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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Assistive Hip Exoskeleton Study for Stroke

Clinicaltrials.gov identifier NCT03924765

Recruitment Status Recruiting

First Posted April 23, 2019

Last update posted March 17, 2020

Study Description

Brief 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.

  • Condition or Disease:Lower Limb Injury
    Stroke
  • Intervention/Treatment: Device: Powered hip exoskeleton
  • Phase: N/A
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
  • Study Type: Interventional
  • Estimated Enrollment: 5 participants
  • Intervention Model: Single Group Assignment
  • Intervention 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) ()
  • Primary Purpose: Basic Science
  • Official Title: Powered Hip Exoskeleton for Stroke Survivors With Gait Impairment
  • Actual Study Start Date: July 2019
  • Estimated Primary Completion Date: December 2021
  • Estimated Study Completion Date: April 2023
Arms and interventions
Arm Intervention/treatment
Experimental: Healthy individuals using powered 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
The study team will be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors.
Outcome Measures
  • Primary Outcome Measures: 1. Walking Speed [ Time Frame: 18 months ]
    This will include preferred walking speed in the different conditions using the device. Walking speed is calculated by looking at distance traveled divided by time. Distance is typically fixed and a completion time for each trial is recorded with a computer timer to calculate average walking velocity for a given trial.
Eligibility Criteria
  • Ages Eligible for Study: 18 to 85 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

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:

- 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.

Contacts and Locations
Contacts

Contact: Aaron Young, Ph.D. 404-385-5306 aaron.young@me.gatech.edu

Locations

United States, Georgia
Exoskeleton and Prosthetic Intelligent Controls Lab
Atlanta

Sponsors and Collaborators

Georgia Institute of Technology

Investigators

Principal Investigator: Aaron Young, Ph.D. Georgia Institute of Technology

More Information
  • Responsible Party: Georgia Institute of Technology
  • ClinicalTrials.gov Identifier: NCT03924765 History of Changes
  • Other Study ID Numbers: H19179
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: March 17, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Georgia Institute of Technology: Exoskeleton
  • Additional relevant MeSH terms: Stroke Leg Injuries