Traumatic Brain InjuryNCT06465290
Promoting Neuroplastic Changes of Patients With TBI
A study testing Motor relearning training with wearable ankle robot, Passive stretching with wearable ankle robot and Gamed-based active movement training with wearable ankle robot in people with Traumatic Brain Injury, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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-TBI including patients who are paralyzed with no motor output. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Motor relearning training with wearable ankle robot, Passive stretching with wearable ankle robot and Gamed-based active movement training with wearable ankle robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Li-Qun Zhang
Baltimore, Maryland, 21201
Li-Qun Zhang, PhD, 4107062145, l-zhang@som.umaryland.edu
About this study
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.
Read the 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.
- Conditions
- Traumatic Brain Injury
- Being tested
- 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
- Keywords
- Traumatic Brain Injury (TBI), Paraplegia, Acute
- Medical subject headings
- Brain Injuries, Traumatic, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor relearning training with wearable ankle robotDevice
Ankle motor control relearning training under real-time feedback
Passive stretching with wearable ankle robotDevice
Passive stretching under intelligent robotic control
Gamed-based active movement training with wearable ankle robotDevice
Active movement training through movement games with robotic assistance
Passive movement with limited wearable ankle robotDevice
Passive movement in the joint middle range of motion
Active movement training with limited wearable ankle robotDevice
Active movement training without robotic assistance
Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robotDevice
Ankle/Wrist torque and motion measurement with no real-time feedback
| Study group | Role | What they receive |
|---|---|---|
| Study group - Intensive ankle/hand robot rehab | Experimental | Ankle/Hand robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance Receives: Device: Motor relearning training with wearable ankle robot; Device: Passive stretching with wearable ankle robot; Device: Gamed-based active movement training with wearable ankle robot |
| Control group - Mild ankle/hand robot rehab | Active comparator | 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 Receives: Device: Passive movement with limited wearable ankle robot; Device: Active movement training with limited wearable ankle robot; Device: Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Lower Extremity (FMLE)
The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends]
Secondary outcomes (6)
Active range of motion (AROM)
AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle.
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends
Passive Range of Motion (PROM)
Passive Range of Motion PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends
Strength of the ankle flexor-extensor muscle
Strength of the ankle flexor-extensor muscle will be measured in Newtons
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension.
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends
Berg Balance Scale
The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. The Berg balance scale ranges from 0 to 56. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends
10-meter Walk Test
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance at the beginning and end of 3-week training, and 1 month after the treatment ends. It can be employed to determine functional mobility and gait function.
Measured: At the beginning and end of 3-week training, and 1 month after the treatment ends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start16 Jul 2026
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial with the study group and control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li-Qun Zhang, University of Maryland, Baltimore
- Investigators
- Li-Qun Zhang, Principal investigator, University of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465290
- Sponsor's protocol ID
- HP-00110703
- Status last verified
- Jul 2026
- First submitted
- 24 May 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 34665733Krakauer 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.
PubMed 22466792Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
PubMed 21571152Nudo 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.
PubMed 8734610Ren 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.
PubMed 27337720Sanger 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.
PubMed 12509602Selles 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.
PubMed 16344031Sukal-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.
PubMed 24792141Waldman G, Yang CY, Ren Y, Liu L, Guo X, Harvey RL, Roth EJ, Zhang LQ. Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. NeuroRehabilitation. 2013;32(3):625-34. doi: 10.3233/NRE-130885.
PubMed 23648617Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22.
PubMed 21343525Wu YN, Ren Y, Goldsmith A, Gaebler D, Liu SQ, Zhang LQ. Characterization of spasticity in cerebral palsy: dependence of catch angle on velocity. Dev Med Child Neurol. 2010 Jun;52(6):563-9. doi: 10.1111/j.1469-8749.2009.03602.x. Epub 2010 Jan 28.
PubMed 20132137Xerri C, Merzenich MM, Peterson BE, Jenkins W. Plasticity of primary somatosensory cortex paralleling sensorimotor skill recovery from stroke in adult monkeys. J Neurophysiol. 1998 Apr;79(4):2119-48. doi: 10.1152/jn.1998.79.4.2119.
PubMed 9535973Yang CY, Guo X, Ren Y, Kang SH, Zhang LQ. Position-dependent, hyperexcitable patellar reflex dynamics in chronic stroke. Arch Phys Med Rehabil. 2013 Feb;94(2):391-400. doi: 10.1016/j.apmr.2012.09.029. Epub 2012 Oct 11.
PubMed 23063880Zhang LQ, Chung SG, Ren Y, Liu L, Roth EJ, Rymer WZ. Simultaneous characterizations of reflex and nonreflex dynamic and static changes in spastic hemiparesis. J Neurophysiol. 2013 Jul;110(2):418-30. doi: 10.1152/jn.00573.2012. Epub 2013 May 1.
