Assistance Devices for Stroke

Overseen By Sang Wook Lee, PhD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The Catholic University of America

Disqualifiers: Severe illness, Pain, Loss of control, others

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

Compensation: Varies

Number of Visits: 2

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of devices to assist finger movement in individuals who have experienced a stroke. Participants will use each device: one provides fingertip assistance (end-effector assistance), and the other aids finger extension (exotendon assistance). The aim is to determine which device more effectively aids movement and improves muscle activity in the hand. This trial suits those who had a stroke at least six months ago and have difficulty moving one side of their body. As an Early Phase 1 trial, the research focuses on understanding how these innovative devices function in people, offering participants the chance to explore new treatment possibilities.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these assistance devices are safe for stroke survivors?

Research has shown that both end-effector and exotendon devices have been safely used in studies with stroke patients. For end-effector devices, studies have found that robotic systems are generally safe, with no major problems reported. These systems assist with limb movement and are designed to avoid harm.

Similarly, exotendon devices, often used in exoskeletons, have also demonstrated safety. Studies report improvements in walking speed and endurance in people with chronic stroke, without serious safety issues. This suggests that these devices are safe and well-accepted by patients.

Since this trial is in its early stages, it primarily focuses on assessing safety and device tolerance. Both devices have undergone previous testing and appear safe for stroke rehabilitation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke recovery because they offer novel ways to assist movement. The exotendon assistance is unique as it mimics natural muscle movements, potentially offering more precise support than traditional rehabilitation tools. Meanwhile, the end-effector assistance focuses on guiding limb movements directly, which can help retrain motor skills by providing consistent, controlled assistance. These approaches aim to enhance the quality and speed of recovery by leveraging advanced technology to support and retrain the body's natural movements.

What evidence suggests that these assistance devices are effective for stroke recovery?

This trial will compare end-effector assistance and exotendon assistance for stroke recovery. Research has shown that end-effector assistance holds promise for stroke recovery, with studies finding it superior in improving arm and leg movement. It is particularly effective for patients recovering from a stroke. In contrast, exotendon assistance, another treatment option in this trial, has improved leg strength and walking ability, aiding stroke patients in regaining some normal movement. Overall, both treatments offer hope for better recovery of movement after a stroke. ^{2 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for people aged 18-70 who had their first-ever stroke at least 6 months ago, affecting one side of the body but still have some arm and hand movement. Control subjects without a stroke can also join. People with severe illnesses, pain in the moving arm or hand, no finger control, or recent injuries are excluded.

Inclusion Criteria

I had a stroke affecting one side of my brain over 6 months ago, causing weakness on one side of my body.

I am between 18 and 70 years old.

Fugl-Meyer Upper Extremity Section 31 - 55 for stroke survivors

Exclusion Criteria

I have a severe illness alongside my cancer.

I am unable to understand or sign the consent form.

I experience pain in my hand or arm when I move it.

Timeline for a Trial Participant

Pre-experimental session

Reflective markers and EMG electrodes are placed, and maximum muscle contractions are recorded.

1 session

1 visit (in-person)

Experimental session

Subjects perform finger extension movements with and without assistance in different blocks.

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental sessions.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• End-effector assistance
• Exotendon assistance

Trial Overview The study tests two types of assistance during finger extension exercises: end-effector and exotendon assistance. It measures how these aids affect muscle coordination in chronic stroke survivors compared to healthy controls. Participants will be split into groups to try each method in varying sequences.

How Is the Trial Designed?

Group I: Exotendon assistance followed by end-effector assistance Experimental Treatment 2 Interventions

Group II: End-effector assistance followed by exotendon assistance Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

The Catholic University of America

Lead Sponsor

Trials

15

Recruited

2,700+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12250684/

Effectiveness of Robot-Assisted Gait Training in Stroke ... Subgroup analyses revealed that end-effector robotic systems yielded superior outcomes compared to exoskeletons, particularly in subacute stroke ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590109524001009

Efficacy of Robot-assisted Training on Upper Limb Motor ... The results of network meta-analysis showed that the best probability of improving upper limb motor function was end-effector robot-assisted therapy (EE-RAT)> ...

3. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01662-4

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.048183?doi=10.1161/STROKEAHA.124.048183

Effects of Robot-Assisted Therapy for Upper Limb ... Subgroup analyses showed that robotics had a significant effect on motor function recovery (FMA score) regardless of stroke stage (acute, ...

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

Effect of robot-assisted training for lower limb rehabilitation ... The results indicated that end-effector training was more effective than exoskeleton robots in improving lower limb motor function in stroke patients, with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12265130/

Upper limb robotic rehabilitation following stroke: a systematic ... The results suggest that robotic rehabilitation does not result in clinically meaningful improvement in either upper limb capacity or ADL performance.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2666459325000447

Functional and motoric outcome of AI-assisted stroke ... This pilot study investigated end-effector lower limb rehabilitation robot training effects in subacute stroke patients. MBI and MI, ≤ 3 months, 26, 63.04 ...

8. nature.com nature.com/articles/s41598-020-58630-2

Comparisons between end-effector and exoskeleton ... The present study aimed to directly compare EE and Exo robots in chronic stroke patients with moderate-to-severe upper limb impairment. This ...