Hybrid Robot+FES Stroke Rehabilitation

University of Maryland Baltimore (UMB)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Stroke

Treatments: Combination Product: Ankle robot training group; Combination Product: Ankle robot training and functional electrical stimulation(FES) group

Study type: Interventional

Funder types: Other

Identifiers

NCT04550728

HP-00089895

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

FES+robot

Experimental group

Description:

Participants in this group will have FES during ankle robot training

Treatment:

Combination Product: Ankle robot training and functional electrical stimulation(FES) group

Robot

Active Comparator group

Description:

Participants in this group will have ankle robot training only

Treatment:

Combination Product: Ankle robot training group