StrokeHRCEMLNCT04578665
Human-like Robotic Controllers for Enhanced Motor Learning
A study testing Behavioral Interaction Conditions, Haptic Impedance Level and Skill Level of Partner in people with Stroke and Spinal Cord Injuries, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke, Spinal Cord Injuries
- What is being tested?
- Behavioral Interaction Conditions, Haptic Impedance Level and Skill Level of Partner
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2021to 15 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 to 80 years
- No history of a brain and/or skull lesion
- Normal hearing and vision, can be corrected
- Able to understand and give informed consent
- No neurological disorders
- Absence of pathology that could cause abnormal movements of extremities (e.g., epilepsy, stroke, marked arthritis, chronic pain, musculoskeletal injuries)
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- Able to understand and speak English
- Height between 3 foot 6 inches (1.1 meters) and 6 foot 2 inches
- Age from 18 to 80 years
- History of unilateral, supratentorial, ischemic or hemorrhage stroke greater than 6 month
- Ability to walk >10m independently on level ground, allowed to use assistive devices or bracing as needed
- Self-selected walking speed is less than 0.8 meters/sec
- Medically stable
- No concurrent surgeries, medical treatments, participation in research or outpatient therapy
- Normal hearing and vision, both can be corrected
- Able to understand and give informed consent
- Able to understand and speak English
- Height between 3 foot 6 inches (1.1 meters) and 6 foot 2 inches
- Inclusion Criteria for Participants with Spinal Cord Injury:
- Age from 18 to 80 years
- History of incomplete SCI injury (ASIA C or D) > 6 months prior
- Ability to walk >10 m independently on level ground, allowed to use assistive devices or bracing as needed
- Self-selected walking speed is less than 0.8 meters/sec
- Medically stable
- No concurrent surgeries, medical treatments, participation in research or outpatient therapy
- Normal hearing and vision, both can be corrected
- Able to understand and give informed consent
- Able to understand and speak English
- Height between 3 foot 6 inches (1.1 meters) and 6 foot 2 inches
Who cannot join
- Weight over 220 lbs
- Pregnancy (ruled out by pregnancy questionnaire)
- Current presence of wounds or pressure ulcers
- Multiple sclerosis, Parkinson's disease or other neurodegenerative disorder, severe dementia, brain injury, spinal cord injury, or cancer of the central nervous system
- History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
- Known structural brain lesion
Show all 44Show fewer
- Significant other disease (heart disease, malignant tumors, mental disorders)
- History or peripheral nerve injury
- History of sustained non-prescribed drug use or substance abuse (exception: current nicotine use is allowed)
- Prior neurosurgical procedures
- Inability or unwillingness to perform study-required activities
- Prisoners
- Unable to meet SRAlab "MRI Pre-Examination Screening Form" requirements
- Weight over 220 lbs
- Pregnancy (ruled out by pregnancy test)
- Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned injection during study period.
