NCT04309305Enrolling by invitationPhase 1
Robotic Exoskeleton Assisted Gait Post Stroke
Functional and Neurophysiological Effects of a Progressive Robot Assisted Gait Intervention Early Post Stroke
Source: ClinicalTrials.gov · Last updated 6 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The current investigation takes advantage of both a progressive and adaptive assist-as-needed massed practice and time-sensitive neuroplasticity through exoskeleton assisted walking in order to induce greater recovery-oriented CNS plasticity and consequent gains in more independent walking.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 10 Feb 2020
- Start date
- 30 Jan 2020
- Primary completion date
- 1 May 2026
- Lead sponsor
- Kessler Foundation
- Diseases
- Stroke
- NCT number
- NCT04309305
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 75
- From 30 Jan 2020 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any metal implants that are NOT MRI-compatible
Other illness
- Pre-existing condition that caused exercise intolerance.(Documented uncontrolled hypertension, coronary artery disease, cardiac arrhythmia, or congestive heart failure)
- Hospitalization for heart attack, heart surgery or acute heart failure within 3 months of enrollment in study.
- Severe cognitive or psychiatric problems as well as incontinence might be contraindications to start training with a RE.
- History of severe cardiac disease such as myocardial infarction, congestive heart failure
- Uncontrolled seizure disorder.
- Neuromuscular or neurological pathologies (e.g., Parkinson's disease, spinal cord injury, or traumatic brain injury with evidence of motor weakness and multiple sclerosis) that will interfere with neuromuscular function, ambulation, or limit the range of motion of the lower limbs
Other
- Any medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe spasticity).
- Skin issues that would prevent wearing the device.
- Uncontrolled spasticity or joint contracture that would interfere with walking in the RE and limits normal ROM during ambulation with assistive devices.
- Orthopedic pathologies or history that will interfere with ambulation or limit the ROM of the lower limbs (e.g., knee replacement, fixed contractures, inflammation)
Who the study is looking for
- Stroke survivors \< 4 weeks from most recent stroke.
- Age: 21- 80 years
- Unilateral hemiparesis
- Medical clearance by the Medical Director
- Be able to physically fit into the exoskeleton device.
- Have joint range of motion within normal functional limits for ambulation.
- Have sufficient strength to use the hemiwalker, cane or walker (etc. assistive device) while wearing the RE.
- Patient cognitive status and ability to communicate in English must be at a level consistent with that required to participate in standard motor rehabilitation, e.g. can follow directions.
- Adequate cognitive function to give informed consent, understand the training, instructions, use investigational devices and give adequate feedback.
- No history of injury or pathology to the unaffected limb.
- physically fit within the RE: Height below 60" or above 76" and weight above 220 lbs.
Age in the registry: 21 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kessler Foundation Coordinator of this site? Confirm its status | West Orange | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.