RecruitingPhase 1Phase 2NCT06404268

Facilitating Neuroplastic Changes of Acute Stroke Survivors

Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia


Sponsor

University of Maryland, Baltimore

Enrollment

68 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This project will develop a wearable rehabilitation robot suitable for in-bed acute stage rehabilitation. It involves robot-guided motor relearning, passive and active motor-sensory rehabilitation early in the acute stage post-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.


Eligibility

Min Age: 30 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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
  • ≤Manual Muscle Testing (MMT)<=2
  • Age 30-85
  • Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

Exclusion Criteria8

  • 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

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Interventions

DEVICEMotor relearning training

Ankle motor control relearning training under real-time feedback

DEVICEPassive stretching

Passive stretching under intelligent robotic control

DEVICEGamed-based active movement training

Active movement training through movement games with robotic assistance

DEVICEPassive movement

Passive movement in the joint middle range of motion

DEVICEActive movement training

Active movement training without robotic assistance

DEVICEAnkle torque and motion measurement

Ankle torque and motion measurement with no real-time feedback


Locations(2)

University of Maryland Baltimore

Baltimore, Maryland, United States

UMROI

Baltimore, Maryland, United States

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NCT06404268


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