Evaluation of Robot Assisted Neuro-Rehabilitation

NCT01253018 | Completed Phase 1 Results DMC

• 1 other identifier: B6935-R
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Keywords

stroke; robotics; upper extremity rehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Motor Upper Extremity Assessment

  This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.

  Baseline, 12 week, and 24 week retention

Secondary Outcomes (3)

• Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)

  week 12

• Wolf Motor Function Test (WMFT)

  Baseline, 12 week, and 24 week retention

• Stroke Impact Scale: Hand Subscale

  Baseline, 12 week and 24 week retention

Study Arms (2)

Robot Therapy

EXPERIMENTAL

12 weeks of robotic therapy

Behavioral: Robot Therapy

Transition to Task Training

ACTIVE COMPARATOR

12 weeks of task specific practice combined with robotic therapy

Behavioral: Transition to Task Training

Interventions

Robot Therapy BEHAVIORAL

Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.

Also known as: Upper extremity (UE) robot-assisted exercise

Robot Therapy

Transition to Task Training BEHAVIORAL

Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.

Transition to Task Training

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Massachusetts Institute of Technology: collaborator
• University of Maryland, College Park: collaborator

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

• Conroy SS, Wittenberg GF, Krebs HI, Zhan M, Bever CT, Whitall J. Robot-Assisted Arm Training in Chronic Stroke: Addition of Transition-to-Task Practice. Neurorehabil Neural Repair. 2019 Sep;33(9):751-761. doi: 10.1177/1545968319862558. Epub 2019 Jul 22.

  PMID: 31328671 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The amount of change on our primary outcome measure (FM) for this population of stroke survivors with moderated to severe upper extremity motor impairment was less than predicted (4 points vs. 8) resulting in the study groups being underpowered.

Results Point of Contact

• Title: Dr. Christopher T. Bever, Jr. MD, MBA
• Organization: VA Maryland Health Care System

christopher.bever@va.gov

(410) 605-7000

Study Officials

• Christopher T. Bever, MD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2010
• First Posted: December 3, 2010
• Study Start: April 27, 2011
• Primary Completion: January 16, 2015
• Study Completion: January 30, 2015
• Last Updated: October 30, 2019
• Results First Posted: January 7, 2016

Record last verified: 2019-10

Locations

US (1)