Promoting Neuroplastic Changes of Patients With TBI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-85
SponsorUniversity of Maryland, Baltimore

About this trial

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-TBI including patients who are paralyzed with no motor output. The early acute TBI rehabilitation device will be evaluated in this clinical trial.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Motor relearning training with wearable ankle robot
  • Passive stretching with wearable ankle robot
  • Gamed-based active movement training with wearable ankle robot
  • Passive movement with limited wearable ankle robot
  • Active movement training with limited wearable ankle robot
  • Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot

Treatment groups

100 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Maryland, Baltimore

Lead sponsor

The University of Texas Health Science Center, Houston

Collaborator