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Search / Trial NCT06465290

Promoting Neuroplastic Changes of Patients With TBI

Launched by UNIVERSITY OF MARYLAND, BALTIMORE · Jun 17, 2024

Trial Information

Current as of July 24, 2025

Not yet recruiting

Keywords

Traumatic Brain Injury (Tbi) Paraplegia Acute

ClinConnect Summary

This clinical trial is studying a new rehabilitation robot designed to help patients recover from traumatic brain injuries (TBI) while they are still in bed. The robot will assist with motor relearning and sensory rehabilitation to help patients regain movement, even if they are currently unable to move due to paralysis. The goal is to see how effective this device is in supporting recovery during the early stages after a brain injury.

To be eligible for this trial, participants must be between 30 and 85 years old and have experienced a first-time stroke that has affected one side of the body. They should also have some level of weakness or paralysis, specifically with their ankle movements. However, individuals who are not medically stable, have severe health issues, or cannot follow instructions due to cognitive difficulties will not be able to participate. If you join the trial, you can expect to use the rehabilitation robot as part of your recovery process, which aims to make rehabilitation easier and more effective during your recovery from a brain injury.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Acute first time unilateral hemispheric stroke (hemorrhagic or ischemic stroke, 24 hours after admission to 1 month post-stroke at the start of the proposed treatment)
  • Hemiplegia or hemiparesis
  • 0≤Manual Muscle Testing (MMT)\<=2
  • Age 30-85
  • Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion
  • Exclusion Criteria:
  • Medically not stable
  • Associated acute medical illness that interferes with ability to training and exercise
  • No impairment or very mild ankle impairment of ankle
  • Severe cardiovascular problems that interfere with ability to perform moderate movement exercises
  • Cognitive impairment or aphasia with inability to follow instructions
  • Severe pain in legs
  • Severe ankle contracture greater than 15° plantar flexion (when pushing ankle to dorsiflexion)
  • Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee

About University Of Maryland, Baltimore

The University of Maryland, Baltimore (UMB) is a leading academic institution dedicated to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical studies, UMB leverages its extensive resources and expertise across various disciplines, including medicine, pharmacy, nursing, and social work, to contribute to groundbreaking discoveries and improve patient outcomes. Committed to ethical research practices and collaboration, UMB fosters an environment that promotes the translation of scientific knowledge into real-world applications, ultimately enhancing the well-being of diverse populations.

Locations

Patients applied

0 patients applied

Trial Officials

Li-Qun Zhang

Principal Investigator

University of Maryland

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported