryStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The model used is a repeated measures single arm study. Multiple conditions including using and not using the device will be tested on the same subjects to have multiple test points on a per subject basis.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aaron Young, Ph.D., Principal investigator, Georgia Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924752
- Sponsor's protocol ID
- H19178
- Status last verified
- Jan 2022
- First submitted
- 19 Apr 2019
- Last updated
- 8 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Powered Exoskeleton Device for Lower Limb Assistance
- ClinicalTrials.gov ID
- NCT03924752
- Acronym / sponsor ID
- H19178
- Conditions
- Lower Limb Injury
- Keywords
- Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Study start
- 13 Feb 2021 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 8 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The increased metabolic and biomechanical demands of ambulation limit community mobility in persons with lower limb disability due to neurological damage. There is a critical need for improving the locomotion capabilities of individuals who have walking impairments due to disease to increase their community mobility, independence, and health. Robotic exoskeletons have the potential to assist these individuals by increasing community mobility to improve quality of life. While these devices have incredible potential, current technology does not support dynamic movements common with locomotion such as transitioning between different gaits and supporting a wide variety of walking speeds. One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. This research is interested in studying the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, the biggest benefit to patient populations will be achieved to help advance the state-of-the-art with assistive hip exoskeletons.
Detailed description
One significant challenge in achieving community ambulation with exoskeletons is providing an adaptive control system to accomplish a wide variety of locomotor tasks. Many exoskeletons today are developed without a detailed understanding of the effect of the device on the human musculoskeletal system. The study is interested in exploring the question of how the control system affects human biomechanics including kinematic, kinetics and muscle activation patterns. By optimizing exoskeleton controllers based on human biomechanics and adapting control based on task, this work will be able to provide the biggest benefit to patients and advance the state-of-the-art with assistive hip exoskeletons. A large patient population that could benefit from lower limb assistive technology are stroke survivors, which is the specific population this proposal targets. One common characteristic of stroke survivors who regain their ability to walk is that the hip muscles are overtaxed due to distal weakness. The investigators propose to use a powered hip exoskeleton to augment their proximal musculature, which needs to produce significant power output in most locomotion activities such as standing up, walking, and going up stairs or slopes. Another biomechanical aspect of stroke survivors is an asymmetric gait in terms of kinematics, kinetics and muscle activations. The research team will examine what kind of exoskeleton assistance is most beneficial to stroke survivors for enhancing community ambulation. The hypothesis is that since the gait is asymmetric, the controller will need to be asymmetric to provide optimal assistance to aid in mobility. The group's long-term research goal is to create powered assistive exoskeletons devices that are of great value to individuals with serious lower limb disabilities by improving clinical outcomes such as walking speed and community ambulation ability. The overall objective of the proposed project is to study the biomechanical effects of using a hip exoskeleton with adaptive controllers for assisting stroke survivors with lower limb deficits to improve their community ambulation capabilities. The central hypothesis overarching both aims is that exoskeleton control that adapts to environmental terrain will improve mobility metrics for human exoskeleton users on community ambulation tasks. The rationale is that since human biomechanics change based on task, exoskeleton controllers likewise need to optimize their assistance levels to match what the human is doing. The first aim of the proposed study is to determine the benefit of exoskeleton control that adapts to the environment for improving community ambulation capability. The team has previously designed and extensively tested an autonomous hip exoskeleton in able-bodied subjects on a treadmill. The investigators plan to extend their control framework to over ground walking and tune assistance magnitude and timing levels to enable efficient locomotion over stairs and ramps on their novel terrain park. The investigators plan to compare a controller that adapts its assistance strategy based on locomotion task to a static controller as well as not wearing the exoskeleton. The primary hypothesis for this aim is that exoskeleton control that adapts to environmental terrain will improve mobility metrics such as task completion speed for human exoskeleton users on community ambulation tasks. The expected outcome of these aims will be an increased understanding of the biomechanical and clinical effects in applying hip assistance with a robotic exoskeleton in community ambulation tasks such as overground walking, ramps and stairs. This work will serve as a foundational start for a broader planned study of optimizing controllers to improve biomechanics in the walking impaired using powered hip autonomous exoskeletons.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The model used is a repeated measures single arm study. Multiple conditions including using and not using the device will be tested on the same subjects to have multiple test points on a per subject basis.
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals using powered exoskeleton | Experimental | Device: Powered hip exoskeletonThis study will be conducted on a sample population of able-bodied subjects (single arm). Each subject will test with each condition of the exoskeleton (repeated measures). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Between 18-85 years of age
- Subjects should be capable of walking, ascending/descending stairs and ramps with full capability in lower extremity passive range of motion (knee flexion contracture of >10 degrees, knee flexion ROM < 90 degrees, hip flexion contracture < 25 degrees, and ankle plantar flexion contracture of >15 degrees).
- Subjects must be able to walk for at least 5 minutes and willing and able to participate over a 1-6 hours experiment with breaks and rest enforced regularly and as needed.
- Subjects must be able to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests OK) and to ambulate over small slopes (3 degrees) and a few steps (6 steps).
Key exclusion criteria (1 listed)
- History of neurological injury, gait pathology, or cardiovascular condition that would limit your ability to ambulate for multiple hours.
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 |
|---|---|---|
| Powered hip exoskeletonThe study team will test a powered hip exoskeleton and its capability to improve locomotion. | Device | Healthy individuals using powered exoskeleton |
Primary outcome
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes
Time frame: 4 hours
Measure Description: The subject's preferred overground walking speed while wearing a powered hip exoskeleton was recorded. During walking, the exoskeleton provided hip assistance. There was a total of five walking conditions that were evaluated: 1) level-ground, 2) ramp ascent, 3) ramp descent, 4) stair ascent and 5) stair descent. The ramp incline was set to 9.2 degrees and the stair height was set to 15.24 cm. The user's preferred walking speed was calculated by looking at the distance traveled divided by time for a given walking condition. The distance was fixed and a completion time for each trial was recorded with a computer timer to calculate the average walking velocity for a given trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Aaron Young, Ph.D. principal investigator
Georgia Tech
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered hip exoskeleton in people with Lower Limb Injury, run by Georgia Institute of Technology 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 4 inclusion and 1 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 8 Feb 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?
Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-Selected Walking Speed Using Hip Exoskeleton Assistance Across Different Locomotion Modes (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Feb 2022; AzTrials last refreshed its copy on 27 Oct 2026.