No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 85
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of Maryland, Baltimore · Other
Who this trial is looking for
This trial is looking for people who have had a stroke and need help with movement. Participants will use a special robotic device, sometimes combined with electrical stimulation, to aid in their recovery at home.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 85 years old.
I can walk at least 10 meters by myself or with a device.
I am at least 6 months post stroke.
I have a caregiver to help me with training at home.
You may not be able to join if
I have trouble speaking or understanding language.
I cannot follow multi-step instructions.
I am in another lower limb rehabilitation program.
I have severe pain in my paralyzed leg.
I have more than 30 degrees of ankle contracture.
I have a pacemaker, spinal cord stimulator, or deep brain stimulator.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 electri…
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.
Trial Locations
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Eligibility Criteria
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 follo…
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.
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