Robotic Controllers for Motor Learning After Neurological Injuries

(HRCEML Trial)

Overseen By Jose Pons, Ph.D

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Must not be taking: Botox

Disqualifiers: Pregnancy, Neurological diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 40

764 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests robotic devices that help people improve movement after neurological injuries like strokes or spinal cord injuries. The researchers aim to develop robots that interact naturally with humans to enhance movement in the ankle, knee, and hip. These human-like robotic controllers assist in motor learning. The study involves participants who are healthy, have had a stroke, or have a spinal cord injury. Ideal candidates can walk short distances independently but struggle with speed or stability. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in robotic rehabilitation.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it mentions that participants should not have concurrent medical treatments, which might imply some restrictions. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that these robotic controllers are safe for motor learning after neurological injuries?

Previous studies have found that robotic devices assist in relearning movement. These studies explored human-robot interactions. The treatments are easy to handle, with no serious side effects reported. Researchers use robots to make movements feel more natural, mimicking human motion.

In these studies, robots help people regain movement after injuries like strokes or spinal cord injuries. Their safety is supported by use in other research settings without major issues. Overall, research shows these treatments are safe for humans, based on existing data and experiences. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using human-like robotic controllers for motor learning after neurological injuries because these devices offer a new way to enhance physical rehabilitation. Unlike traditional therapies that rely on manual guidance and repetitive exercises, these robotic controllers provide precise, consistent support tailored to each individual's needs. The technology allows for real-time adaptation during movement, improving task performance and motor outcomes. By focusing on dyadic physical interactions, this approach aims to optimize recovery by making rehabilitation more interactive and responsive, potentially leading to faster and more effective rehabilitation outcomes.

What evidence suggests that these robotic controllers are effective for motor learning after neurological injuries?

Research has shown that robotic devices can significantly aid individuals with neurological injuries, such as those from a stroke or spinal cord injury, in improving movement. Studies have found that these devices can mimic human interactions, enhancing movement. In this trial, participants will join different treatment arms to assess the effectiveness of robotic devices. One arm involves healthy participants using an ankle robot, while another involves clinical populations using the same device. Additionally, there are arms for both healthy participants and clinical populations using a bilateral lower limb exoskeleton. These findings suggest that robotic devices could effectively help patients regain mobility. ^{1 2 3 4 5}

Who Is on the Research Team?

Jose Pons, Ph.D

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-80 with normal hearing and vision, who can understand English and give informed consent. It's suitable for healthy participants as well as those post-stroke or with spinal cord injury (SCI), provided they can walk over 10m independently. People with brain lesions, neurological disorders, abnormal limb movements, or outside the height range of 3'6" to 6'2" cannot join.

Inclusion Criteria

Height between 3 foot 6 inches (1.1 meters) and 6 foot 2 inches

I had a stroke more than 6 months ago.

I can walk more than 10 meters by myself, even with help from devices.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experiment A

Recruitment of healthy volunteers to model human adaptation in dyadic interactions and develop robot controllers

12 weeks

10 sessions

Experiment B

Testing robot controllers with healthy volunteers, post-stroke, and SCI participants to assess mechanical adaptation and role sharing

5 months

20 sessions

Experiment C

Showcasing robot controllers with post-stroke and SCI participants to observe motor learning and functional outcomes

5 months

10 sessions per robot

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Human-like Robotic Controllers

Trial Overview The study aims to develop robot controllers that mimic human behavior in physical interactions. These will be tested on single joint (ankle) and multi-joint (ankle, knee, hip) robots using variable haptic behaviors like collaboration and competition to enhance motor learning in humans.

How Is the Trial Designed?

Group I: Healthy Participants Bilateral Lower Limb Exoskeleton (H3/X2) Experimental Treatment 3 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Group II: Healthy Participants Ankle Robot (M1) Experimental Treatment 3 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Group III: Clinical Populations Bilateral Lower Limb Exoskeleton (H3/X2) Experimental Treatment 4 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Group IV: Clinical Populations Ankle Robot (M1) Experimental Treatment 4 Interventions

The investigators will look at how the task performance and motor performance of individuals in dyadic physical interactions are affected.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

U.S. National Science Foundation

Collaborator

Trials

35

Recruited

9,000+

Published Research Related to This Trial

A pilot study involving 9 healthy subjects and 2 stroke patients explored the use of a multi-joint exoskeleton for robotic assistance during motor imagery tasks, showing that proprioceptive feedback improved control and performance of the robotic movements.

The study suggests that brain-robot interfaces (BRIs) could enhance rehabilitation by linking robotic training to the user's brain activity, potentially allowing for personalized adjustments in task difficulty to aid motor learning and recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain state-dependent robotic reaching movement with a multi-joint arm exoskeleton: combining brain-machine interfacing and robotic rehabilitation. Brauchle, D., Vukelić, M., Bauer, R., et al.[2020]

A novel adaptive controller for robot-aided movement training after stroke was developed, featuring high mechanical compliance and the ability to provide only the necessary assistance to patients, enhancing their engagement in therapy.

