Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments
Primary Purpose
Cerebrovascular Accident, Hemiparesis, Hemiplegia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HAS Training
HAT training
Bimanual Training
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Accident focused on measuring Cerebrovascular Accident, Robotics, Virtual Reality, Rehabilitation, Neuroplasticity
Eligibility Criteria
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
Sites / Locations
- New Jersey Institute of Technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Train Paretic Hand and Arm Separate
Train Paretic Hand and Arm Together
Train Both Hands Together in VE
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Jebsen Test of Hand Function
Secondary Outcome Measures
Change in Wolf Motor Function Test
Change in 9 Hole Peg Test
Change in Box and Blocks Test
Change in Robotically Collected Kinematics
Change in Reach to Grasp Test
Full Information
NCT ID
NCT01072461
First Posted
February 16, 2010
Last Updated
October 6, 2015
Sponsor
New Jersey Institute of Technology
Collaborators
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01072461
Brief Title
Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments
Official Title
Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New Jersey Institute of Technology
Collaborators
Rutgers, The State University of New Jersey
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Accident, Hemiparesis, Hemiplegia
Keywords
Cerebrovascular Accident, Robotics, Virtual Reality, Rehabilitation, Neuroplasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Train Paretic Hand and Arm Separate
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Train Paretic Hand and Arm Together
Arm Type
Experimental
Arm Title
Train Both Hands Together in VE
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
HAS Training
Other Intervention Name(s)
Isolated UE training
Intervention Description
Robotically measured and facilitated training of the hemiparetic hand and arm in isolation, in a three dimensional haptically rendered virtual environment.
Intervention Type
Behavioral
Intervention Name(s)
HAT training
Other Intervention Name(s)
Integrated UE training
Intervention Description
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
Intervention Name(s)
Bimanual Training
Other Intervention Name(s)
Bilateral UE training
Intervention Description
Robotically measured and facilitated training of the hemiparetic hand and non-hemiparetic hand together, in a three dimensional haptically rendered virtual environment
Primary Outcome Measure Information:
Title
Change in Jebsen Test of Hand Function
Time Frame
Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training
Secondary Outcome Measure Information:
Title
Change in Wolf Motor Function Test
Time Frame
Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training
Title
Change in 9 Hole Peg Test
Time Frame
Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training
Title
Change in Box and Blocks Test
Time Frame
Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training
Title
Change in Robotically Collected Kinematics
Time Frame
1 day before training and 1 day after training
Title
Change in Reach to Grasp Test
Time Frame
1 day before training and 1 day after training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergei V. Adamovich, PhD
Organizational Affiliation
New Jersey Institute of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Jersey Institute of Technology
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19713617
Citation
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.
Results Reference
background
PubMed Identifier
19965144
Citation
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.
Results Reference
background
PubMed Identifier
22592063
Citation
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.
Results Reference
background
PubMed Identifier
23314780
Citation
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.
Results Reference
background
PubMed Identifier
23197454
Citation
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.
Results Reference
background
PubMed Identifier
22672345
Citation
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.
Results Reference
background
PubMed Identifier
23366942
Citation
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.
Results Reference
background
PubMed Identifier
24370569
Citation
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.
Results Reference
background
PubMed Identifier
25571311
Citation
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.
Results Reference
background
PubMed Identifier
25653367
Citation
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.
Results Reference
background
PubMed Identifier
19965145
Citation
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.
Results Reference
result
PubMed Identifier
19666345
Citation
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.
Results Reference
result
PubMed Identifier
19615045
Citation
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.
Results Reference
result
PubMed Identifier
21575185
Citation
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.
Results Reference
result
PubMed Identifier
25148846
Citation
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.
Results Reference
result
PubMed Identifier
26084322
Citation
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.
Results Reference
result
PubMed Identifier
23366943
Citation
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.
Results Reference
result
PubMed Identifier
22254998
Citation
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.
Results Reference
result
PubMed Identifier
22275632
Citation
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.
Results Reference
result
PubMed Identifier
23366834
Citation
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.
Results Reference
result
PubMed Identifier
25570772
Citation
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.
Results Reference
result
Learn more about this trial
Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments
We'll reach out to this number within 24 hrs