Lower Limb InjuryNCT03924765
Assistive Hip Exoskeleton Study for Stroke
A study testing Powered hip exoskeleton in people with Lower Limb Injury and Stroke, 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 with stroke to increase their community mobility, independence, and health. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lower Limb Injury, Stroke
- 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
- 24 Jul 2019to 19 Nov 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-85 years
- Had stroke over 6 months prior
- Greater than 17 on minimental state examination (MMSE)
- Sit unsupported for a minimum of 30 seconds
- Follow a 3 step command.
- Ability to walk without support (a rail as needed is allowed), with a walking speed of at least 0.4 m/s (limited community ambulatory speed)
Show all 10Show fewer
- Ability to walk for at least 6 minutes
- Willingness and ability to participate over a 1-4 hour experiment, with breaks enforced regularly and as needed
- Ability to transfer (sit-to-stand and stand-to-sit) with no external support (arm rests support allowed)
- Ability to ambulate over small slopes (3 degrees) and a few steps (6 steps)
Who cannot join
- Loss of sensation in the legs
- A complete spinal cord injury
- History of concussion in the last 6 months
- History of any severe cardiovascular conditions
- Severe arthritis
- Orthopedic problems that limit lower extremity passive range of motion (knee flexion contracture of >10 degrees, knee flexion active ROM 15 degrees)
Show all 16Show fewer
- Pre-existing neurological and other disorders such as Parkinson's disease, ALS, MS, dementia
- History of head trauma
- Lower extremity amputation
- Non-healing ulcers of a lower extremity
- Renal dialysis or end state liver disease
- Legal blindness or severe visual impairment
- Uses a pacemaker
- Has a metal implants in the head region
- Uses medications that lower seizure thresholds.
- Lastly, if the subject is participating in another clinical trial and/or subject's condition relating to criteria that, in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results, subject will be excluded from the study.
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: Improving Community Ambulation for Stroke Survivors Using Powered Hip Exoskeletons With Adaptive Environmental Controllers
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 with stroke 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 stroke 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 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 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 team has previously designed and extensively tested an autonomous hip exoskeleton in able-bodied subjects on a treadmill and plan to follow this up with a separate study on able bodied subjects during overground locomotion of walking, stairs, and ramps. The aim of this study is to translate an autonomous robotic hip exoskeleton to provide adaptive assistance in community ambulation for stroke survivors with mobility impairment. The team will analyze the biomechanical effects and clinical benefits with using an autonomous hip exoskeleton for a walking impaired user (due to stroke). The primary hypothesis for this aim is that stroke survivors will increase their mobility in community ambulation tasks using the adaptive control framework. A sub-hypothesis is that stroke survivors who present with unilateral impairment will have superior biomechanical and clinical outcomes using a controller with asymmetric assistance. The investigators expect a controller that provides a greater assistance to the impaired side to improve overall symmetry and help the stroke survivor maintain a more efficient gait pattern to help improve walking speed (primary outcome measure). 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. This aim will have a positive impact by helping to inform the design and control of future exoskeleton for assisting individuals with lower limb disabilities, with specific insight in stroke survivors with mobility impairment.
- Conditions
- Lower Limb Injury, Stroke
- Being tested
- Powered hip exoskeleton
- Keywords
- Exoskeleton
- Medical subject headings
- Leg Injuries, Stroke
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 be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors.
| Study group | Role | What they receive |
|---|---|---|
| Individuals post-stroke using a powered hip exoskeleton | Experimental | This study will be conducted on a sample population of stroke 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.
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance
Using five different hip exoskeleton assistance strategies, the participant's overground self-selected walking speed was recorded. Assistance types are 1) Unilateral Paretic Assistance, 2) Unilateral Non-Paretic Assistance, 3) Bilateral Equal Assistance, 4) Bilateral Additional Paretic Assistance, and 5) Bilateral Additional Non-Paretic Assistance. The first information (unilateral or bilateral) refers to the leg(s) that the exoskeleton is providing assistance with. For example, unilateral assistance means that the assistance is provided to only one side (zero assistance for the other side). The second information (additional paretic/non-paretic or equal) refers to the leg that the assistance is provided more. For example, bilateral additional paretic assistance means that the exoskeleton is providing assistance to both hip joints but provides higher magnitude on the paretic side.
