NCT04578665

Brief 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 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
764

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2021

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
9 months until next milestone

Study Start

First participant enrolled

July 13, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

August 12, 2020

Last Update Submit

May 21, 2025

Conditions

Keywords

StrokeSpinal Cord InjuriesRobotic RehabilitationElectromyographyHaptic FeedbackDyadSkill LevelImpedance

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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.

    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.

    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.

    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)

    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)

    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.

  • +6 more secondary outcomes

Study Arms (4)

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.

Behavioral: Behavioral Interaction ConditionsDevice: Haptic Impedance LevelBehavioral: 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.

Behavioral: Behavioral Interaction ConditionsDevice: Haptic Impedance LevelBehavioral: 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.

Behavioral: Behavioral Interaction ConditionsDevice: Haptic Impedance LevelBehavioral: Skill Level of PartnerDevice: 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.

Behavioral: Behavioral Interaction ConditionsDevice: Haptic Impedance LevelBehavioral: Skill Level of PartnerDevice: Robot Controller Showcase

Interventions

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).

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)

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).

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)

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.

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)

The subjects will complete 10 training sessions per assistive robot for the researchers to observe motor learning and functional outcomes.

Clinical Populations Ankle Robot (M1)Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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
  • +13 more criteria

You may not qualify if:

  • 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
  • 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)
  • +28 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

  • 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. doi: 10.1186/s12984-025-01840-4. Online ahead of print.

MeSH Terms

Conditions

StrokeSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Jose Pons, Ph.D

    Shirley Ryan AbilityLab

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Pons, Ph.D

CONTACT

Grace Hoo, BS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 12, 2020

First Posted

October 8, 2020

Study Start

July 13, 2021

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Locations