- Current presence of wounds or pressure ulcers
- History of sustained non-prescribed drug use or substance abuse (exception: current nicotine use is allowed)
- Reduced cognitive function
- Severe aphasia
- Prisoners
- Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, severe dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system)
- History or peripheral nerve injury
- Severe hip, knee, or ankle arthritis
- Recent fracture or osteoporosis
- Significant spasticity in the lower limbs (≥3 on Modified Ashworth Scale)
- Medical (cardiac, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures
- Inability or unwillingness to perform study-required activities
- Unable to meet SRAlab "MRI Pre-Examination Screening Form" requirements
- Exclusion Criteria for Participants with Spinal Cord Injury:
- Weight over 220 lbs
- Pregnancy (ruled out by pregnancy test)
- Botox (botulinum toxin) injection to lower limbs within the prior 3 months, or planned injection during study period
- Current presence of wounds or pressure ulcers
- History of sustained non-prescribed drug use or substance abuse (exception: current nicotine use is allowed)
- Prisoners
- Co-existence of other neurological diseases (e.g., Parkinson's disease or other neurodegenerative disorder, severe dementia, brain injury, spinal cord injury, multiple sclerosis, or cancer of the central nervous system)
- History of peripheral nerve injury
- Severe hip, knee, or ankle arthritis
- Recent fracture or osteoporosis
- Significant spasticity in the lower limbs ( ≥3 on Modified Ashworth Scale)
- Medical (cardiac, renal, hepatic, oncological) or psychiatric disease that would interfere with study procedures
- Inability or unwillingness to perform study-required activities
- Unable to meet SRAlab "MRI Pre-Examination Screening Form" requirements
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other co-robots. The investigators will develop models for a single joint robot (i.e. at the ankle joint) that can vary its haptic behavioral interactions at variable impedances, and replicate in a multi-joint robot (i.e. at the ankle, knee, and hip joints). The investigators will collect data from healthy participants and clinical populations to create a controller based on our models to implement in the robots. Then, the investigators will test our models via the robots to investigate the mechanisms underlying enhanced motor learning during different human-human haptic interaction behaviors (i.e. collaboration, competition, and cooperation. This study will be carried out in healthy participants, participants post-stroke, and participants with spinal cord injury (SCI).
Read the detailed description
The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected by 1) different behavioral interaction conditions (i.e., solo task, collaboration task, competition task, or cooperation task); 2) the haptic impedance or stiffness of the virtual connection between dyadic peers (i.e., hard connection, medium connection, or soft connection); and 3) the skill level of the other partner (i.e., novice or expert). The investigators will be using both an ankle robot (M1 device) and a bilateral lower limb exoskeleton (H3/X2 device), and will collect EMG and EEG data.
For Experiment A , the investigators will recruit healthy volunteers (n = 180) to work in dyadic pairs. With the collected data, the investigators will model how humans adapt force and impedance and share roles/specialize during various dyadic interaction behaviors, and use this knowledge to develop robot controllers that mimic movement error and force adaptation for enhanced motor performance.
For Experiment B , the investigators will recruit healthy volunteers (n = 260), participants post-stroke (n = 88) and participants post-SCI (n = 88) to work in dyadic pairs within each population. The investigators will test the robot controllers following the models for mechanical adaptation and role sharing strategies between peers based on Experiment A. The investigators will also monitor single-joint and multi-joint movement error and force adaptation in regards to enhanced motor performance. The investigators will assess if the robot controllers can pass a "haptic Turing Test", rendering them indistinguishable with respect to human peers. A structural MRI will be obtained to be used for EEG source analysis.
For Experiment C, the investigators will showcase the robot controllers by interfacing with participants post-stroke (n = 4) and participants post-SCI (n = 4) with the single-joint and multi-joint assistive robots to observe motor learning and functional outcomes with 10 training sessions per robot.
- Conditions
- Stroke, Spinal Cord Injuries
- Being tested
- Behavioral Interaction Conditions, Haptic Impedance Level, Skill Level of Partner, Robot Controller Showcase
- Keywords
- Stroke, Spinal Cord Injuries, Robotic Rehabilitation, Electromyography, Haptic Feedback, Dyad, Skill Level, Impedance
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Interaction ConditionsBehavioural
The participants will be single-blinded and complete a tracking task as either: solo task, collaboration task (both participants work on a common task synchronously to achieve a goal; this is a summative effort to achieve the goal), competition task (each participant has to achieve a goal at the expense of his or her partner, therefore maximizing effort or error of the partner in reaching the goal), or cooperation task (an asymmetric partnership with an active partner and a passive partner working towards a goal).
