Facilitating Neuroplastic Changes of Acute Stroke Survivors

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT06404268
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Motor relearning training — DEVICE
    Ankle motor control relearning training under real-time feedback
  • Passive stretching — DEVICE
    Passive stretching under intelligent robotic control
  • Gamed-based active movement training — DEVICE
    Active movement training through movement games with robotic assistance
  • Passive movement — DEVICE
    Passive movement in the joint middle range of motion
  • Active movement training — DEVICE
    Active movement training without robotic assistance
  • Ankle torque and motion measurement — DEVICE
    Ankle torque and motion measurement with no real-time feedback

Study Details

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.

Key Dates

Start date
Jun 1, 2025
Status verified
Jul 2025
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Study group - Wearable ankle robot rehab
    Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance
  • Active Comparator: Control group - Limited wearable ankle robot rehab
    The same wearable robot used by the study group will be used for the control group but in a limited way: no motor relearning training under real-time feedback; passive movement in the joint middle range of motion instead of passive stretching; active movement training with no robotic assistance

Primary Outcome Measure

Fugl-Meyer Lower Extremity (FMLE) [ Time Frame: At the beginning and end of 3-week training, and 1 month after the treatment ends] ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
UMROIBaltimoreMaryland21207
Dali Xu
Peiwen Fu
University of Maryland BaltimoreBaltimoreMaryland21201
Dali Xu, PhD
Peiwen Fu, BS

Find similar trials in Baltimore, MD

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
UMROI· Baltimore, MDUniversity of Maryland Baltimore· Baltimore, MD

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