Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments

NCT ID: NCT01072461

Last Updated: 2015-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-03-31

Brief Summary

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The complexity of sensorimotor control required for hand function as well as the wide range of recovery of manipulative abilities makes rehabilitation of the hand most challenging. The investigators past work has shown that training in a virtual environment (VE) using repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to facilitate motor recovery of hand function. These findings are in accordance with current neuroscience literature in animals and motor control literature in humans. The investigators are now in a position to refine and optimize elements of the training paradigms to enhance neuroplasticity. The investigators first aim tests if and how competition among body parts for neural representations stifles functional gains from different types of training regimens. The second aim tests the functional benefits of unilateral versus bilateral training regimens.The third aim tests whether functional improvements gained from training in a virtual environment transfer to other (untrained) skills in the real world.

Detailed Description

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The complexity of sensorimotor control required for hand function as well as the wide range of recovery of manipulative abilities makes rehabilitation of the hand most challenging. The investigators past work has shown that training in a virtual environment (VE) using repetitive, adaptive algorithms has the potential to be an effective rehabilitation medium to facilitate motor recovery of hand function. These findings are in accordance with current neuroscience literature in animals and motor control literature in humans. The investigators are now in a position to refine and optimize elements of the training paradigms to enhance neuroplasticity. The investigators first aim tests if and how competition among body parts for neural representations stifles functional gains from different types of training regimens. The second aim tests the functional benefits of unilateral versus bilateral training regimens.The third aim tests whether functional improvements gained from training in a virtual environment transfer to other (untrained) skills in the real world.

Conditions

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Cerebrovascular Accident Hemiparesis Hemiplegia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Train Paretic Hand and Arm Separate

Eight three hour training sessions of robotically facilitated hand and arm training in complex virtual environments, using activities that train the fingers in isolation and other activities that train the arm in isolation.

Group Type ACTIVE_COMPARATOR

HAS Training

Intervention Type BEHAVIORAL

Robotically measured and facilitated training of the hemiparetic hand and arm in isolation, in a three dimensional haptically rendered virtual environment.

Train Paretic Hand and Arm Together

Group Type EXPERIMENTAL

HAT training

Intervention Type BEHAVIORAL

Robotically measured and facilitated training of the hemiparetic hand and arm as an integrated functional unit, in a three dimensional haptically rendered virtual environment

Train Both Hands Together in VE

Group Type EXPERIMENTAL

Bimanual Training

Intervention Type BEHAVIORAL

Robotically measured and facilitated training of the hemiparetic hand and non-hemiparetic hand together, in a three dimensional haptically rendered virtual environment

Interventions

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HAS Training

Robotically measured and facilitated training of the hemiparetic hand and arm in isolation, in a three dimensional haptically rendered virtual environment.

Intervention Type BEHAVIORAL

HAT training

Robotically measured and facilitated training of the hemiparetic hand and arm as an integrated functional unit, in a three dimensional haptically rendered virtual environment

Intervention Type BEHAVIORAL

Bimanual Training

Robotically measured and facilitated training of the hemiparetic hand and non-hemiparetic hand together, in a three dimensional haptically rendered virtual environment

Intervention Type BEHAVIORAL

Other Intervention Names

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Isolated UE training Integrated UE training Bilateral UE training

Eligibility Criteria

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Inclusion Criteria

* Six months post cerebrovascular accident
* Residual upper extremity impairment that affects participation
* At least ten degrees of active finger extension
* Tolerate passive shoulder flexion to chest level

Exclusion Criteria

* Severe neglect
* Severe aphasia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role collaborator

New Jersey Institute of Technology

OTHER

Sponsor Role lead

Responsible Party

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Sergei V. Adamovich PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergei V. Adamovich, PhD

Role: PRINCIPAL_INVESTIGATOR

New Jersey Institute of Technology

Locations

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New Jersey Institute of Technology

Newark, New Jersey, United States

Site Status

Countries

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United States

References

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Adamovich SV, Fluet GG, Tunik E, Merians AS. Sensorimotor training in virtual reality: a review. NeuroRehabilitation. 2009;25(1):29-44. doi: 10.3233/NRE-2009-0497.

Reference Type BACKGROUND
PMID: 19713617 (View on PubMed)

Tunik E, Adamovich SV. Remapping in the ipsilesional motor cortex after VR-based training: a pilot fMRI study. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1139-42. doi: 10.1109/IEMBS.2009.5335392.

Reference Type BACKGROUND
PMID: 19965144 (View on PubMed)

Fluet GG, Merians AS, Qiu Q, Lafond I, Saleh S, Ruano V, Delmonico AR, Adamovich SV. Robots integrated with virtual reality simulations for customized motor training in a person with upper extremity hemiparesis: a case study. J Neurol Phys Ther. 2012 Jun;36(2):79-86. doi: 10.1097/NPT.0b013e3182566f3f.

Reference Type BACKGROUND
PMID: 22592063 (View on PubMed)

Tunik E, Saleh S, Adamovich SV. Visuomotor discordance during visually-guided hand movement in virtual reality modulates sensorimotor cortical activity in healthy and hemiparetic subjects. IEEE Trans Neural Syst Rehabil Eng. 2013 Mar;21(2):198-207. doi: 10.1109/TNSRE.2013.2238250. Epub 2013 Jan 9.

Reference Type BACKGROUND
PMID: 23314780 (View on PubMed)

Bagce HF, Saleh S, Adamovich SV, Krakauer JW, Tunik E. Corticospinal excitability is enhanced after visuomotor adaptation and depends on learning rather than performance or error. J Neurophysiol. 2013 Feb;109(4):1097-106. doi: 10.1152/jn.00304.2012. Epub 2012 Nov 28.

Reference Type BACKGROUND
PMID: 23197454 (View on PubMed)

Bagce HF, Saleh S, Adamovich SV, Tunik E. Visuomotor gain distortion alters online motor performance and enhances primary motor cortex excitability in patients with stroke. Neuromodulation. 2012 Jul;15(4):361-6. doi: 10.1111/j.1525-1403.2012.00467.x. Epub 2012 Jun 1.

Reference Type BACKGROUND
PMID: 22672345 (View on PubMed)

Saleh S, Adamovich SV, Tunik E. Resting state functional connectivity and task-related effective connectivity changes after upper extremity rehabilitation: a pilot study. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:4559-62. doi: 10.1109/EMBC.2012.6346981.

Reference Type BACKGROUND
PMID: 23366942 (View on PubMed)

Saleh S, Adamovich SV, Tunik E. Mirrored feedback in chronic stroke: recruitment and effective connectivity of ipsilesional sensorimotor networks. Neurorehabil Neural Repair. 2014 May;28(4):344-54. doi: 10.1177/1545968313513074. Epub 2013 Dec 26.

Reference Type BACKGROUND
PMID: 24370569 (View on PubMed)

Yarossi M, Adamovich S, Tunik E. Sensorimotor cortex reorganization in subacute and chronic stroke: A neuronavigated TMS study. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:5788-91. doi: 10.1109/EMBC.2014.6944943.

Reference Type BACKGROUND
PMID: 25571311 (View on PubMed)

Schettino LF, Adamovich SV, Bagce H, Yarossi M, Tunik E. Disruption of activity in the ventral premotor but not the anterior intraparietal area interferes with on-line correction to a haptic perturbation during grasping. J Neurosci. 2015 Feb 4;35(5):2112-7. doi: 10.1523/JNEUROSCI.3000-14.2015.

Reference Type BACKGROUND
PMID: 25653367 (View on PubMed)

Qiu Q, Fluet GG, Lafond I, Merians AS, Adamovich SV. Coordination changes demonstrated by subjects with hemiparesis performing hand-arm training using the NJIT-RAVR robotically assisted virtual rehabilitation system. Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1143-6. doi: 10.1109/IEMBS.2009.5335384.

Reference Type RESULT
PMID: 19965145 (View on PubMed)

Adamovich SV, Fluet GG, Merians AS, Mathai A, Qiu Q. Incorporating haptic effects into three-dimensional virtual environments to train the hemiparetic upper extremity. IEEE Trans Neural Syst Rehabil Eng. 2009 Oct;17(5):512-20. doi: 10.1109/TNSRE.2009.2028830. Epub 2009 Aug 7.

Reference Type RESULT
PMID: 19666345 (View on PubMed)

Adamovich SV, Fluet GG, Mathai A, Qiu Q, Lewis J, Merians AS. Design of a complex virtual reality simulation to train finger motion for persons with hemiparesis: a proof of concept study. J Neuroeng Rehabil. 2009 Jul 17;6:28. doi: 10.1186/1743-0003-6-28.

Reference Type RESULT
PMID: 19615045 (View on PubMed)

Merians AS, Fluet GG, Qiu Q, Saleh S, Lafond I, Davidow A, Adamovich SV. Robotically facilitated virtual rehabilitation of arm transport integrated with finger movement in persons with hemiparesis. J Neuroeng Rehabil. 2011 May 16;8:27. doi: 10.1186/1743-0003-8-27.

Reference Type RESULT
PMID: 21575185 (View on PubMed)

Fluet GG, Merians AS, Qiu Q, Davidow A, Adamovich SV. Comparing integrated training of the hand and arm with isolated training of the same effectors in persons with stroke using haptically rendered virtual environments, a randomized clinical trial. J Neuroeng Rehabil. 2014 Aug 23;11:126. doi: 10.1186/1743-0003-11-126.

Reference Type RESULT
PMID: 25148846 (View on PubMed)

Fluet GG, Merians AS, Qiu Q, Rohafaza M, VanWingerden AM, Adamovich SV. Does training with traditionally presented and virtually simulated tasks elicit differing changes in object interaction kinematics in persons with upper extremity hemiparesis? Top Stroke Rehabil. 2015 Jun;22(3):176-84. doi: 10.1179/1074935714Z.0000000008. Epub 2015 Jan 22.

Reference Type RESULT
PMID: 26084322 (View on PubMed)

Puthenveettil S, Fluet G, Qiu Q, Adamovich S. Classification of hand preshaping in persons with stroke using Linear Discriminant Analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:4563-6. doi: 10.1109/EMBC.2012.6346982.

Reference Type RESULT
PMID: 23366943 (View on PubMed)

Boos A, Qiu Q, Fluet GG, Adamovich SV. Haptically facilitated bimanual training combined with augmented visual feedback in moderate to severe hemiplegia. Annu Int Conf IEEE Eng Med Biol Soc. 2011;2011:3111-4. doi: 10.1109/IEMBS.2011.6090849.

Reference Type RESULT
PMID: 22254998 (View on PubMed)

Qiu Q, Adamovich S, Saleh S, Lafond I, Merians AS, Fluet GG. A comparison of motor adaptations to robotically facilitated upper extremity task practice demonstrated by children with cerebral palsy and adults with stroke. IEEE Int Conf Rehabil Robot. 2011;2011:5975431. doi: 10.1109/ICORR.2011.5975431.

Reference Type RESULT
PMID: 22275632 (View on PubMed)

Rohafza M, Fluet GG, Qiu Q, Adamovich S. Correlations between statistical models of robotically collected kinematics and clinical measures of upper extremity function. Annu Int Conf IEEE Eng Med Biol Soc. 2012;2012:4120-3. doi: 10.1109/EMBC.2012.6346873.

Reference Type RESULT
PMID: 23366834 (View on PubMed)

Rohafza M, Fluet GG, Qiu Q, Adamovich S. Correlation of reaching and grasping kinematics and clinical measures of upper extremity function in persons with stroke related hemiplegia. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:3610-3. doi: 10.1109/EMBC.2014.6944404.

Reference Type RESULT
PMID: 25570772 (View on PubMed)

Other Identifiers

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5R01HD058301-02

Identifier Type: NIH

Identifier Source: org_study_id

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