Haptic Impedance LevelDevice
The subjects will complete their task at 3 impedance levels: high (a virtual stiffness 160-200 N/m and damping 0~10 Nm/s; this will be a stiff connection in which the subjects feel like they are connected via rigid links and each subject will perceive the other partner's movement directly), medium (a virtual stiffness 100-140 N/m and damping 0~10 Nm/s; this will be a spring like-connection in which the subjects feel like they are connected with a spring and each subject will perceive the other partner with a force that is proportional to the trajectory difference of the two participants), and soft (a virtual stiffness 40-80 N/m and damping 0~10 Nm/s; this will be a spring like connection in which the subjects feel like they are connected with a loose spring and each subject will perceive the other partner with a force that is proportional to the trajectory difference of the two subjects, however, this force will be smaller than that of the medium impedance).
Skill Level of PartnerBehavioural
There will be two skill levels: novice (a participant who has no prior experience with the trajectory tracking experiment; in testing with the clinical populations, the investigators will assign this condition to the clinical participant) and expert (a participant who is experienced with the trajectory tracking experiment and who can achieve a tracking error [difference of the desired trajectory and actual trajectory] below a certain threshold; in testing with the clinical population, the investigators will assign this condition to the therapist). Participants will start experimentation paired as novice-novice, and at the end of the session may be invited to continue additional sessions to be paired as the expert in a novice-expert dyad.
Robot Controller ShowcaseDevice
The subjects will complete 10 training sessions per assistive robot for the researchers to observe motor learning and functional outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Participants Ankle Robot (M1) | Experimental | The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. Receives: Behavioral: Behavioral Interaction Conditions; Device: Haptic Impedance Level; Behavioral: Skill Level of Partner |
| Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2) | Experimental | The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. Receives: Behavioral: Behavioral Interaction Conditions; Device: Haptic Impedance Level; Behavioral: Skill Level of Partner |
| Clinical Populations Ankle Robot (M1) | Experimental | The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. Receives: Behavioral: Behavioral Interaction Conditions; Device: Haptic Impedance Level; Behavioral: Skill Level of Partner; Device: Robot Controller Showcase |
| Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2) | Experimental | The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. Receives: Behavioral: Behavioral Interaction Conditions; Device: Haptic Impedance Level; Behavioral: Skill Level of Partner; Device: Robot Controller Showcase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in lower limb motor control.
Lower limb motor control will be assessed through analysis of tracking movements to a target trajectory. If the tracking error decreases, this corresponds to motor control improvement.
Measured: Motor control will be measured all 10 sessions through study completion, an average of 12 weeks.
Change in motor output from surface EMG of lower limb muscles
For Experiment A and B with M1: the surface EMG activation patterns of the gastrocnemius and tibialis anterior muscles will be collected. For Experiment A and B with H3/X2, the surface EMG of the gluteus maximus, biceps femoris, tensor fasciae latae, rectus femoris, vastus lateralis, gastrocnemius medialis, soleus, and tibialis anterior muscles will be collected.
Measured: Change of motor output at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Secondary outcomes (11)
Change in 6 minute walking test.
Physical function test measuring the total distance walked in a span of six minutes will be assessed. A shorter time indicates improvement.
Measured: Change of ambulation distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in 10 meter walking test.
Physical function test measuring the walking speed in a span of 10 meters will be assessed. A shorter time indicates improvement in walking speed.
Measured: Change of ambulation distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in Modified Ashworth Scale.
Spasticity of lower extremity muscles will be assessed using the Modified Ashworth Scale. The minimum score of 0 means no increase in spasticity and the maximum score of 4 means the body part is rigid in flexion or extension. A lower score indicates a better outcome.
Measured: Change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in BERG balance scale (BBS)
Static and dynamic sitting and standing balance will be assessed using the BERG balance scale. The scale ranges from 0 to 56, and a higher score indicates better balance and decreased fall risk.
Measured: Change of score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in functional gait assessment (FGA)
Balance while walking will be assessed using the functional gait assessment (FGA). This has a scale of 0 to 30, with the higher score indicating better balance and decreased fall risk.
Measured: Change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in strength via dynamometer testing.
Change in strength will be assessed via the maximum voluntary contraction for joints with a dynamometer.
Measured: Change in strength at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in stride variability.
