Robot-Guided Therapy + FES for Stroke Rehabilitation

Overseen By Li-qun Zhang, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, Baltimore

Disqualifiers: Aphasia, Severe pain, Electronic implants, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rehabilitation approach for stroke survivors with movement and sensation issues. It combines a robot-guided ankle training device (Ankle Robot Training) with functional electrical stimulation (FES), which uses mild electrical pulses to help muscles move. Participants will use either the ankle robot alone or with FES to improve walking and movement abilities. The trial is mainly home-based, providing convenience for daily life. It suits those who had a stroke over six months ago, can walk at least 10 meters with or without a device, and have a caregiver to assist with home training. As an unphased trial, this study offers a unique opportunity to explore innovative rehabilitation methods in a flexible, home-based setting.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this robot-guided therapy and FES system is safe for stroke rehabilitation?

Research has shown that both robot-guided therapy and functional electrical stimulation (FES) aid stroke recovery. In earlier studies, robot-assisted training improved joint movement and muscle strength without major safety concerns. Patients generally adapted well to the robot and experienced enhanced movement abilities.

A review of 25 studies found FES beneficial for stroke recovery. FES activates muscles and is considered safe for individuals with neurological issues. It has been successfully used in various rehabilitation settings, with few reports of serious side effects.

Both treatments are generally well-tolerated, with evidence indicating improvements in muscle function and movement. While specific side effects are not detailed in the sources, the absence of reported safety issues suggests these treatments are generally safe when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using robot-guided therapy combined with Functional Electrical Stimulation (FES) for stroke rehabilitation because it offers a unique, high-tech approach to recovery. Unlike traditional physical therapy, which relies on manual exercises, this method uses an ankle robot to guide movements precisely and consistently. The addition of FES further enhances muscle activation by sending electrical impulses, potentially accelerating recovery and improving outcomes. This combination could lead to more effective and faster rehabilitation for stroke survivors, offering hope for better mobility and quality of life.

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

Research has shown that combining robot-guided therapy with functional electrical stimulation (FES) can aid stroke recovery. In this trial, one group of participants will receive both FES and ankle robot training, while another group will receive only ankle robot training. Studies have found that ankle robot training can enhance movement, increase joint flexibility, and strengthen muscles in stroke patients. FES activates muscles, improving movement in individuals with nerve-related conditions. By merging these methods, the approach aims to enhance movement and reduce muscle tightness. Evidence suggests this combination could significantly improve movement and decrease joint stiffness in stroke survivors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for stroke survivors aged 18-85 who can walk at least 10 meters without help, have a caregiver to assist with home training, and are more than 6 months post-stroke. It's not suitable for those with severe lower-limb pain, communication difficulties due to aphasia, inability to follow instructions, current participation in another leg rehab program, significant ankle contracture or implanted electronic devices like pacemakers.

Inclusion Criteria

I have someone to help me with my treatment at home.

I can walk 10 meters by myself, with or without help like a cane.

It has been over 6 months since my stroke.

Exclusion Criteria

I experience severe pain in my paralyzed lower limb.

I have trouble understanding and expressing spoken words.

I struggle to follow multi-step instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive home-based hybrid robot and FES rehabilitation for sensorimotor and locomotion impairments post-stroke

12 weeks

Primarily home-based with periodic assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ankle Robot Training
• Functional Electrical Stimulation (FES)

Trial Overview The study tests a new home-based rehabilitation system combining an ankle robot and functional electrical stimulation (FES) against the ankle robot alone. The goal is to see if this hybrid approach better aids motor recovery and walking ability after a stroke compared to just robotic assistance.

How Is the Trial Designed?

Group I: FES+robot Experimental Treatment 1 Intervention

Participants in this group will have FES during ankle robot training

Group II: Robot Active Control 1 Intervention

Participants in this group will have ankle robot training only

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials

729

Recruited

540,000+

Published Research Related to This Trial

The use of an electromechanical gait trainer combined with functional electrical stimulation (FES) in a 4-week program led to significant improvements in gait performance and functional activities for two patients with acute ischemic stroke.

Both patients maintained their improvements in various measures of mobility and balance, such as the Barthel Index and Berg Balance Scale, even 6 months after the intervention, indicating long-term benefits of this rehabilitation approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. Tong, RK., Ng, MF., Li, LS., et al.[2016]

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]

The developed feedback-controlled functional electrical stimulation (FES) system provides real-time muscle stimulation for hemiplegic patients, helping to prevent drop-foot and quadriceps weakness during gait training.

