Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by New Jersey Institute of Technology.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
New Jersey Institute of Technology
ClinicalTrials.gov Identifier:
NCT01072461
First received: February 16, 2010
Last updated: July 27, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Cerebrovascular Accident
Hemiparesis
Hemiplegia
Behavioral: HAS Training
Behavioral: HAT training
Behavioral: Bimanual Training
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Hand Rehabilitation Post-Stroke Using Interactive Virtual Environments

Resource links provided by NLM:


Further study details as provided by New Jersey Institute of Technology:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Wolf Motor Function Test [ Time Frame: Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training ] [ Designated as safety issue: No ]
  • Change in 9 Hole Peg Test [ Time Frame: Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training ] [ Designated as safety issue: No ]
  • Change in Box and Blocks Test [ Time Frame: Two Weeks Prior to Training, Immediately Prior to Training, Immediately After Training, 3 Months After Training ] [ Designated as safety issue: No ]
  • Change in Robotically Collected Kinematics [ Time Frame: 1 day before training and 1 day after training ] [ Designated as safety issue: No ]
  • Change in Reach to Grasp Test [ Time Frame: 1 day before training and 1 day after training ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: March 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: HAS Training
Robotically measured and facilitated training of the hemiparetic hand and arm in isolation, in a three dimensional haptically rendered virtual environment.
Other Name: Isolated UE training
Experimental: Train Paretic Hand and Arm Together 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
Other Name: Integrated UE training
Experimental: Train Both Hands Together in VE 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
Other Name: Bilateral UE training

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01072461

Contacts
Contact: Gerard G Fluet, DPT (732) 986-8621 fluetge@umdnj.edu

Locations
United States, New Jersey
New Jersey Institute of Technology Recruiting
Newark, New Jersey, United States, 07102
Principal Investigator: Sergei V. Adamovich, PhD         
Sponsors and Collaborators
New Jersey Institute of Technology
Investigators
Principal Investigator: Sergei V. Adamovich, PhD New Jersey Institute of Technology
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sergei V. Adamovich PhD, New Jersey Institute of Technology
ClinicalTrials.gov Identifier: NCT01072461     History of Changes
Other Study ID Numbers: 5 R01 HD058301-02
Study First Received: February 16, 2010
Last Updated: July 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by New Jersey Institute of Technology:
Cerebrovascular Accident
Robotics
Virtual Reality
Rehabilitation
Neuroplasticity

Additional relevant MeSH terms:
Cerebral Infarction
Hemiplegia
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014