Stride variability is the ratio between the standard-deviation and mean of stride time, expressed as percentage. Decreased variability indicates a better outcome.
Measured: Change in stride variability at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in cadence.
Cadence is the total number of steps taken within a given time period; often expressed per minute. Typically a higher number of steps is a better outcome.
Measured: Change in number of steps at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in step length.
Step length is the distance between the point of initial contact of one foot and the point of initial contact of the opposite foot. Typically a longer step length is a better outcome, ideally with equal measurements between left and right limbs.
Measured: Change in distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in stride length.
Stride length is the distance between successive points of initial contact of the same foot. Right and left stride lengths are normally equal. Typically a longer stride length is a better outcome, ideally with equal measurements between left and right limbs.
Measured: Change in distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in stance time.
Stance time is the amount of time that passes during the stance phase of one extremity in a gait cycle. It includes single support and double support. Equal stance time between limbs is a better outcome.
Measured: Change in stance time at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start13 Jul 2021
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (estimated)
Why it stopped: Study pending of pending that could not be secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other co-robots.
- Masking
- None (open label)
- Enrolment
- 764 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation
- Responsible party
- Principal investigator, Jose Pons, Shirley Ryan AbilityLab
- Investigators
- Jose Pons, Ph.D, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578665
- Sponsor's protocol ID
- STU00212684
- Acronym
- HRCEML
- Status last verified
- Jul 2026
- First submitted
- 12 Aug 2020
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Short MR, Bandini L, Ludvig D, Vianello L, Sanguineti V, Pons JL. Haptic interaction with a human partner for ankle training in chronic stroke: a pilot study. J Neuroeng Rehabil. 2025 Dec 18;23(1):32. doi: 10.1186/s12984-025-01840-4.
PubMed 41413829Short MR, Ludvig D, Kucuktabak EB, Wen Y, Vianello L, Perreault EJ, Hargrove L, Lynch K, Pons JL. Haptic Human-Human Interaction During an Ankle Tracking Task: Effects of Virtual Connection Stiffness. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3864-3873. doi: 10.1109/TNSRE.2023.3319291. Epub 2023 Oct 5.
PubMed 37747854
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human-like Robotic Controllers for Enhanced Motor Learning
- ClinicalTrials.gov ID
- NCT04578665
- Acronym / sponsor ID
- HRCEML / STU00212684
- Conditions
- Stroke, Spinal Cord Injuries
- Keywords
- Stroke, Spinal Cord Injuries, Robotic Rehabilitation, Electromyography, Haptic Feedback, Dyad, Skill Level, Impedance
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study pending of pending that could not be secured
- Enrolment
- 764 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other co-robots. The investigators will develop models for a single joint robot (i.e. at the ankle joint) that can vary its haptic behavioral interactions at variable impedances, and replicate in a multi-joint robot (i.e. at the ankle, knee, and hip joints). The investigators will collect data from healthy participants and clinical populations to create a controller based on our models to implement in the robots. Then, the investigators will test our models via the robots to investigate the mechanisms underlying enhanced motor learning during different human-human haptic interaction behaviors (i.e. collaboration, competition, and cooperation. This study will be carried out in healthy participants, participants post-stroke, and participants with spinal cord injury (SCI).
Detailed description
The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected by 1) different behavioral interaction conditions (i.e., solo task, collaboration task, competition task, or cooperation task); 2) the haptic impedance or stiffness of the virtual connection between dyadic peers (i.e., hard connection, medium connection, or soft connection); and 3) the skill level of the other partner (i.e., novice or expert). The investigators will be using both an ankle robot (M1 device) and a bilateral lower limb exoskeleton (H3/X2 device), and will collect EMG and EEG data.
For Experiment A , the investigators will recruit healthy volunteers (n = 180) to work in dyadic pairs. With the collected data, the investigators will model how humans adapt force and impedance and share roles/specialize during various dyadic interaction behaviors, and use this knowledge to develop robot controllers that mimic movement error and force adaptation for enhanced motor performance.
