Robot Aided Rehabilitation - Intervention

NCT02359253 | Recruiting

• 1 other identifier: HP-00076764
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand, thereby rendering them difficult to diagnose and treat. The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand, then conduct impairment-specific treatment, and determine the effects of arm versus hand training and the effects of passive stretching before active movement training.

Conditions

Stroke

Keywords

Stroke; Spasticity; Arm; Hand; Robotic therapy

Outcome Measures

Primary Outcomes (1)

• Changes from baseline Graded Wolf Motor Function Test (WMFT) at two time points

  The WMFT is a quantitative measure of upper extremity motor ability through timed and functional tasks.

  Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention

Secondary Outcomes (9)

• Changes from baseline Fugl-Meyer Upper Extremity at two time points

  Within 2 week prior to intervention, 2 week following intervention, and 2 months following intervention

• Changes from baseline Chedoke McMaster Stroke Assessment: Impairment Inventory of Arm and Hand at two time points

  Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

• Changes from baseline Modified Ashworth Scale (MAS) at two time points

  Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

• Changes from baseline Action Research Arm Test (ARAT) at two time points

  Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

• Changes from baseline Grip Strength & Pinch Strength at two time points

  Within 2 weeks prior to intervention, 2 weeks following intervention, and 2 months following intervention

Study Arms (4)

IntelliArm with passive stretching

EXPERIMENTAL

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

Other: Passive stretching; Other: IntelliArm

IntelliArm with passive movement

EXPERIMENTAL

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the IntelliArm for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the IntelliArm.

Other: Passive movement; Other: IntelliArm

The hand robot with passive stretching

EXPERIMENTAL

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will complete up to 30 minutes of strong passive stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Other: Passive stretching; Other: Hand robot

The hand robot with passive movement

EXPERIMENTAL

Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Subjects will wear the hand robot for up to 30 minutes with gentle passive movement or little stretching, then followed by 45-60 minutes of active movement training with the hand robot.

Other: Passive movement; Other: Hand robot

Interventions

Passive stretching OTHER

Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.

IntelliArm with passive stretching; The hand robot with passive stretching

Passive movement OTHER

Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces.

IntelliArm with passive movement; The hand robot with passive movement

IntelliArm OTHER

During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.

IntelliArm with passive movement; IntelliArm with passive stretching

Hand robot OTHER

During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.

The hand robot with passive movement; The hand robot with passive stretching

Eligibility Criteria

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

You may qualify if:

• First focal unilateral lesion, ischemic or hemorrhagic
• Had a stroke 1-12 months prior to enrollment
• Rated between stages 2-4 on the Chedoke McMaster Stroke Assessment Impairment Inventory: Stage of Recovery of the Arm and Hand

You may not qualify if:

• Apraxia
• Score of less than 22 on the Mini Mental Status Exam
• Severe pain in the shoulder by a self-rating of 7 out of 10 or greater
• Severe contracture in the upper extremity
• Unable to sit in a chair for 3 consecutive hours
• Unrelated musculoskeletal injuries
• Poor fit into equipment used in study
• Botox injection in upper extremity within 4 months
• Concurrent participation in gait or upper extremity intervention studies

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• North Carolina State University: collaborator

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Related Publications (14)

• Go AS, Mozaffarian D, Roger VL, Benjamin EJ, Berry JD, Borden WB, Bravata DM, Dai S, Ford ES, Fox CS, Franco S, Fullerton HJ, Gillespie C, Hailpern SM, Heit JA, Howard VJ, Huffman MD, Kissela BM, Kittner SJ, Lackland DT, Lichtman JH, Lisabeth LD, Magid D, Marcus GM, Marelli A, Matchar DB, McGuire DK, Mohler ER, Moy CS, Mussolino ME, Nichol G, Paynter NP, Schreiner PJ, Sorlie PD, Stein J, Turan TN, Virani SS, Wong ND, Woo D, Turner MB; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics--2013 update: a report from the American Heart Association. Circulation. 2013 Jan 1;127(1):e6-e245. doi: 10.1161/CIR.0b013e31828124ad. Epub 2012 Dec 12. No abstract available.

  PMID: 23239837 BACKGROUND

• Haggard P, Wing A. Coordinated responses following mechanical perturbation of the arm during prehension. Exp Brain Res. 1995;102(3):483-94. doi: 10.1007/BF00230652.

  PMID: 7737394 BACKGROUND

• Hoffmann G, Schmit BD, Kahn JH, Kamper DG. Effect of sensory feedback from the proximal upper limb on voluntary isometric finger flexion and extension in hemiparetic stroke subjects. J Neurophysiol. 2011 Nov;106(5):2546-56. doi: 10.1152/jn.00522.2010. Epub 2011 Aug 10.

  PMID: 21832028 BACKGROUND

• Kamper DG, Harvey RL, Suresh S, Rymer WZ. Relative contributions of neural mechanisms versus muscle mechanics in promoting finger extension deficits following stroke. Muscle Nerve. 2003 Sep;28(3):309-18. doi: 10.1002/mus.10443.

  PMID: 12929190 BACKGROUND

• Kamper DG, Rymer WZ. Quantitative features of the stretch response of extrinsic finger muscles in hemiparetic stroke. Muscle Nerve. 2000 Jun;23(6):954-61. doi: 10.1002/(sici)1097-4598(200006)23:63.0.co;2-0.

  PMID: 10842274 BACKGROUND

• Mayer NH, Esquenazi A, Childers MK. Common patterns of clinical motor dysfunction. Muscle Nerve Suppl. 1997;6:S21-35.

  PMID: 9826981 BACKGROUND

• Shumway-Cook A, Woollacott MH (2001) Motor Control: Theory and Practical Applications, 2nd ed. vol. Chapter 6. Philadelphia: Lippincott Williams & Wilkins.

  BACKGROUND

• Ren Y, Kang SH, Park HS, Wu YN, Zhang LQ. Developing a multi-joint upper limb exoskeleton robot for diagnosis, therapy, and outcome evaluation in neurorehabilitation. IEEE Trans Neural Syst Rehabil Eng. 2013 May;21(3):490-9. doi: 10.1109/TNSRE.2012.2225073. Epub 2012 Oct 19.

  PMID: 23096119 BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 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

• 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

• 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

• Zhang LQ, Son J, Park HS, Kang SH, Lee Y, Ren Y. Changes of Shoulder, Elbow, and Wrist Stiffness Matrix Post Stroke. IEEE Trans Neural Syst Rehabil Eng. 2017 Jul;25(7):844-851. doi: 10.1109/TNSRE.2017.2707238. Epub 2017 May 23.

  PMID: 28541901 BACKGROUND

• Zhang LQ, Xu D, Kang SH, Roth EJ, Ren Y. Multi-Joint Somatosensory Assessment in Patients Post Stroke. BMES Ann Meeting, Phoenix. 2017.

  BACKGROUND

MeSH Terms

Conditions

Stroke; Muscle Spasticity

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; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; 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, Ph.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soh-Hyun Hur

CONTACT

(410) 706-1625; sohur@som.umaryland.edu

Kyung Koh, Ph.D.

CONTACT

(410) 706-8625; KKoh@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: February 9, 2015
• Study Start: October 14, 2018
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)