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RECRUITING
NCT04550728
PHASE1/PHASE2

Hybrid Robot+FES Stroke Rehabilitation

Sponsor: University of Maryland, Baltimore

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2021-08-01

Completion Date

2026-12-31

Last Updated

2025-12-18

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

Ankle 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_PRODUCT

Ankle 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.

Locations (1)

University of Maryland School of Medicine

Baltimore, Maryland, United States