Robotic Training + FES vs Robotic Training Alone for Stroke Recovery

Overseen By Sanjana Rao

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Must not be taking: Botox

Disqualifiers: Pain, Arthritis, Neurological disorders, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether combining Functional Electrical Stimulation (FES) with robotic training improves arm movement more effectively than robotic training alone for stroke survivors. The focus is on enhancing arm function post-stroke. Individuals who had a stroke over six months ago and can move their arm forward by about 3 inches may qualify. As an unphased trial, this study provides a unique opportunity to explore innovative rehabilitation methods that could enhance recovery.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are receiving Botox injections, you must not have had them within the last 3 months.

What prior data suggests that this hybrid rehabilitation program is safe for stroke recovery?

Research has shown that combining robotic training with functional electrical stimulation (FES) is safe and well-tolerated for people recovering from strokes. This approach uses electrical signals to activate muscles without causing excessive fatigue, making it suitable for stroke patients. A review of 25 studies supports these findings, demonstrating positive results in improving arm movement for stroke patients using FES.

Although specific safety data for robotic training alone is not provided, its use in stroke rehabilitation suggests it is generally considered safe. Both treatments aim to improve movement and strength in the arms after a stroke. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine cutting-edge technology with traditional rehabilitation methods to potentially enhance stroke recovery. The Hybrid multi-muscle FES+Robot approach is unique because it synchronizes Functional Electrical Stimulation (FES) with robotic-assisted movement. This combination aims to improve muscle coordination and strength by triggering muscle contractions at the same time as robotic movements, which could lead to more effective rehabilitation. On the other hand, the Robot only method focuses on multi-directional reach movements, leveraging robotic precision to retrain upper extremity function. These methods could offer more personalized and effective recovery options compared to conventional therapies like physical therapy alone.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

Research has shown that using Functional Electrical Stimulation (FES) with robotic training can aid stroke recovery. In this trial, participants in the "Hybrid multi-muscle FES+Robot" arm will receive this combined approach. A review of 25 studies demonstrated improved arm and hand function after a stroke with this method. Another study found that combining robotic devices with FES led to better results in arm and hand rehabilitation. This combined approach may be more effective than using robotic training alone, as participants in the "Robot only" arm will receive, because it enhances muscle coordination. Early findings suggest that coordinating muscle stimulation with robotic movement could accelerate and improve recovery for stroke patients. ^{6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 22-85 who've had a stroke over 6 months ago and can reach forward about 3 inches with their arm. It's not suitable for those with implants like pacemakers, other upper limb issues, intolerance to electrical stimulation, recent Botox injections in the area, or severe elbow contracture.

Inclusion Criteria

I had a stroke more than 6 months ago.

I am between 22 and 85 years old.

I can reach forward with my arm about 3 inches.

Exclusion Criteria

My elbow can't straighten beyond 150 degrees.

I have received Botox injections in the last 3 months.

I have conditions like pain, arthritis, or nerve issues in my arms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 18 sessions of 60-minute upper extremity training over 6 weeks, either with Hybrid multi-muscle FES+Robot or Robot only

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Multi-muscle FES
• REACH robotic training
• Robot only

Trial Overview

The study tests if combining Functional Electrical Stimulation (FES) with robotic training improves arm function after stroke better than robotic training alone. Participants will be divided into two groups: one receiving both FES and robot-assisted therapy, and the other only robot-assisted therapy.

How Is the Trial Designed?

Group I: Hybrid multi-muscle FES+Robot Experimental Treatment 1 Intervention

Participants will be receive hybrid upper extremity training involving the combination of REACH robotic device and multi-muscle FES. Water based electrodes will be positioned on the Triceps, Anconeus, wrist and finger extensors. Stimulation intensity of FES will be set at the participants tolerance level. The FES induced muscle contraction timing will be triggered in synchrony with the robotic movement. The training will be a multi-directional reach movement and hand opening re-training.

Group II: Robot only Active Control 1 Intervention

Participants will receive upper extremity training with the REACH robotic device. The training will be a multi-directional reach movement re-training.

Multi-muscle FES is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Muscle spasticity
• Neurological disorders

Approved in United States as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Muscle spasticity
• Neurological disorders

Approved in Canada as Functional Electrical Stimulation for:

• Stroke rehabilitation
• Muscle spasticity
• Neurological disorders

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

The study demonstrated that a motorized cycling system combined with functional electrical stimulation (FES) is safe and well-tolerated by 10 subjects with chronic hemiplegia, with no adverse reactions reported during the 8-week training program.

Participants showed significant improvements in physical performance, including a 24.6% reduction in time for the 'get up and go' test and a 25% increase in gait velocity, indicating enhanced mobility and strength after the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensive training of subjects with chronic hemiparesis on a motorized cycle combined with functional electrical stimulation (FES): a feasibility and safety study. Alon, G., Conroy, VM., Donner, TW.[2011]

Functional electrical stimulation (FES) is an innovative rehabilitation technique that allows paralyzed patients to regain some control over their extremities by using small electronic stimulators to activate their muscles.

