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FINGER Robot Therapy Study

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ClinicalTrials.gov Identifier: NCT02048826
Recruitment Status : Unknown
Verified November 2013 by David Reinkensmeyer, University of California, Irvine.
Recruitment status was:  Recruiting
First Posted : January 29, 2014
Last Update Posted : January 29, 2014
Sponsor:
Information provided by (Responsible Party):
David Reinkensmeyer, University of California, Irvine

Brief Summary:
The purpose of this study is to determine the effectiveness of training hand movement using FINGER robot after stroke. FINGER is a robot that measures finger movements and allows users to play computer games using those movements.

Condition or disease Intervention/treatment Phase
Cerebrovascular Accident Device: FINGER I Device: FINGER II Device: FINGER III Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Influence of Timing on Motor Learning
Study Start Date : November 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: FINGER I
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with first setting at a minimum of 3 days per week, 1 hour per day with the exercise program
Device: FINGER I
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I

Device: FINGER II
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II

Device: FINGER III
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III

Experimental: FINGER II
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with a second setting at a minimum of 3 days per week, 1 hour per day with the exercise program
Device: FINGER I
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I

Device: FINGER II
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II

Device: FINGER III
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III

Experimental: FINGER III
Subjects participate in 3 weeks of exercising with the experimental device: FINGER robot with third setting at a minimum of 3 days per week, 1 hour per day with the exercise program
Device: FINGER I
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I

Device: FINGER II
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II

Device: FINGER III
FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting III




Primary Outcome Measures :
  1. Motor and Strength outcome measure using Box and Block Test [ Time Frame: 11 weeks ]

Secondary Outcome Measures :
  1. Motor and Strength measure using Action Research Arm Test [ Time Frame: 11 weeks ]
  2. Motor, Strength and Sensory using Fugl-Meyer Test [ Time Frame: 11 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80 years of age
  • Have history of stroke affecting the arm, at least 6 months prior to enrollment
  • have arm and/or hand weakness as measured on a standard clinical scale
  • do not have active major psychological problems, or problems affecting the stroke-affected arm or hand besides the stroke
  • do not have active major brain disease other than the stroke
  • have absence of pain in the stroke-affected arm and hand

Exclusion Criteria:

  • severe stiffness of the arm or hand as measured on a standard clinical scale
  • severe problems speaking or understanding speech as measured on a standard clinical scale
  • severe reduced level of consciousness
  • severe loss ability to sense movement of your limbs as measured on a standard clinical scale
  • currently pregnant
  • difficulty in understanding or complying with the instructions given by the researcher
  • inability to perform the experimental task that will be studied
  • increased pain with movement of the stroke-affected arm or hand

Exclusion criteria that will prevent subjects from participating in the MRI:

  • Subjects having any implanted metal such as metallic splinters, metallic surgical clips, prosthetic heart valves, pacemakers, neuro-stimulation devices, orthodontic work that contains ferromagnetic materials,
  • Subjects whose occupation or activities may cause accidental lodging of ferromagnetic materials, or that may have imbedded metal fragments from military activities, unless cleared by a screening head CT scan
  • Subjects with tattoo(s) presenting metallic or ferromagnetic color ingredients or with facial make-up
  • Subjects who have claustrophobia
  • Subjects who are currently pregnant or breastfeeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048826


Contacts
Contact: Vicky Chan, MSPT (949) 824-8423 vchan2@uci.edu
Contact: Renee Augsburger (949) 824-8423 raugsbur@uci.edu

Locations
United States, California
University of California, Irvine Recruiting
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: David Reinkensmeyer, PhD University of California, Irvine

Responsible Party: David Reinkensmeyer, Professor of Anatomy and Neurobiology, University of California, Irvine
ClinicalTrials.gov Identifier: NCT02048826     History of Changes
Other Study ID Numbers: HS#2008-6432
First Posted: January 29, 2014    Key Record Dates
Last Update Posted: January 29, 2014
Last Verified: November 2013

Keywords provided by David Reinkensmeyer, University of California, Irvine:
stroke

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases