Study Results
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Basic Information
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RECRUITING
NA
72 participants
INTERVENTIONAL
2018-10-14
2026-12-31
Brief Summary
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Detailed Description
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Aim 1. To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation.
Hypothesis 1: Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone.
Aim 2. To examine the efficacy of combining passive stretching with active (assistive or resistive) training for the shoulder, elbow, wrist, and hand.
Hypothesis 2: Multi-joint intelligent stretching followed by active (assistive or resistive) movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone.
Subjects will be assigned randomly with equal chance to one of four groups. Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention (arm or hand). Half of all the subjects will be assigned to the stretching groups and the other half to the passive movement groups. Half of the subjects will be assigned to the arm-training and the remaining half to hand-training groups. Arm-training groups will use the IntelliArm, hand-training groups will use the hand robot. For those assigned to the stretching groups, subjects will complete up to 30 minutes of passive stretching with the IntelliArm or the hand robot. For those assigned to the passive movement condition, subjects will do the robot according to their group assignment and wear it for up to 30 minutes with little to no stretching preceding the active therapy session. For each group, the initial about 30 minutes of stretching or relaxing will be followed by 45-60 minutes of active therapy with the IntelliArm or hand robot (depending on group assignment), for a total session time of 75-90 minutes.
The 4 groups of subjects will be compared against each other.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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IntelliArm with passive stretching
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.
Passive stretching
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
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
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.
Passive movement
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
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.
The hand robot with passive stretching
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.
Passive stretching
Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.
Hand robot
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
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.
Passive movement
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.
Hand robot
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.
Interventions
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Passive stretching
Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.
Passive movement
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
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.
Hand robot
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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National Institute on Disability, Independent Living, and Rehabilitation Research
FED
North Carolina State University
OTHER
University of Maryland, Baltimore
OTHER
Responsible Party
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Li-Qun Zhang
Professor
Principal Investigators
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Li-Qun Zhang, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Maryland, Baltimore
Locations
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University of Maryland, Baltimore
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
Mayer NH, Esquenazi A, Childers MK. Common patterns of clinical motor dysfunction. Muscle Nerve Suppl. 1997;6:S21-35.
Shumway-Cook A, Woollacott MH (2001) Motor Control: Theory and Practical Applications, 2nd ed. vol. Chapter 6. Philadelphia: Lippincott Williams & Wilkins.
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.
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.
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.
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.
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.
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.
Zhang LQ, Xu D, Kang SH, Roth EJ, Ren Y. Multi-Joint Somatosensory Assessment in Patients Post Stroke. BMES Ann Meeting, Phoenix. 2017.
Other Identifiers
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HP-00076764
Identifier Type: -
Identifier Source: org_study_id
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