For Experiment B , the investigators will recruit healthy volunteers (n = 260), participants post-stroke (n = 88) and participants post-SCI (n = 88) to work in dyadic pairs within each population. The investigators will test the robot controllers following the models for mechanical adaptation and role sharing strategies between peers based on Experiment A. The investigators will also monitor single-joint and multi-joint movement error and force adaptation in regards to enhanced motor performance. The investigators will assess if the robot controllers can pass a "haptic Turing Test", rendering them indistinguishable with respect to human peers. A structural MRI will be obtained to be used for EEG source analysis.
For Experiment C, the investigators will showcase the robot controllers by interfacing with participants post-stroke (n = 4) and participants post-SCI (n = 4) with the single-joint and multi-joint assistive robots to observe motor learning and functional outcomes with 10 training sessions per robot.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The purpose of this study is to develop a new paradigm to understand how humans physically interact with each other at a single and at multiple joints, with multiple contact points, so as to synthesize robot controllers that can exhibit human-like behavior when interacting with humans (e.g., exoskeleton) or other co-robots.
| Arm | Type | Receives |
|---|---|---|
| Healthy Participants Ankle Robot (M1) | Experimental | Behavioral: Behavioral Interaction Conditions, Device: Haptic Impedance Level, Behavioral: Skill Level of PartnerThe investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. |
| Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2) | Experimental | Behavioral: Behavioral Interaction Conditions, Device: Haptic Impedance Level, Behavioral: Skill Level of PartnerThe investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. |
| Clinical Populations Ankle Robot (M1) | Experimental | Behavioral: Behavioral Interaction Conditions, Device: Haptic Impedance Level, Behavioral: Skill Level of Partner, Device: Robot Controller ShowcaseThe investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. |
| Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2) | Experimental | Behavioral: Behavioral Interaction Conditions, Device: Haptic Impedance Level, Behavioral: Skill Level of Partner, Device: Robot Controller ShowcaseThe investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Age from 18 to 80 years
- No history of a brain and/or skull lesion
- Normal hearing and vision, can be corrected
- Able to understand and give informed consent
- No neurological disorders
Key exclusion criteria (44 listed)
- Weight over 220 lbs
- Pregnancy (ruled out by pregnancy questionnaire)
- Current presence of wounds or pressure ulcers
- Multiple sclerosis, Parkinson's disease or other neurodegenerative disorder, severe dementia, brain injury, spinal cord injury, or cancer of the central nervous system
- History of significant head trauma (i.e., extended loss of consciousness, neurological sequelae)
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 |
|---|---|---|
| Behavioral Interaction ConditionsThe participants will be single-blinded and complete a tracking task as either: solo task, collaboration task (both participants work on a common task synchronously to achieve a goal; this is a summative effort to achieve the goal), competition task (each participant has to achieve a goal at the expense of his or her partner, therefore maximizing effort or error of the partner in reaching the goal), or cooperation task (an asymmetric partnership with an active partner and a passive partner working towards a goal). | Behavioural | Clinical Populations Ankle Robot (M1), Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2), Healthy Participants Ankle Robot (M1), Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2) |
| Haptic Impedance LevelThe subjects will complete their task at 3 impedance levels: high (a virtual stiffness 160-200 N/m and damping 0~10 Nm/s; this will be a stiff connection in which the subjects feel like they are connected via rigid links and each subject will perceive the other partner's movement directly), medium (a virtual stiffness 100-140 N/m and damping 0~10 Nm/s; this will be a spring like-connection in which the subjects feel like they are connected with a spring and each subject will perceive the other partner with a force that is proportional to the trajectory difference of the two participants), and soft (a virtual stiffness 40-80 N/m and damping 0~10 Nm/s; this will be a spring like connection in which the subjects feel like they are connected with a loose spring and each subject will perceive the other partner with a force that is proportional to the trajectory difference of the two subjects, however, this force will be smaller than that of the medium impedance). | Device | Clinical Populations Ankle Robot (M1), Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2), Healthy Participants Ankle Robot (M1), Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2) |
| Skill Level of PartnerThere will be two skill levels: novice (a participant who has no prior experience with the trajectory tracking experiment; in testing with the clinical populations, the investigators will assign this condition to the clinical participant) and expert (a participant who is experienced with the trajectory tracking experiment and who can achieve a tracking error [difference of the desired trajectory and actual trajectory] below a certain threshold; in testing with the clinical population, the investigators will assign this condition to the therapist). Participants will start experimentation paired as novice-novice, and at the end of the session may be invited to continue additional sessions to be paired as the expert in a novice-expert dyad. | Behavioural | Clinical Populations Ankle Robot (M1), Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2), Healthy Participants Ankle Robot (M1), Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2) |
| Robot Controller ShowcaseThe subjects will complete 10 training sessions per assistive robot for the researchers to observe motor learning and functional outcomes. | Device | Clinical Populations Ankle Robot (M1), Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2) |
Primary outcome
Change in lower limb motor control.