Tests with the Pneu-WREX robotic device showed that the 'assist-as-needed' approach improved patient participation and demonstrated the natural tendency of patients to rely on the robot for support when they could, which helps in motor learning and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing compliant, model-based robotic assistance to promote neurorehabilitation. Wolbrecht, ET., Chan, V., Reinkensmeyer, DJ., et al.[2022]

Healthy subjects successfully learned to control a cursor using shoulder and upper arm movements, demonstrating the potential for optimizing movement reorganization in individuals with neuromotor disorders.

With practice, participants improved their cursor control, achieving faster, smoother, and more precise movements, which suggests that similar training could enhance the effectiveness of assistive devices for disabled users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional reorganization of upper-body movements for wheelchair control. Casadio, M., Pressman, A., Danziger, Z., et al.[2020]

The Tele-REINVENT system, a low-cost telerehabilitation biofeedback tool, has been developed to help stroke survivors improve muscle control at home, showing feasibility and safety in a case study with one stroke patient over 40 sessions in 10 weeks.

Preliminary results indicate that the system can effectively train differentiated muscle activity and reduce unwanted co-contractions, suggesting it could be a valuable tool for personalized rehabilitation in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Low-Cost, Modular Muscle-Computer Interface for At-Home Telerehabilitation for Chronic Stroke. Marin-Pardo, O., Phanord, C., Donnelly, MR., et al.[2021]

Exoskeletons are advanced wearable robots designed to assist individuals with motor disorders, enhancing rehabilitation through close cognitive and physical interaction with users.

Key areas for future development include improving the safety and reliability of human-robot interactions, ensuring the exoskeletons are portable and user-friendly, and addressing user acceptance to maximize their effectiveness in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation exoskeletal robotics. The promise of an emerging field. Pons, JL.[2010]

Robotic rehabilitation technologies have not shown significantly better patient outcomes compared to traditional therapy, but they can reduce the physical workload for therapists during high-intensity interventions.

Involving therapists more directly in the control of robotic systems may enhance rehabilitation effectiveness by fostering better patient-therapist-robot interactions and promoting neuroplastic changes essential for recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurorehabilitation robotics: how much control should therapists have? Hasson, CJ., Manczurowsky, J., Collins, EC., et al.[2023]

The study involving 46 subacute stroke patients demonstrated that overground exoskeleton-assisted gait training (OEAGT) significantly improved clinical and gait outcomes, with many patients regaining the ability to walk after treatment.

Patients reported a positive acceptance of the OEAGT, indicating its potential as an innovative rehabilitation strategy, although further randomized studies with larger samples are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground wearable powered exoskeleton for gait training in subacute stroke subjects: clinical and gait assessments. Goffredo, M., Guanziroli, E., Pournajaf, S., et al.[2020]

In a study involving 27 chronic stroke patients, both robotic and non-robotic rehabilitation techniques led to similar improvements in movement ability, indicating that these methods may activate a common recovery mechanism.

The recovery process followed a similar exponential time course of about 4-5 weeks for both training techniques, suggesting that the effectiveness of rehabilitation may depend more on the engagement of the nervous system rather than the specific method used.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do robotic and non-robotic arm movement training drive motor recovery after stroke by a common neural mechanism? Experimental evidence and a computational model. Reinkensmeyer, DJ., Maier, MA., Guigon, E., et al.[2020]

Robotic systems for neuromotor rehabilitation have been used in clinical practice for over a decade, but their effectiveness remains uncertain due to a lack of consensus on key features and theoretical foundations for treatment protocols.

The authors propose a 'research pipeline' that includes validated models of neural control, motor learning, and functional recovery to improve the design of robotic therapies and facilitate better comparisons in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot therapy of the upper limb in stroke patients: preliminary experiences for the principle-based use of this technology. Casadio, M., Giannoni, P., Masia, L., et al.[2016]

Robot-assisted rehabilitation therapy for neurological patients aims to enhance motor plasticity through repetitive and task-oriented training, with a focus on adapting to the patient's recovery stage.

The paper proposes a three-level classification system for developing effective upper-limb rehabilitation exoskeletons, emphasizing the importance of compliant control strategies that foster collaboration between the robot and the patient to improve rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review on Patient-Cooperative Control Strategies for Upper-Limb Rehabilitation Exoskeletons. Dalla Gasperina, S., Roveda, L., Pedrocchi, A., et al.[2021]

Citations

1. withpower.com withpower.com/trial/phase-spinal-cord-injuries-6-2021-14bfe

Robotic Controllers for Motor Learning After Neurological Injuries 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, ...

2. sralab.org sralab.org/research/labs/pons-lab/projects/co-robot-controllers-human-physical-interaction-and-improved-motor-learning

Co-Robot Controllers for Human-Like Physical Interaction ... The vision of this work is to understand the underlying mechanisms of human dyadic physical interaction that lead to improvement in motor ...

3. arxiv.org arxiv.org/pdf/2507.17561

Robot-mediated physical Human-Human Interaction in ... This framework, which enables two individuals to physically interact through robotic devices, has been studied across diverse research groups.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8714449/

Human-machine-human interaction in motor control and ... We review recent research on the impact of HMH interaction on task performance and individual motor learning in the context of motor control and rehabilitation.

5. researchgate.net researchgate.net/publication/357361919_Human-machine-human_interaction_in_motor_control_and_rehabilitation_a_review

Human-machine-human interaction in motor control and ... We review recent research on the impact of HMH interaction on task performance and individual motor learning in the context of motor control and ...