Recent advancements in FES include both single- and multi-channel stimulation methods, showing promise in improving functionality in both the legs and upper extremities of patients with paralysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional electrical stimulation of the extremities: part 1. Kralj, A., Vodovnik, L.[2019]

The study tested a hybrid robotic-FES system on eight healthy subjects, revealing that responses to repetitive leg-press exercises varied significantly, with some subjects showing increased exertion while others showed fatigue.

These findings highlight the need for future robotic rehabilitation systems to adapt to individual variations in exertion and fatigue to ensure both efficacy and safety during rehabilitation for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increase and Decrease in Velocity and Force During Exercise with a Hybrid Robotic-FES Rehabilitation System. Leerskov, KS., Dosen, S., Spaich, EG., et al.[2022]

Combining functional electrical stimulation (FES) with robotic assistance significantly improves tracking performance in wrist movements compared to using FES alone, indicating that the combination enhances recovery after stroke.

Participants reported lower mental demand and experienced less muscle fatigue when using robotic assistance, suggesting that this combination allows for longer and more engaging training sessions than FES alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid Robotic and Electrical Stimulation Assistance Can Enhance Performance and Reduce Mental Demand. Cazenave, L., Einenkel, M., Yurkewich, A., et al.[2023]

High-intensity functional electric stimulation (FES)-assisted exercise therapy (FES-ET) significantly improved motor function in stroke survivors, as measured by the Wolf Motor Function Test (WMFT), compared to low-intensity FES-ET, with a notable effect size of 0.95.

Despite the improvements in objective measures of motor function, self-assessments of motor activity (Motor Activity Log) and overall function (Fugl-Meyer Assessment) did not show significant differences, raising questions about the clinical relevance of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Kowalczewski, J., Gritsenko, V., Ashworth, N., et al.[2016]

A study involving 72 stroke patients demonstrated that training with the RETRAINER robotic system, combined with Functional Electrical Stimulation, significantly improved arm function and dexterity compared to advanced conventional therapy over a 9-week period.

The RETRAINER group showed a notable improvement in the Action Research Arm Test, with a between-group change of 11.5 points immediately after the intervention, increasing to 13.6 points one month later, indicating lasting benefits from this hybrid training approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Robotic System with EMG-Triggered Functional Eletrical Stimulation for Restoring Arm Functions in Stroke Survivors. Ambrosini, E., Gasperini, G., Zajc, J., et al.[2021]

The FES-robot system, which uses functional electrical stimulation controlled by the user's motor intention, significantly improved wrist and finger motor functions in five hemiplegic subjects after 20 training sessions, as indicated by increased scores in the Fugl-Meyer Assessment and Action Research Arm Test (P < 0.05).

Compared to previous studies that used only interactive robot-assisted training, the addition of FES led to better muscle coordination and functional improvements in the upper limb, highlighting the efficacy of this combined approach for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of functional electrical stimulation (FES)-robot assisted wrist training on persons after stroke. Hu, XL., Tong, KY., Li, R., et al.[2020]

The study tested the feasibility of combining functional electrical stimulation with intramuscular electrodes (FES-IM) and gait robotics in six stroke survivors, showing that the integration of these technologies is practical for rehabilitation.

Each technology has its own strengths and weaknesses, highlighting the importance of accurately identifying gait deficits to create a targeted treatment plan for effective rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. McCabe, JP., Dohring, ME., Marsolais, EB., et al.[2019]

Functional Electrical Stimulation (FES) effectively restores controlled muscle contractions and limb function in patients with severe upper motor neuron lesions, particularly benefiting spinal cord injury patients.

To enhance patient acceptance and usability, future advancements in electrode technology and the development of 'close-loop' systems for better control and activation are necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of functional electrical stimulation. Kumar, VP., Lau, HK., Liu, J., et al.[2020]

Functional Electrical Stimulation (FES) has been used since the 1970s to help regain or support lost body functions through electrically induced muscle contractions, but many methods are still not widely used in clinical settings.

Collaboration among patients, clinicians, therapists, and engineers is essential to improve FES technology and its application, as understanding different perspectives can help address current limitations and guide future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Vienna FES Interview Protocol - A mixed-methods protocol to elucidate the opinions of various individuals responsible for the provision of FES exercise. Taylor, MJ., Fornusek, C., Ruys, AJ., et al.[2020]

In a study involving 39 chronic stroke survivors, all treatment groups (robotics plus motor learning, functional electrical stimulation plus motor learning, and motor learning alone) showed significant improvements in upper-limb function and coordination, indicating that intensive therapy can be beneficial regardless of the specific method used.

No significant differences were found between the treatment groups, suggesting that while all methods are effective, the choice of intervention may be flexible without compromising patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of robotics, functional electrical stimulation, and motor learning methods for treatment of persistent upper extremity dysfunction after stroke: a randomized controlled trial. McCabe, J., Monkiewicz, M., Holcomb, J., et al.[2016]

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