Time frame: Motor control will be measured all 10 sessions through study completion, an average of 12 weeks.
Lower limb motor control will be assessed through analysis of tracking movements to a target trajectory. If the tracking error decreases, this corresponds to motor control improvement.
Change in motor output from surface EMG of lower limb muscles
Time frame: Change of motor output at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
For Experiment A and B with M1: the surface EMG activation patterns of the gastrocnemius and tibialis anterior muscles will be collected. For Experiment A and B with H3/X2, the surface EMG of the gluteus maximus, biceps femoris, tensor fasciae latae, rectus femoris, vastus lateralis, gastrocnemius medialis, soleus, and tibialis anterior muscles will be collected.
11 secondary outcomes
Change in 6 minute walking test.
Time frame: Change of ambulation distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in 10 meter walking test.
Time frame: Change of ambulation distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in Modified Ashworth Scale.
Time frame: Change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in BERG balance scale (BBS)
Time frame: Change of score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in functional gait assessment (FGA)
Time frame: Change in score at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in strength via dynamometer testing.
Time frame: Change in strength at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in stride variability.
Time frame: Change in stride variability at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in cadence.
Time frame: Change in number of steps at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in step length.
Time frame: Change in distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in stride length.
Time frame: Change in distance at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Change in stance time.
Time frame: Change in stance time at baseline, midpoint of intervention after 10 training sessions with assistive robot, and endpoint after 10 additional training sessions with the other assistive robot through participant completion, an average of 5 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Derived from this study: PubMed 41413829Short MR, Bandini L, Ludvig D, Vianello L, Sanguineti V, Pons JL. Haptic interaction with a human partner for ankle training in chronic stroke: a pilot study. J Neuroeng Rehabil. 2025 Dec 18;23(1):32. doi: 10.1186/s12984-025-01840-4.
- Derived from this study: PubMed 37747854Short MR, Ludvig D, Kucuktabak EB, Wen Y, Vianello L, Perreault EJ, Hargrove L, Lynch K, Pons JL. Haptic Human-Human Interaction During an Ankle Tracking Task: Effects of Virtual Connection Stiffness. IEEE Trans Neural Syst Rehabil Eng. 2023;31:3864-3873. doi: 10.1109/TNSRE.2023.3319291. Epub 2023 Oct 5.
- Individual participant dataSharing planned: Undecided
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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.
Jose Pons, Ph.D principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Interaction Conditions, Haptic Impedance Level and Skill Level of Partner in people with Stroke and Spinal Cord Injuries, run by Shirley Ryan AbilityLab 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 29 inclusion and 44 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: paused, as of the sponsor's last update on 14 Jul 2026. 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?
Results are not available in the source record.
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?
Change in lower limb motor control. (time frame: Motor control will be measured all 10 sessions through study completion, an average of 12 weeks.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578665, which also lists 2 linked publications.
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 14 Jul 2026.