Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments

Cerebrovascular Accident Clinical Trial

Official title:

Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01072461
• Other study ID #: 5R01HD058301-02
• Status: Completed
• Phase: Phase 1
• First received: February 16, 2010
• Last updated: October 6, 2015
• Start date: March 2009
• Est. completion date: March 2015

Study information

• Verified date: October 2015
• Source: New Jersey Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: March 2015
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Hemiparesis
• Hemiplegia
• Stroke

Intervention

Behavioral:
• HAS Training
Robotically measured and facilitated training of the hemiparetic hand and arm in isolation, in a three dimensional haptically rendered virtual environment.
• 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
• Bimanual Training
Robotically measured and facilitated training of the hemiparetic hand and non-hemiparetic hand together, in a three dimensional haptically rendered virtual environment

Locations

Country	Name	City	State
United States	New Jersey Institute of Technology	Newark	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
New Jersey Institute of Technology	Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (21)

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. — View 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.2009.2028 — View 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. Review. — View 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. — View 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. — View Citation

Boos A, Qiu Q, Fluet GG, Adamovich SV. Haptically facilitated bimanual training combined with augmented visual feedback in moderate to severe hemiplegia. Conf Proc IEEE Eng Med Biol Soc. 2011;2011:3111-4. doi: 10.1109/IEMBS.2011.6090849. — View 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 Neur — View 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. — View 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 Str — View 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: 10.1186/1743-0 — View Citation

Puthenveettil S, Fluet G, Qiu Q, Adamovich S. Classification of hand preshaping in persons with stroke using Linear Discriminant Analysis. Conf Proc IEEE Eng Med Biol Soc. 2012;2012:4563-6. doi: 10.1109/EMBC.2012.6346982. — View 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; — View 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. Conf Proc IEEE Eng Med Biol Soc. 2009; — View 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. Conf Proc IEEE Eng Med Biol Soc. 2014;2014:3610-3. doi: 10.1109/EMBC.2014 — View Citation

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

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

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

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

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Jebsen Test of Hand Function		Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training	No
Secondary	Change in Wolf Motor Function Test		Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training	No
Secondary	Change in 9 Hole Peg Test		Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training	No
Secondary	Change in Box and Blocks Test		Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training	No
Secondary	Change in Robotically Collected Kinematics		1 day before training and 1 day after training	No
Secondary	Change in Reach to Grasp Test		1 day before training and 1 day after training	No