The FES system uses tilt sensors and footswitches to automatically adjust stimulation parameters, ensuring optimal support for patients as they walk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the tilt sensors feedback controlled FES for hemiplegia. Chen, YL., Shih, YY., Chen, WL., et al.[2020]

In a study involving nine healthy participants, using functional electrical stimulation (FES) while walking with a robotic exoskeleton significantly reduced the torque required at the hip and knee joints, indicating improved efficiency in movement.

The combination of the rehabilitation robot and FES shows promise for assisting paraplegics with varying levels of muscle weakness, potentially enhancing their rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Gait Rehabilitation Robot Using an Exoskeleton and Functional Electrical Stimulation: Validation in a Pseudo-paraplegic Model. Inoue, J., Kimura, R., Shimada, Y., et al.[2022]

In a study of 20 chronic stroke patients, those who received robot-assisted gait training combined with functional electrical stimulation showed significant improvements in step length and knee extension compared to those who only received gait training.

Both groups demonstrated improvements in overall mobility and balance, as measured by the Modified Motor Assessment Scale, Timed Up-and-Go Test, and Berg Balance Scale, indicating that the combined therapy is effective and safe for enhancing locomotor recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Robot-assisted Gait Training Combined with Functional Electrical Stimulation on Recovery of Locomotor Mobility in Chronic Stroke Patients: A Randomized Controlled Trial. Bae, YH., Ko, YJ., Chang, WH., et al.[2020]

The novel functional electrical stimulation (FES) system developed in the HYPER project aims to enhance rehabilitation for patients with motor impairments due to cerebrovascular accidents or spinal cord injuries by utilizing existing muscle activity.

This portable FES system features advanced electrostimulator circuits and improved channel switching, making it more effective for controlling muscle movements and supporting the development of neurorobots and neuroprosthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing functional electrical stimulation for emerging rehabilitation robotics in the framework of HYPER project. Brunetti, F., Garay, Á., Moreno, JC., et al.[2016]

The study evaluates a new robotic gait-training device that combines saddle-seat support with functional electrical stimulation (FES) to improve walking in patients with neuromuscular diseases, showing promise in restoring voluntary control of locomotion.

Results indicate that the saddle-seat support allows for a more natural posture and effectively supports key gait functions, especially at slower walking speeds, compared to traditional harness-type support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of partial body-weight support and functional electrical stimulation on gait characteristics during treadmill locomotion: Pros and cons of saddle-seat-type body-weight support. Kataoka, N., Hirai, H., Hamilton, T., et al.[2018]

The study focuses on developing a specialized ankle neuroprosthesis (NP) that integrates with hybrid rehabilitation robotics to enhance motor function recovery in individuals with impaired ankle movement.

This research highlights the potential of using functional electrical stimulation (FES) to control both ankle flexion and extension, which could lead to improved gait patterns in patients with paretic limbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards an ankle neuroprosthesis for hybrid robotics: Concepts and current sources for functional electrical stimulation. Casco, S., Fuster, I., Galeano, R., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04550728

NCT04550728 | Hybrid Robot+FES Stroke Rehabilitation The robot training will include passive stretching, robot interactive game-based training, and cool-down stretching. What is the study measuring? Primary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10789316/

Ankle rehabilitation robot training for stroke patients with ... Each session lasted 20 minutes and all subjects were trained 5 days a week for 3 weeks. RESULTS: After 3 weeks of treatment, all groups showed an improvement in ...

3. clinicaltrials.gov clinicaltrials.gov/ct2/show/results/NCT04550728

NCT04550728 | Hybrid Robot+FES Stroke Rehabilitation A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0010482524009247

A robot-based hybrid lower limb system for Assist-As ... This study aims to present the technical validation and demonstrate the feasibility of a rehabilitation system providing lower limb movement assistance to ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11123305/

Effects of Rehabilitation Robot Training on Physical ... Based on these results, rehabilitation robotic training resulted in significant improvements in physical function, functional recovery, and ...

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/252157

Hybrid Robot+FES Stroke Rehabilitation Ankle robot training and functional electrical stimulation(FES) group. Patients will use the ankle robot device as the ankle training group.

7. trialx.com trialx.com/clinical-trials/listings/231637/hybrid-robotfes-stroke-rehablitation/

Hybrid Robot+FES Stroke Rehablitation Functional electrical stimulation (FES), has been shown its advantage to activate the peripheral muscles for people with neurological conditions ...