StrokePhase 1/2NCT06404268
Facilitating Neuroplastic Changes of Acute Stroke Survivors
A Phase 1/2 study testing Motor relearning training, Passive stretching and Gamed-based active movement training in people with Stroke, run by University of Maryland, Baltimore at 3 sites 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-stroke 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
- Stroke
- What is being tested?
- Motor relearning training, Passive stretching and Gamed-based active movement training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jun 2025to 31 Aug 2028
- Phase
- Phase 1/2
- 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
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of Maryland Baltimore
Baltimore, Maryland, 21201
Dali Xu, PhD
Peiwen Fu, BS
- Recruiting
UMROI
Baltimore, Maryland, 21207
Dali Xu
Peiwen Fu
- Recruiting
TIRR Memorial Hermann
Houston, Texas, 77030
Manuel Portilla-Jimenez, PhD, 346-719-4921, manuel.a.portillajimenez@uth.tmc.edu
Sheng Li, MD-PhD
About this study
Official title: Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia
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.
Read the detailed description
Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with 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.
- Conditions
- Stroke
- Being tested
- Motor relearning training, Passive stretching, Gamed-based active movement training, Passive movement, Active movement training
- Keywords
- Stroke, Paraplegia, Acute
- Medical subject headings
- Stroke, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor relearning trainingDevice
Ankle motor control relearning training under real-time feedback
Passive stretchingDevice
Passive stretching under intelligent robotic control
Gamed-based active movement trainingDevice
Active movement training through movement games with robotic assistance
Passive movementDevice
Passive movement in the joint middle range of motion
Active movement trainingDevice
Active movement training without robotic assistance
Ankle torque and motion measurementDevice
Ankle torque and motion measurement with no real-time feedback
| Study group | Role | What they receive |
|---|---|---|
| Study group - Wearable ankle robot rehab | Experimental | Wearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance Receives: Device: Motor relearning training; Device: Passive stretching; Device: Gamed-based active movement training |
| Control group - Limited wearable ankle 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; Device: Active movement training; Device: Ankle torque and motion measurement |
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) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.
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 will be measured in Newtons
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 posted8 May 2024
- Study start1 Jun 2025
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (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 StrokeStudies 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 1/2
- 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
- 68 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
- NCT06404268
- Sponsor's protocol ID
- HP-00110205
- Status last verified
- Jul 2026
- First submitted
- 1 May 2024
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: plan to share later
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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Neuroplastic Changes of Acute Stroke Survivors With Severe Hemiplegia
- ClinicalTrials.gov ID
- NCT06404268
- Acronym / sponsor ID
- HP-00110205
- Conditions
- Stroke
- Keywords
- Stroke, Paraplegia, Acute
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 May 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-stroke including patients who are paralyzed with no motor output. The early acute stroke rehabilitation device will be evaluated in this clinical trial.
Detailed description
Stroke survivors often experience loss of motor control and impaired function. Immediately after stroke, there is a time-limited window of heightened plasticity during which the greatest gains in recovery occur. Therefore, early intensive sensorimotor rehabilitation post-stroke is critical in improving functional outcomes and minimizing disability. However, acute stroke survivors often receive little active training to improve mobility during their hospital stay and they are left alone during most of the day. Especially for those acute patients with no voluntary motor output, active motor training might be even less, partly due to a lack of rehabilitation protocols to detect potential motor recovering signals sensitively and facilitate neuroplastic changes. To address this unmet clinical need, this project will develop a novel wearable rehabilitation robot suitable for in-bed acute stage rehabilitation with 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.
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 - Wearable ankle robot rehab | Experimental | Device: Motor relearning training, Device: Passive stretching, Device: Gamed-based active movement trainingWearable rehab robot with motor relearning with real-time feedback, passive stretching under intelligent control; Active movement training with robotic assistance |
| Control group - Limited wearable ankle robot rehab | Active comparator | Device: Passive movement, Device: Active movement training, Device: Ankle torque and motion measurementThe 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 trainingAnkle motor control relearning training under real-time feedback | Device | Study group - Wearable ankle robot rehab |
| Passive stretchingPassive stretching under intelligent robotic control | Device | Study group - Wearable ankle robot rehab |
| Gamed-based active movement trainingActive movement training through movement games with robotic assistance | Device | Study group - Wearable ankle robot rehab |
| Passive movementPassive movement in the joint middle range of motion | Device | Control group - Limited wearable ankle robot rehab |
| Active movement trainingActive movement training without robotic assistance | Device | Control group - Limited wearable ankle robot rehab |
| Ankle torque and motion measurementAnkle torque and motion measurement with no real-time feedback | Device | Control group - Limited wearable ankle 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) will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly.
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 will be measured in Newtons
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 23 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.
- Individual participant dataSharing planned: Undecided. plan to share later
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Motor relearning training, Passive stretching and Gamed-based active movement training in people with Stroke, run by University of Maryland, Baltimore at 3 sites 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 23 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 3 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Peiwen Fu, BS (410 706-8625, Peiwen.Fu@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 NCT06404268, 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 23 Jul 2026.