PubMed 23636726Zhang LQ, Rymer WZ. Reflex and intrinsic changes induced by fatigue of human elbow extensor muscles. J Neurophysiol. 2001 Sep;86(3):1086-94. doi: 10.1152/jn.2001.86.3.1086.
PubMed 11535659
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Neuroplastic Changes of Patients With TBI
- ClinicalTrials.gov ID
- NCT06465290
- Acronym / sponsor ID
- HP-00110703
- Conditions
- Traumatic Brain Injury
- Keywords
- Traumatic Brain Injury (TBI), Paraplegia, Acute
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized clinical trial with the study group and control group
| Arm | Type | Receives |
|---|---|---|
| Study group - Intensive ankle/hand robot rehab | Experimental | Device: Motor relearning training with wearable ankle robot, Device: Passive stretching with wearable ankle robot, Device: Gamed-based active movement training with wearable ankle robotAnkle/Hand robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance |
| Control group - Mild ankle/hand robot rehab | Active comparator | Device: Passive movement with limited wearable ankle robot, Device: Active movement training with limited wearable ankle robot, Device: Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robotThe 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 |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor relearning training with wearable ankle robotAnkle motor control relearning training under real-time feedback | Device | Study group - Intensive ankle/hand robot rehab |
| Passive stretching with wearable ankle robotPassive stretching under intelligent robotic control | Device | Study group - Intensive ankle/hand robot rehab |
| Gamed-based active movement training with wearable ankle robotActive movement training through movement games with robotic assistance | Device | Study group - Intensive ankle/hand robot rehab |
| Passive movement with limited wearable ankle robotPassive movement in the joint middle range of motion | Device | Control group - Mild ankle/hand robot rehab |
| Active movement training with limited wearable ankle robotActive movement training without robotic assistance | Device | Control group - Mild ankle/hand robot rehab |
| Ankle/Wrist torque and motion measurement with limited wearable ankle/wrist robotAnkle/Wrist torque and motion measurement with no real-time feedback | Device | Control group - Mild ankle/hand robot rehab |
Primary outcome
Fugl-Meyer Lower Extremity (FMLE)
Time frame: At the beginning and end of 3-week training, and 1 month after the treatment ends]
The Fugl-Meyer Lower Extremity (FMLE) assessment is a measure of lower extremity (LE) motor and sensory impairments. The FMLE scale ranges from 0 to 34, with higher scores indicating better motor function.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Background: PubMed 34665733Zhang 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.
- Background: PubMed 22466792Krakauer 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.
- Background: PubMed 21571152Langhorne P, Bernhardt J, Kwakkel G. Stroke rehabilitation. Lancet. 2011 May 14;377(9778):1693-702. doi: 10.1016/S0140-6736(11)60325-5.
- Background: PubMed 8734610Nudo 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.
- Background: PubMed 27337720Ren 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.
- Background: PubMed 12509602Sanger 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.
- Background: PubMed 16344031Selles 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.
- Background: PubMed 24792141Sukal-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.
- Background: PubMed 23648617Waldman G, Yang CY, Ren Y, Liu L, Guo X, Harvey RL, Roth EJ, Zhang LQ. Effects of robot-guided passive stretching and active movement training of ankle and mobility impairments in stroke. NeuroRehabilitation. 2013;32(3):625-34. doi: 10.3233/NRE-130885.
- Background: PubMed 21343525Wu YN, Hwang M, Ren Y, Gaebler-Spira D, Zhang LQ. Combined passive stretching and active movement rehabilitation of lower-limb impairments in children with cerebral palsy using a portable robot. Neurorehabil Neural Repair. 2011 May;25(4):378-85. doi: 10.1177/1545968310388666. Epub 2011 Feb 22.
- Background: PubMed 20132137Wu YN, Ren Y, Goldsmith A, Gaebler D, Liu SQ, Zhang LQ. Characterization of spasticity in cerebral palsy: dependence of catch angle on velocity. Dev Med Child Neurol. 2010 Jun;52(6):563-9. doi: 10.1111/j.1469-8749.2009.03602.x. Epub 2010 Jan 28.
- Background: PubMed 9535973Xerri C, Merzenich MM, Peterson BE, Jenkins W. Plasticity of primary somatosensory cortex paralleling sensorimotor skill recovery from stroke in adult monkeys. J Neurophysiol. 1998 Apr;79(4):2119-48. doi: 10.1152/jn.1998.79.4.2119.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li-Qun Zhang principal investigator
University of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor relearning training with wearable ankle robot, Passive stretching with wearable ankle robot and Gamed-based active movement training with wearable ankle robot in people with Traumatic Brain Injury, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Soh-Hyun Hur (410 706-8625, SoHur@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06465290, which also lists 28 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.