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OpenTrials
Completed

NCT Number: NCT05536739

Adaptive Hip Exoskeleton for Stroke Gait Enhancement

This work will focus on new algorithms for robotic exoskeletons and testing these in human subject tests. Individuals who have previously had a stroke will walk while wearing a robotic exoskeleton on a specialized treadmill as well as during other movement tasks (e.g. over ground, stairs, ramps). The study will compare the performance of the advanced algorithm with not using the device to determine the clinical benefit.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Exoskeleton and Prosthetic Intelligent Controls Lab

Atlanta, Georgia, 30332, United States

About this study

The focus of this work is a proposed novel artificial intelligence (AI) system to self-adapt control policy in powered exoskeletons to aid deployment systems that personalize to individual patient gait. Individuals post stroke have a broad range of mobility challenges including asymmetric gait, substantially decreased SSWS, and reduced stability, and therefore have greatly impaired overall mobility independence in the community. The investigators expect the proposed novel controller, capable of personalization to such variable and asymmetric gait patterns, will have significant benefits towards increasing community independence and mobility for patients post stroke. Patients post stroke will be fit with a hip exoskeleton (in a powered and/or unpowered state) and proceed to walk on a treadmill or perform various movement tasks. The same tasks will be performed by the patients without wearing the hip exoskeleton to serve as a baseline. The investigators expect improved outcomes in the powered hip exoskeleton compared to the unpowered hip exoskeleton and baseline conditions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Between 18-85 years of age
  • Had a stroke at least 6 months prior to study involvement
  • Are community dwelling, which means the participant does not live in an assisted living facility
  • Are able to provide informed consent to participate in the study activities
  • Can safely participate in the study activities (per self-report)
  • Must have a Functional Ambulation Category (FAC) score of 3 or above, which means the participant can walk without the assistance of another person

Exclusion criteria

  • Require a walker to walk independently
  • Have a shuffling gait pattern overground
  • Have a Functional Ambulation Category (FAC) score of 2 or lower, which means the participant requires the assistance of another person in order to walk
  • Have a significant secondary deficit beyond stroke (e.g. amputation, legal blindness or other severe impairment or condition) that in the opinion of the Principal Investigator (PI), would likely affect the study outcome or confound the results
  • For exoskeleton-only studies, the exoskeleton device does not fit appropriately or safely, as determined by the research team during the fitting assessment.

Treatment and study plan

Hip Exoskeleton

Device

The intervention is an experimental robotic hip exoskeleton in a powered state providing assistance to the user that has been previously developed by the team. It is used to improve walking gait performance.

Baseline

Other

The intervention will serve as a baseline where participants will be asked to perform the tasks without wearing a hip exoskeleton.

Primary outcomes

  1. Temporal Convolutional Network (TCN) Model Performance (Joint Moment Accuracy)

    Time frame: 5 Days

    This outcome represents the error with which the deep learning model embedded into our hip exoskeleton's microprocessor predicts hip joint moments in stroke patients. Specifically, the coefficient of determination (R²) is computed between the predicted hip joint moments and the ground truth measurements. Ground truth measurements are obtained from a laboratory-grade force plate system and inverse dynamics calculations. For these measures, higher R² values (closer to 1.0) indicate better correlation between predicted and actual hip joint moments. This metric provides a comprehensive assessment of the exoskeleton's ability to accurately estimate hip joint moments in stroke patients during tasks, with improved outcomes representing better assistive capabilities for the user.

  2. Metabolic Cost for Level Ground Walking

    Time frame: 5 days

    Metabolic energy expenditure will be quantified using an indirect calorimetry system (Parvo Medics, UT) that measures oxygen consumption (VO₂) and carbon dioxide production (VCO₂) during experimental tasks. Measurements will be collected from each participant during a 5-minute baseline standing period followed by level ground walking trials under three conditions: without the exoskeleton, with the exoskeleton in a powered state, and with the exoskeleton in an unpowered state. Metabolic cost will be calculated from respiratory gas exchange data using standard equations for energy expenditure.

  3. Biological Joint Work - Level Walking

    Time frame: 5 days

    Mechanical work performed by the lower limb joints during level walking will be quantified through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during level walking.

  4. Biological Joint Work - Incline Walking

    Time frame: 5 days

    Mechanical work performed by the lower limb joints will be quantified during incline walking through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the incline walking.

  5. Biological Joint Work - Stair Ascent

    Time frame: 5 days

    Mechanical work performed by the lower limb joints will be quantified during stair ascent through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the stair ascent task.

  6. Biological Joint Work - Sit to Stand

    Time frame: 5 days

    Mechanical work performed by the lower limb joints will be quantified during sit to stand through biomechanical analysis of motion capture data. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the sit to stand task.

  7. Biological Joint Work - go and Grab

    Time frame: 5 days

    Mechanical work performed by the lower limb joints will be quantified during a go and grab task through biomechanical analysis of motion capture data. In the go and grab task, participants take several steps, lean forward, and pick up a weighted object from a low surface just above ground level. Joint moments and angular velocities will be derived through inverse dynamics and kinematics, respectively. Joint power, calculated as the product of joint moment and angular velocity, will be integrated with respect to time using trapezoidal integration to determine mechanical work. Positive work will be calculated by integrating positive joint powers, providing comprehensive quantification of joint energy generation at each joint during the go and grab task.

Secondary outcomes

  1. 10 Meter Walk Test (Self-selected)

    Time frame: 5 days

    This will be measured as the participant walks a distance of 10 meters across a gait mat at their self-selected (or comfortable) walking speed. This measure will be recorded in seconds with lower values indicating faster speed and higher values indicating slower speeds. Self-selected walking speed is highly correlated with functional ability and dependence.

  2. The Timed up and go (TUG)

    Time frame: 5 days

    This will be measured as the time it takes a participant to rise from a chair, walk three meters at a self-selected pace, turn, walk back to the chair and sit down. The total time taken will be measured in seconds with longer times indicating poorer physical performance. This test assesses functional mobility and dynamic balance.

  3. 6 Minute Walk Test

    Time frame: 5 days

    This is a measurement of endurance and functional ability that assesses the participants ability to walk a distance over a time period of 6 minutes. It is measured in distance with greater distances indicating improved levels of endurance and functional ability.

  4. Modified Stroke Impact Scale

    Time frame: 5 days

    The Modified Stroke Impact Scale (SIS) is a self-report questionnaire that evaluates disability and health-related quality of life after stroke. Each item is rated in a 5-point Likert scale in terms of the difficulty the patient has experienced in completing each item. Scores are transformed to a 0-100 scale, with 0 indicating the poorest perceived health status and 100 indicating the best, across domains of disability and health-related quality of life. Higher scores are indicative of improved quality of life.

  5. Modified Activities-specific Balance Confidence

    Time frame: 5 days

    The modified activities specific balance confidence is a self-report measure of balance confidence in performing various activities without losing balance or experiencing a sense of unsteadiness. Confidence is rated for various activities on a scale from 0% to 100% for each activity, with 0% indicative of no confidence and 100% indicative of complete confidence. Scores reflect balance confidence with higher scores indicative of improved balance confidence.

  6. Fast Self-selected Walking Speed

    Time frame: 5 days

    This will be measured as the participant walks on a treadmill at their fastest and safest walking speed. This measure will be recorded in meters/seconds with higher values indicating faster speed and lower values indicating slower speeds.

Sponsors and collaborators

Lead sponsor

Georgia Institute of Technology

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Adaptive Hip Exoskeleton for Stroke Survivors With Gait Impairment

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 13, 2022
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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