Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
90

Summary

Conditions
Acute Stroke
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

The study will investigate an early intensive rehabilitation in acute stroke for motor relearning, reducing ankle impairments and improving balance and mobility/locomotion functions. The acute stroke survivor will be randomly placed into two groups. Subjects in the Study group will receive robot-aid...

The study will investigate an early intensive rehabilitation in acute stroke for motor relearning, reducing ankle impairments and improving balance and mobility/locomotion functions. The acute stroke survivor will be randomly placed into two groups. Subjects in the Study group will receive robot-aided motor relearning under real-time feedback, stretching under intelligent control, sensory stimulation, and active movement training with interactive games. Subjects in the Control group will receive passive movement in the middle ROM without intelligent stretching and active movement training without robotic guidance. For both groups, the therapeutic training will be conducted during 5 hourly sessions (including breaks/transitions between tasks) each week over about 3-week hospital stay. Both groups will also receive the standard of care in the hospital and rehabilitation service. Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical, neuromuscular and clinical outcome measures. Carry-over effects will be further evaluated 1 month after the treatment ends. Aim 1: To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion (ROM), flexor-extensor muscle strength, joint stiffness, proprioception and reflex excitability, and compare these measures between the two groups. The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot. Hypothesis 1: Robot-guided motor relearning, stretching and active movement training (Study group) will improve the biomechanical and neuromuscular outcome measures more than those of the Control group. Aim 2: To evaluate the clinical outcome measures as defined by Fugl-Meyer score (lower extremity), modified Ashworth scale, Berg balance scale, 10 meter walk test, and to compare between the Study and Control groups. Hypothesis 2: The Study group will improve the clinical outcome measures more than the Control group.

Tracking Information

NCT #
NCT02369770
Collaborators
  • Northwestern University
  • Northwestern Memorial Hospital
Investigators
Principal Investigator: Li-Qun Zhang, Ph.D. University of Maryland, Baltimore