Motor Relearning and Sensory Rehabilitation for Stroke

Recruiting at 1 trial location

Overseen By Soh-Hyun Hur

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: University of Maryland, Baltimore

Disqualifiers: Medically unstable, Severe cardiovascular, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

68 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable rehabilitation robot designed to aid stroke recovery. The goal is to enhance movement and sensation in patients who have recently experienced a stroke, particularly those with limited leg mobility. Participants are divided into two groups: one will use the robot for motor relearning and movement support, while the control group will use it in a limited manner. This trial is ideal for individuals who have had a stroke on one side of the brain and face issues like weak or stiff ankle muscles. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

What prior data suggests that this wearable rehabilitation robot is safe for stroke rehabilitation?

A previous study found the wearable ankle robot used for stroke recovery to be safe and effective. Research shows that users interact with the ankle robot comfortably and naturally. Another study found that the ankle robot improved walking in stroke patients without causing major side effects. These findings suggest that the wearable robot is safe, offering support and aid in recovery without significant risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the wearable rehabilitation robot for stroke recovery because it offers a fresh approach to motor relearning and sensory rehabilitation. Unlike standard physical therapy, which often relies on manual exercises and therapist feedback, this robotic device provides real-time feedback and intelligent control for passive stretching. This allows for more precise and personalized training. Additionally, the robot assists with active movement training, potentially accelerating recovery by helping patients regain mobility more effectively than traditional methods.

What evidence suggests that this wearable rehabilitation robot is effective for stroke rehabilitation?

Research shows that robot-assisted therapy can improve ankle movement and balance in stroke patients. Studies have found that this therapy enhances walking ability and movement skills. In this trial, participants in the study group will use a wearable ankle robot for motor relearning with real-time feedback and active movement training with robotic assistance. Meanwhile, the control group will use the same wearable robot in a limited way, without motor relearning training or robotic assistance. Evidence suggests that wearable ankle robots support the intensive training needed for stroke recovery, particularly during the crucial early months after a stroke. These findings indicate that the wearable rehabilitation robot could be effective for stroke recovery. ^{3 6 7 8 9}

Who Is on the Research Team?

Li-Qun Zhang

Principal Investigator

University of Maryland

Are You a Good Fit for This Trial?

This trial is for acute stroke survivors aged 30-85 with hemiplegia or hemiparesis, experiencing their first unilateral stroke. They should be within 1 month post-stroke and have limited ankle movement or stiff calf muscles. Those with severe muscle weakness (MMT >2) are excluded.

Inclusion Criteria

I have weakness or paralysis on one side of my body.

My muscle strength score is between 0 and 2.

I am between 30 and 85 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo robot-guided motor relearning, passive and active motor-sensory rehabilitation using a wearable rehabilitation robot

3 weeks

Multiple sessions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 visit (in-person) at 1 month post-treatment

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Rehabilitation Robot

Trial Overview The study tests a wearable rehabilitation robot designed for in-bed use during the acute stage of stroke recovery. It includes robot-guided motor relearning, passive stretching, game-based active training, and measurement of ankle torque/motion.

How Is the Trial Designed?

Group I: Study group - Wearable ankle robot rehab Experimental Treatment 3 Interventions

Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance

Group II: Control group - Limited wearable ankle robot rehab Active Control 3 Interventions

The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

The University of Texas Health Science Center, Houston

Collaborator

Trials

974

Recruited

361,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3636117/

Effectiveness of robot-assisted therapy on ankle rehabilitation The aim of this study was to provide a systematic review of studies that investigated the effectiveness of robot-assisted therapy on ankle motor and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02369770

NCT02369770 | Sensory-Motor Rehabilitation Post Stroke Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective ...

3. frontiersin.org frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2025.1549379/full

Effect of robot-assisted training for lower limb rehabilitation ... Robot-assisted training for lower limb rehabilitation may considerably enhance motor function, walking capacity, and balance function in stroke patients.

4. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-021-00814-6

Effects of wearable ankle robotics for stair and over-ground ... Wearable ankle robotics could potentially facilitate intensive repetitive task-specific gait training on stair environment for stroke rehabilitation.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1746809421007941

Wearable sensors and machine learning in post-stroke ... The objective of this review is to assess the recent developments made in the field of post-stroke rehabilitation using wearable devices for data collection ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6700322/

Wearable Ankle Robots in Post-stroke Rehabilitation of Gait Control strategies are an integral part of the wearable ankle robot and aim to create a safe, comfortable, and natural human-computer interaction environment.

7. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01624-w

A wearable ankle-assisted robot for improving gait function ... A newly developed wearable ankle-assist robot, the GEMS-A, is a potentially useful walking assist device for improving gait function and pattern in stroke ...

8. link.springer.com link.springer.com/chapter/10.1007/978-981-99-6489-5_48

The Feasibility, Safety and Efficacy of Robot-Assisted Gait ... The ankle robot has good safety and robustness in clinical practice, and could induce considerable improvement in locomotor function in patients ...

9. mhealth.jmir.org mhealth.jmir.org/2023/1/e40416

Clinical Study of a Wearable Remote Rehabilitation Training ... This study aims to design a remote intelligent rehabilitation training system based on wearable devices and human-computer interaction training tasks.