RecruitingPhase 1Phase 2NCT04550728

Hybrid Robot+FES Stroke Rehabilitation

Assessment Followed by Home-based Hybrid Robot + FES Rehabilitation Post-stroke

Sponsor

University of Maryland, Baltimore

Enrollment

60 participants

Start Date

Aug 1, 2021

Study Type

INTERVENTIONAL

Conditions

Stroke

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria4

Age 18-85;
Able to ambulate at least 10 meters without human assistance, with or without an assistive device
≥ 6 months post stroke;
having a caregiver to assist in training at home.

Exclusion Criteria6

having expressive and receptive aphasia;
an inability to follow multi-step commands;
enrolled in another lower limb rehabilitation program;
having severe pain in the paralyzed lower-limb;
\>30º ankle plantar flexion contracture;
Having implanted electronic device such as a pacemaker, spinal cord, or deep brain stimulator because FES may potentially interfere with their functions.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

COMBINATION_PRODUCTAnkle robot training group

Patients will be seated with the paretic foot strapped to the footplate the knee at full extension. The operator will set up and measure (using the robot) ankle passive DF and PF ROM limits. The robot training will include passive stretching, robot interactive game-based training, and cool-down stretching.

COMBINATION_PRODUCTAnkle robot training and functional electrical stimulation(FES) group

Patients will use the ankle robot device as the ankle training group. Also, water-based FES electrodes positioned inside a soft garment will be secured over the DF and PF muscles by wrapping the garment around the leg just below the knee joint. Stimulation intensity will be increased to maximal tolerance of each participant. Electrically induced contraction timing will be triggered by the ankle robot in synchrony with the ankle dorsi and plantar flexion movements.