Robot-Guided Therapy + FES for Stroke Rehabilitation

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Maryland, Baltimore

Disqualifiers: Aphasia, Severe pain, Electronic implants, others

No Placebo Group

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.

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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.

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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.

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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.

Trial 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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Maryland School of Medicine Baltimore, MD

Who Is Running the Clinical Trial?

University of Maryland, Baltimore Lead Sponsor

References

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

Feasibility of combining gait robot and multichannel functional electrical stimulation with intramuscular electrodes. [2019] After stroke rehabilitation, many survivors of stroke exhibit persistent gait deficits. In previous work, we demonstrated significant gains in gait kinematics for survivors of chronic stroke using multichannel functional electrical stimulation with intramuscular electrodes (FES-IM). For this study, we tested the feasibility of combining FES-IM and gait robot technologies for treating persistent gait deficits after stroke. Six subjects, >or= 6 months after stroke, received 30-minute intervention sessions of combined FES-IM and gait robotics 4 days a week for 12 weeks. Feasibility was assessed according to three factors: (1) performance of the interface of the two technologies during intervention sessions, (2) clinicians' success in using two technologies simultaneously, and (3) subject satisfaction. FES-IM system hardware and software design features combined with the gait robot technology proved feasible to use. Each technology alone provided unique advantages and disadvantages of gait practice characteristics. Because of the unique advantages and disadvantages of each technology, gait deficits need to be accurately identified and a judicious treatment plan properly targeted before FES-IM, a gait robot, or both combined are selected.

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] We have developed a robot for gait rehabilitation of paraplegics for use in combination with functional electrical stimulation (FES). The purpose of this study was to verify whether the robot-derived torque can be reduced by using FES in a healthy-person pseudo-paraplegic model.

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] Robotic therapy for rehabilitation of the lower extremity is currently in its early stage of development. Aiming at exploring an efficacious intervention for gait rehabilitation, we investigate the characteristics of an end-effector gait-training device that combines saddle-seat-type body-weight-supported treadmill training with functional electrical stimulation (FES). This is a task-oriented approach to restoring voluntary control of locomotion in patients with neuromuscular diseases. We evaluate the differences between walking with saddle-seat-type support and with harness-type support, in terms of personal preference, the preferred walking speed, profiles of kinematics and ground reaction force, and the effectiveness of FES. The results indicate that the proposed gait-training device maintains subjects in a natural posture and supports important gait functions such as hip extension and ankle push-off effectively, in particular, at slow walking speed.

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] [Purpose] The purpose of the present study was to investigate the effects of robot-assisted gait training combined with functional electrical stimulation on locomotor recovery in patients with chronic stroke. [Subjects] The 20 subjects were randomly assigned into either an experimental group (n = 10) that received a combination of robot-assisted gait training and functional electrical stimulation on the ankle dorsiflexor of the affected side or a control group (n = 10) that received robot-assisted gait training only. [Methods] Both groups received the respective therapies for 30 min/day, 3 days/week for 5 weeks. The outcome was measured using the Modified Motor Assessment Scale (MMAS), Timed Up-and-Go Test (TUG), Berg Balance Scale (BBS), and gait parameters through gait analysis (Vicon 370 motion analysis system, Oxford Metrics Ltd., Oxford, UK). All the variables were measured before and after training. [Results] Step length and maximal knee extension were significantly greater than those before training in the experimental group only. Maximal Knee flexion showed a significant difference between the experimental and control groups. The MMAS, BBS, and TUG scores improved significantly after training compared with before training in both groups. [Conclusion] We suggest that the combination of robot-assisted gait training and functional electrical stimulation encourages patients to actively participate in training because it facilitates locomotor recovery without the risk of adverse effects.

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] This case report describes the implementation of gait training intervention that used an electromechanical gait trainer with simultaneous functional electrical stimulation (FES) for 2 patients with acute ischemic stroke.

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

Clinical evaluation of the tilt sensors feedback controlled FES for hemiplegia. [2020] A feedback controlled functional electrical stimulation (FES) system is developed to provide the hemiplegic patients a real-time stimulation to their muscles to prevent the drop-foot and the quadriceps weakness from happening during gait training. The FES is controlled by tilt sensors (t.s.) and triggered by footswitches (f) with real-time feedback. As the FES receives the signals from these sensors, it adjusts and outputs an optimum set of stimulation parameters automatically.

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

Enhancing functional electrical stimulation for emerging rehabilitation robotics in the framework of HYPER project. [2016] This paper presents the development of a novel functional electrical stimulation (FES) system. New approaches in emerging rehabilitation robotics propose the use of residual muscular activity or limbs movements during the rehabilitation process of neuromotor. More ambitious projects propose the use of FES systems to restore or compensate motor capabilities by controlling existing muscles or subject limbs. These emerging approaches require more sophisticated FES devices in terms of channels, signals controls and portability. In the framework of HYPER project, such devices are being developed to support the main objective of the project: the development of neurorobots and neuroprosthetics to restore functional motor capabilities in patients who suffered cerebrovascular accidents or spinal cord injury. The presented portable FES system includes novel elec-trostimulator circuits and improved channel switching capacities to enable emerging approaches in rehabilitation robotics.

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

Towards an ankle neuroprosthesis for hybrid robotics: Concepts and current sources for functional electrical stimulation. [2018] Hybrid rehabilitation robotics combine neuro-prosthetic devices (close-loop functional electrical stimulation systems) and traditional robotic structures and actuators to explore better therapies and promote a more efficient motor function recovery or compensation. Although hybrid robotics and ankle neuroprostheses (NPs) have been widely developed over the last years, there are just few studies on the use of NPs to electrically control both ankle flexion and extension to promote ankle recovery and improved gait patterns in paretic limbs. The aim of this work is to develop an ankle NP specifically designed to work in the field of hybrid robotics. This article presents early steps towards this goal and makes a brief review about motor NPs and Functional Electrical Stimulation (FES) principles and most common devices used to aid the ankle functioning during the gait cycle. It also shows a current sources analysis done in this framework, in order to choose the best one for this intended application.