CClinicalTrials.gg
CompletedNCT03924765Updated Dec 15, 2021Results posted

Assistive Hip Exoskeleton Study for Stroke

An interventional study of Powered hip exoskeleton in Lower Limb Injury and Stroke, sponsored by Georgia Institute of Technology. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-12-15.

Sponsored by Georgia Institute of Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Lower Limb Injury
  • Stroke

Keywords

  • Exoskeleton
03

In context

Stroke

7,287 studies on the registry are indexed under Stroke; 2,006 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 5,370 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Georgia Institute of Technology is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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)
  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Individuals post-stroke using a powered hip exoskeleton

    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).

    Device: Powered hip exoskeleton

Interventions

  • DevicePowered hip exoskeleton

    The study team will be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 4 hours

07

Results

Posted Dec 15, 2021

Participant flow

Participants were recruited based on clinician referral between July 2019 to November 2020. The first participant was enrolled on July 2019 and the last participant was enrolled on November 2020.

Participant flow — Overall Study
MilestoneIndividuals Post-stroke Using a Powered Hip Exoskeleton
Started5
Completed5
Not completed0

Outcome measures

PrimaryOverground 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.

Time frame:
4 hours
Reported as:
Mean · centimeters per second
Overground Self-Selected Walking Speed Using Hip Exoskeleton Assistance
centimeters per secondIndividuals Post-stroke Using a Powered Hip Exoskeleton
Unilateral Paretic Assistance87.03 ± 12.94
Unilateral Non-Paretic Assistance87.96 ± 14.8
Bilateral Equal Assistance90.4 ± 14.2
Bilateral Additional Paretic Assistance93.05 ± 14.64
Bilateral Additional Non-Paretic Assistance94.64 ± 15.69
Statistical analysis
  • Individuals Post-stroke Using a Powered Hip Exoskeleton · ANOVA · p = 0.000005
SecondaryStep 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.

Time frame:
4 hours
Reported as:
Mean · unitless
Step Length Asymmetry Using Hip Exoskeleton Assistance
unitlessIndividuals Post-stroke Using a Powered Hip Exoskeleton
Unilateral Paretic Assistance0.54 ± 0.02
Unilateral Non-Paretic Assistance0.54 ± 0.03
Bilateral Equal Assistance0.54 ± 0.02
Bilateral Additional Paretic Assistance0.54 ± 0.02
Bilateral Additional Non-Paretic Assistance0.53 ± 0.02
Statistical analysis
  • Individuals Post-stroke Using a Powered Hip Exoskeleton · ANOVA · p = 0.131

Adverse events

Collected over Duration of the experiment (4 hours). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Individuals Post-stroke Using a Powered Hip Exoskeleton0/5 (0%)0/5 (0%)0/5 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Individuals Post-stroke Using a Powered Hip Exoskeleton
<=18 years0
Between 18 and 65 years4
>=65 years1
Age, Continuous
Age, Continuous(years)Individuals Post-stroke Using a Powered Hip Exoskeleton
Mean52.4 ± 10.2
Age, Continuous
Age, Continuous(years)Individuals Post-stroke Using a Powered Hip Exoskeleton
Median55 (37 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)Individuals Post-stroke Using a Powered Hip Exoskeleton
Female2
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Individuals Post-stroke Using a Powered Hip Exoskeleton
Hispanic or Latino0
Not Hispanic or Latino5
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Individuals Post-stroke Using a Powered Hip Exoskeleton
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White4
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Individuals Post-stroke Using a Powered Hip Exoskeleton
United States5
Height
Height(Centimeters)Individuals Post-stroke Using a Powered Hip Exoskeleton
Mean172.5 ± 9.8

6 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Exoskeleton and Prosthetic Intelligent Controls Lab
    Atlanta, Georgia 30332, United States
09

References and documents

Study documents

  • Study protocol · Sep 16, 2021
  • Statistical analysis plan · Sep 16, 2021
  • Informed consent form · Mar 26, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03924765
Lead sponsor
Georgia Institute of Technology
Responsible party
Sponsor
First posted
Apr 23, 2019
Start date
Jul 24, 2019
Primary completion
Nov 19, 2020
Completion
Nov 19, 2020
Results posted
Dec 15, 2021
Last update
Dec 15, 2021

Study contacts

Aaron Young, Ph.D.
principal investigator · Georgia Institute of Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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