Measured: 4 hours
Secondary outcomes (1)
Step Length Asymmetry Using Hip Exoskeleton Assistance
Step length asymmetry was calculated by dividing the paretic side step length by the sum of the paretic and non-paretic side step lengths, where an asymmetry of 0.5 indicates perfect symmetry between the paretic and non-paretic sides. Using five different hip exoskeleton assistance strategies, the participant's Step Length Asymmetry during overground walking was recorded. Assistance types are 1) Unilateral Paretic Assistance, 2) Unilateral Non-Paretic Assistance, 3) Bilateral Equal Assistance, 4) Bilateral Additional Paretic Assistance, and 5) Bilateral Additional Non-Paretic Assistance. The first information (unilateral or bilateral) refers to the leg(s) that the exoskeleton is providing assistance with. For example, unilateral assistance means that the assistance is provided to only one side (zero assistance for the other side). The second information (additional paretic/non-paretic or equal) refers to the leg that the assistance is provided more.
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 start24 Jul 2019
- Primary completion19 Nov 2020
- Study completion19 Nov 2020
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 Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03924765
- Sponsor's protocol ID
- H19179
- Status last verified
- Oct 2021
- First submitted
- 19 Apr 2019
- Last updated
- 15 Dec 2021
- 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 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Community Ambulation for Stroke Survivors Using Powered Hip Exoskeletons With Adaptive Environmental Controllers
- ClinicalTrials.gov ID
- NCT03924765
- Acronym / sponsor ID
- H19179
- Conditions
- Lower Limb Injury, Stroke
- Keywords
- Exoskeleton
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Study start
- 24 Jul 2019 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 23 Apr 2019 (actual)
- Results
- Posted 15 Dec 2021
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 with stroke 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 stroke 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 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 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 team has previously designed and extensively tested an autonomous hip exoskeleton in able-bodied subjects on a treadmill and plan to follow this up with a separate study on able bodied subjects during overground locomotion of walking, stairs, and ramps. The aim of this study is to translate an autonomous robotic hip exoskeleton to provide adaptive assistance in community ambulation for stroke survivors with mobility impairment. The team will analyze the biomechanical effects and clinical benefits with using an autonomous hip exoskeleton for a walking impaired user (due to stroke). The primary hypothesis for this aim is that stroke survivors will increase their mobility in community ambulation tasks using the adaptive control framework. A sub-hypothesis is that stroke survivors who present with unilateral impairment will have superior biomechanical and clinical outcomes using a controller with asymmetric assistance. The investigators expect a controller that provides a greater assistance to the impaired side to improve overall symmetry and help the stroke survivor maintain a more efficient gait pattern to help improve walking speed (primary outcome measure). 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. This aim will have a positive impact by helping to inform the design and control of future exoskeleton for assisting individuals with lower limb disabilities, with specific insight in stroke survivors with mobility impairment.
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 |
|---|---|---|
| Individuals post-stroke using a powered hip exoskeleton | Experimental | Device: Powered hip exoskeletonThis study will be conducted on a sample population of stroke 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 18-85 years
- Had stroke over 6 months prior
- Greater than 17 on minimental state examination (MMSE)
- Sit unsupported for a minimum of 30 seconds
- Follow a 3 step command.
Key exclusion criteria (16 listed)
- Loss of sensation in the legs
- A complete spinal cord injury
- History of concussion in the last 6 months
- History of any severe cardiovascular conditions
- Severe arthritis
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 be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors. | Device | Individuals post-stroke using a powered hip exoskeleton |
Primary outcome
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance
Time frame: 4 hours
Using five different hip exoskeleton assistance strategies, the participant's overground self-selected walking speed was recorded. Assistance types are 1) Unilateral Paretic Assistance, 2) Unilateral Non-Paretic Assistance, 3) Bilateral Equal Assistance, 4) Bilateral Additional Paretic Assistance, and 5) Bilateral Additional Non-Paretic Assistance. The first information (unilateral or bilateral) refers to the leg(s) that the exoskeleton is providing assistance with. For example, unilateral assistance means that the assistance is provided to only one side (zero assistance for the other side). The second information (additional paretic/non-paretic or equal) refers to the leg that the assistance is provided more. For example, bilateral additional paretic assistance means that the exoskeleton is providing assistance to both hip joints but provides higher magnitude on the paretic side.
1 secondary outcome
Step Length Asymmetry Using Hip Exoskeleton Assistance
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- 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 Institute of Technology
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 and Stroke, 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 10 inclusion and 16 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 15 Dec 2021. 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 15 Dec 2021). 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?
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance (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 15 Dec 2021; AzTrials last refreshed its copy on 28 Oct 2026.