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

Trial Summary

What is the purpose of this trial?

The investigators have developed a novel robot-guided stretching under intelligent control and combine it with active movement training, which helped increase joint ROM, reduce spasticity and joint stiffness, increase muscle force output, and improve locomotion. However, for stroke survivors with sensorimotor impairment, their peripheral muscle may not sufficiently be recruited. Functional electrical stimulation (FES), has been shown its advantage to activate the peripheral muscles for people with neurological conditions. The investigators thus make a hybrid robot-FES rehabilitation system, combining the advantage of robot and FES technologies for stroke motor recovery. The investigators further would like to translate the technologies from lab to home-based training. Thus, the investigators will conduct a randomized, controlled, primarily home-based clinical trial using an ankle robot alone or combined with functional electrical stimulation (FES) to treat sensorimotor and locomotion impairments post-stroke.

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 data supports the effectiveness of the treatment Robot-Guided Therapy + FES for Stroke Rehabilitation?

Research shows that combining robot-assisted gait training with functional electrical stimulation (FES) can improve walking ability and balance in stroke patients. Studies found that this combination helps patients recover better than using robot-assisted training alone, as it encourages active participation and enhances movement control. ^{1 2 3 4 5}

Is Robot-Guided Therapy combined with Functional Electrical Stimulation (FES) safe for stroke rehabilitation?

Research indicates that combining robot-assisted therapy with functional electrical stimulation (FES) for stroke rehabilitation is generally safe, as studies have shown improvements in mobility without adverse effects. ^{1 2 3 4 6}

How is the Robot-Guided Therapy + FES treatment for stroke rehabilitation different from other treatments?

This treatment is unique because it combines robot-guided therapy with functional electrical stimulation (FES) to enhance ankle movement and gait recovery after a stroke. The use of robotics and FES together aims to improve motor function more effectively by providing both mechanical support and electrical stimulation to the muscles, which is not typically offered in standard stroke rehabilitation therapies. ^{1 2 3 7 8}

Eligibility Criteria

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 am between 18 and 85 years old.

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. [2019]

2. Japan pubmed.ncbi.nlm.nih.gov

Development of a Gait Rehabilitation Robot Using an Exoskeleton and Functional Electrical Stimulation: Validation in a Pseudo-paraplegic Model. [2022]

3. United States 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. [2018]

4. Japan 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. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Gait training of patients after stroke using an electromechanical gait trainer combined with simultaneous functional electrical stimulation. [2016]

6. United States pubmed.ncbi.nlm.nih.gov

Clinical evaluation of the tilt sensors feedback controlled FES for hemiplegia. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Enhancing functional electrical stimulation for emerging rehabilitation robotics in the framework of HYPER project. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Towards an ankle neuroprosthesis for hybrid robotics: Concepts and current sources for functional electrical stimulation. [2018]