Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Massachusetts Institute of Technology
University of Maryland
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01253018
First received: November 24, 2010
Last updated: October 1, 2014
Last verified: September 2014

November 24, 2010
October 1, 2014
April 2011
November 2014   (final data collection date for primary outcome measure)
Upper Extremity Impairment as measured by the Fugl-Meyer Motor Assessment [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01253018 on ClinicalTrials.gov Archive Site
Motor Cortex Excitability via Transcranial Magnetic Stimulation (TMS) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Motor Cortex Excitability via Trancranial Magnetic Stimulation (TMS) [ Time Frame: week 12 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluation of Robot Assisted Neuro-Rehabilitation
Evaluation of Robot Assisted Neuro-rehabilitation

Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm for real life situations often remains limited. The goal of this study is to determine the best way to use robotic devices and functional task training to improve the use of the stroke affected arm for real life situations. A secondary goal of this study is to determine how or if specific areas of the brain are excited before and after training. The use of a safe and painless magnetic field directed at the brain called transcranial magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of brain activity during recovery.

After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices.

Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase.

TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four.

Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
  • Behavioral: Upper extremity exercise
    Task specific practice of functional activities using the hemiparetic arm
    Other Name: Transition to task therapy
  • Behavioral: Upper extremity robotic exercise
    Robot therapy consisting of a progression through three robot modules: wrist, planar, and alternating wrist and planar robot. The progression will be sequential with four weeks of training on each robotic device.
  • Experimental: Arm 1
    12 weeks of task specific practice combined with robotic therapy
    Intervention: Behavioral: Upper extremity exercise
  • Active Comparator: Arm 2
    12 weeks of robotic therapy
    Intervention: Behavioral: Upper extremity robotic exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
December 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses
  • Adequate language, and cognitive function to participate in training, testing, and informed consent process
  • The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38
  • Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke
  • Men or women over 21 years of age

Exclusion Criteria:

  • Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions
  • Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer
  • Botox injection to the study arm within 3 months of enrollment or during the study period
  • Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01253018
B6935-R
Yes
Department of Veterans Affairs
Department of Veterans Affairs
  • Massachusetts Institute of Technology
  • University of Maryland
Principal Investigator: Christopher Bever, MD VA Maryland Health Care System, Baltimore
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP