Promoting Neuroplastic Changes of Patients With TBI

Overview

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.

Detailed description

Early after TBI, patients often have significant sensorimotor impairment. There is heightened neural excitability, which may be used to facilitate recovery in the acute phase post stroke. However, there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy. The proposed randomized clinical trial using a wearable rehabilitation robot, muscle electromyography (EMG), and/or potentially brain electroencephalogram (EEG) signal seeks to provide early intensive sensorimotor training facilitated by real-time audiovisual and haptic feedback, intelligent stretching and sensory stimulation, active movement training through motivating movement games to promote neuroplasticity and reduce sensorimotor impairments. For acute TBI survivors who cannot generate any motor output yet, EMG or EEG may be used to detect the earliest re-emerging motor control signal and the robot can be used to provide demo and feedback of the intended movement.

Interventions

• Device Motor relearning training with wearable ankle robot
  Ankle motor control relearning training under real-time feedback
• Device Passive stretching with wearable ankle robot
  Passive stretching under intelligent robotic control
• Device Gamed-based active movement training with wearable ankle robot
  Active movement training through movement games with robotic assistance
• Device Passive movement with limited wearable ankle robot
  Passive movement in the joint middle range of motion
• Device Active movement training with limited wearable ankle robot
  Active movement training without robotic assistance
• Device Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot
  Ankle/Wrist torque and motion measurement with no real-time feedback

Primary outcome measures

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

Secondary outcome measures (6)

• Active range of motion (AROM) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Passive Range of Motion (PROM) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Strength of the ankle flexor-extensor muscle [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Modified Ashworth Scale (MAS) [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• Berg Balance Scale [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
• 10-meter Walk Test [Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Li-Qun Zhang — Baltimore

Publications

• Zhang C, Huang MZ, Kehs GJ, Braun RG, Cole JW, Zhang LQ. Intensive In-Bed Sensorimotor Rehabilitation of Early Subacute Stroke Survivors With Severe Hemiplegia Using a Wearable Robot. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2252-2259. doi: 10.1109/TNSRE.2021.3121204. Epub 2021 Nov 4. PMID 34665733
• Krakauer JW, Carmichael ST, Corbett D, Wittenberg GF. Getting neurorehabilitation right: what can be learned from animal models? Neurorehabil Neural Repair. 2012 Oct;26(8):923-31. doi: 10.1177/1545968312440745. Epub 2012 Mar 30. PMID 22466792
• Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5. PMID 21571152
• Nudo RJ, Milliken GW. Reorganization of movement representations in primary motor cortex following focal ischemic infarcts in adult squirrel monkeys. J Neurophysiol. 1996 May;75(5):2144-9. doi: 10.1152/jn.1996.75.5.2144. PMID 8734610
• Ren Y, Wu YN, Yang CY, Xu T, Harvey RL, Zhang LQ. Developing a Wearable Ankle Rehabilitation Robotic Device for in-Bed Acute Stroke Rehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2017 Jun;25(6):589-596. doi: 10.1109/TNSRE.2016.2584003. Epub 2016 Jun 22. PMID 27337720
• Sanger TD, Delgado MR, Gaebler-Spira D, Hallett M, Mink JW; Task Force on Childhood Motor Disorders. Classification and definition of disorders causing hypertonia in childhood. Pediatrics. 2003 Jan;111(1):e89-97. doi: 10.1542/peds.111.1.e89. PMID 12509602
• Selles RW, Li X, Lin F, Chung SG, Roth EJ, Zhang LQ. Feedback-controlled and programmed stretching of the ankle plantarflexors and dorsiflexors in stroke: effects of a 4-week intervention program. Arch Phys Med Rehabil. 2005 Dec;86(12):2330-6. doi: 10.1016/j.apmr.2005.07.305. PMID 16344031
• Sukal-Moulton T, Clancy T, Zhang LQ, Gaebler-Spira D. Clinical application of a robotic ankle training program for cerebral palsy compared to the research laboratory application: does it translate to practice? Arch Phys Med Rehabil. 2014 Aug;95(8):1433-40. doi: 10.1016/j.apmr.2014.04.010. Epub 2014 May 2. PMID 24792141

Identifiers

NCT: NCT06465290 · HP-00110703

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