Facilitating Neuroplastic Changes of Acute Stroke Survivors

NCT06404268 | Recruiting Phase 1 DMC

• 1 other identifier: HP-00110205
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 2

Brief 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. The early acute stroke rehabilitation device will be evaluated in this clinical trial.

Conditions

Stroke

Keywords

Stroke; Paraplegia; Acute

Outcome Measures

Primary Outcomes (1)

• 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.

  At the beginning and end of 3-week training, and 1 month after the treatment ends]

Secondary Outcomes (6)

• Active range of motion (AROM)

  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.

  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

  At the beginning and end of 3-week training, and 1 month after the treatment ends

• Modified Ashworth Scale (MAS)

  At the beginning and end of 3-week training, and 1 month after the treatment ends

• Berg Balance Scale

  At the beginning and end of 3-week training, and 1 month after the treatment ends

Study Arms (2)

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

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

Device: Passive movement; Device: Active movement training; Device: Ankle torque and motion measurement

Interventions

Motor relearning training DEVICE

Ankle motor control relearning training under real-time feedback

Study group - Wearable ankle robot rehab

Passive stretching DEVICE

Passive stretching under intelligent robotic control

Study group - Wearable ankle robot rehab

Gamed-based active movement training DEVICE

Active movement training through movement games with robotic assistance

Study group - Wearable ankle robot rehab

Passive movement DEVICE

Passive movement in the joint middle range of motion

Control group - Limited wearable ankle robot rehab

Active movement training DEVICE

Active movement training without robotic assistance

Control group - Limited wearable ankle robot rehab

Ankle torque and motion measurement DEVICE

Ankle torque and motion measurement with no real-time feedback

Control group - Limited wearable ankle robot rehab

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• ≤Manual Muscle Testing (MMT)\<=2
• Age 30-85
• Ankle impairments including stiff calf muscles and/or inadequate dorsiflexion

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (2)

University of Maryland Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

UMROI

Baltimore, Maryland, 21207, United States

RECRUITING

Related Publications (28)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Waldman 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.

  PMID: 23648617 BACKGROUND

• Wu 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.

  PMID: 21343525 BACKGROUND

• Wu 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.

  PMID: 20132137 BACKGROUND

• Xerri 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.

  PMID: 9535973 BACKGROUND

• Yang 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.

  PMID: 23063880 BACKGROUND

• Zhang 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.

  PMID: 23636726 BACKGROUND

• Zhang 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.

  PMID: 11535659 BACKGROUND

• Zhang LQ, Wang G, Nishida T, Xu D, Sliwa JA, Rymer WZ. Hyperactive tendon reflexes in spastic multiple sclerosis: measures and mechanisms of action. Arch Phys Med Rehabil. 2000 Jul;81(7):901-9. doi: 10.1053/apmr.2000.5582.

  PMID: 10896002 BACKGROUND

• Zhao H, Wu YN, Hwang M, Ren Y, Gao F, Gaebler-Spira D, Zhang LQ. Changes of calf muscle-tendon biomechanical properties induced by passive-stretching and active-movement training in children with cerebral palsy. J Appl Physiol (1985). 2011 Aug;111(2):435-42. doi: 10.1152/japplphysiol.01361.2010. Epub 2011 May 19.

  PMID: 21596920 BACKGROUND

• Albert SJ, Kesselring J. Neurorehabilitation of stroke. J Neurol. 2012 May;259(5):817-32. doi: 10.1007/s00415-011-6247-y. Epub 2011 Oct 1.

  PMID: 21964750 BACKGROUND

• Bernhardt J, Chan J, Nicola I, Collier JM. Little therapy, little physical activity: rehabilitation within the first 14 days of organized stroke unit care. J Rehabil Med. 2007 Jan;39(1):43-8. doi: 10.2340/16501977-0013.

  PMID: 17225037 BACKGROUND

• Bernhardt J, Dewey H, Thrift A, Donnan G. Inactive and alone: physical activity within the first 14 days of acute stroke unit care. Stroke. 2004 Apr;35(4):1005-9. doi: 10.1161/01.STR.0000120727.40792.40. Epub 2004 Feb 26.

  PMID: 14988574 BACKGROUND

• Chung SG, van Rey E, Bai Z, Rymer WZ, Roth EJ, Zhang LQ. Separate quantification of reflex and nonreflex components of spastic hypertonia in chronic hemiparesis. Arch Phys Med Rehabil. 2008 Apr;89(4):700-10. doi: 10.1016/j.apmr.2007.09.051.

  PMID: 18374001 BACKGROUND

• Chung SG, Van Rey E, Bai Z, Roth EJ, Zhang LQ. Biomechanic changes in passive properties of hemiplegic ankles with spastic hypertonia. Arch Phys Med Rehabil. 2004 Oct;85(10):1638-46. doi: 10.1016/j.apmr.2003.11.041.

  PMID: 15468024 BACKGROUND

• Chen K, Wu YN, Ren Y, Liu L, Gaebler-Spira D, Tankard K, Lee J, Song W, Wang M, Zhang LQ. Home-Based Versus Laboratory-Based Robotic Ankle Training for Children With Cerebral Palsy: A Pilot Randomized Comparative Trial. Arch Phys Med Rehabil. 2016 Aug;97(8):1237-43. doi: 10.1016/j.apmr.2016.01.029. Epub 2016 Feb 20.

  PMID: 26903143 BACKGROUND

• Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society; Delgado MR, Hirtz D, Aisen M, Ashwal S, Fehlings DL, McLaughlin J, Morrison LA, Shrader MW, Tilton A, Vargus-Adams J. Practice parameter: pharmacologic treatment of spasticity in children and adolescents with cerebral palsy (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2010 Jan 26;74(4):336-43. doi: 10.1212/WNL.0b013e3181cbcd2f.

  PMID: 20101040 BACKGROUND

• Gao F, Grant TH, Roth EJ, Zhang LQ. Changes in passive mechanical properties of the gastrocnemius muscle at the muscle fascicle and joint levels in stroke survivors. Arch Phys Med Rehabil. 2009 May;90(5):819-26. doi: 10.1016/j.apmr.2008.11.004.

  PMID: 19406302 BACKGROUND

• Gao F, Ren Y, Roth EJ, Harvey R, Zhang LQ. Effects of repeated ankle stretching on calf muscle-tendon and ankle biomechanical properties in stroke survivors. Clin Biomech (Bristol). 2011 Jun;26(5):516-22. doi: 10.1016/j.clinbiomech.2010.12.003. Epub 2011 Jan 6.

  PMID: 21211873 BACKGROUND

• Gao F, Zhang LQ. Altered contractile properties of the gastrocnemius muscle poststroke. J Appl Physiol (1985). 2008 Dec;105(6):1802-8. doi: 10.1152/japplphysiol.90930.2008. Epub 2008 Oct 23.

  PMID: 18948443 BACKGROUND

• Jenkins WM, Merzenich MM. Reorganization of neocortical representations after brain injury: a neurophysiological model of the bases of recovery from stroke. Prog Brain Res. 1987;71:249-66. doi: 10.1016/s0079-6123(08)61829-4. No abstract available.

  PMID: 3588947 BACKGROUND

MeSH Terms

Conditions

Stroke; Paraplegia

Interventions

Muscle Stretching Exercises; Range of Motion, Articular

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Li-Qun Zhang

  University of Maryland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soh-Hyun Hur

CONTACT

410 706-8625; SoHur@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized clinical trial with the study group and control group

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 8, 2024
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

US (2)