Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01322997
First received: March 16, 2011
Last updated: March 23, 2011
Last verified: March 2011
  Purpose

Stroke is the leading cause of disability in the United States. One of the reasons that it is so disabling is because of upper extremity hemiparesis (weakness in one arm), which is commonly seen after stroke.

The objective of this research is to see if a robotic system worn on the weakened arm like a brace is more useful in improving the strength and coordination of the affected arm, and those of other stroke survivors, than therapy only. Muscle weakness and lack of coordination after a stroke have great effects on how severely disabled the arm is and on quality of life after a stroke.

In this study, patients may be administered a new robotic brace as part of treatment for their affected arms. If they use this brace, your electromyography (EMG) signals will be used to control the powered arm brace. EMG signals are the small electrical signals that result from the actions of the muscles. The system will "listen" to patients' muscles, using small sensors that sit on top of the skin. The device will give the arm a "power-assist" when patients bend or straighten their elbows. The investigators want to test how easy and effective this system is to use. The investigators hypothesize that people using the robot will be more successful in their rehabilitative efforts - and that their movement will improve more - than people receiving traditional therapy.


Condition Intervention Phase
Stroke
Device: Myomo e100 Robot and repetitive task specific training
Behavioral: Repetitive task specific training (RTP) targeting the affected arm
Device: Myomo e100 neurorobotic brace
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Change from baseline to after intervention and 3 months after intervention in the amount of active movement at each joint of the affected arm. This will be measured using the upper extremity section of the Fugl-Meyer Assessment. [ Time Frame: Twice before intervention; once after intervention; 2 months after intervention. ] [ Designated as safety issue: No ]
    The primary outcome in this study is arm impairment. We will measure this using the Fugl-Meyer; a stroke-specific measure that determines how much active movement patients exhibit at each joint of the affected upper extremity.


Estimated Enrollment: 30
Study Start Date: September 2010
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Myomo + RTP
This group will be administered a regimen comprised of repetitive task specific practice (RTP) in conjunction with use of the robotic brace described elsewhere in this record.
Device: Myomo e100 Robot and repetitive task specific training
Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include about 1/2 an hour of use of a robot that targets arm function and assists with the movement of the affected arm, and about 1/2 an hour of repetitive task specific training (TRP) using the affected arm.
Active Comparator: Myomo
Patients in this group will only be administered the robotic brace described elsewhere in this record.
Device: Myomo e100 neurorobotic brace
Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. Subjects will use a robot that targets arm function and assists with the movement of the affected arm.
Active Comparator: RTP only
Patients in this group will be administered repetitive task specific practice (RTP), emphasizing use of their affected arms during performance of valued, functional tasks.
Behavioral: Repetitive task specific training (RTP) targeting the affected arm
Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include consist of repetitive task specific training (RTP) using the affected arm, in which patients use the arm to relearn valued movements using their arms.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Upper extremity Fugl Meyer score >10-< 25
  • presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
  • stroke experienced > 1 month prior to study enrollment;
  • a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
  • age > 35 < 85
  • have experienced one stroke
  • discharged from all forms of physical rehabilitation
  • Myomo brace fits on affected arm properly and without discomfort (i.e., no red marks or discomfort observed in 10 minutes of use during fitting).

Exclusion Criteria:

  • < 35 years old
  • excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale
  • excessive spasticity at the affected elbow, as defined as a score of > 4 on the Modified Ashworth Spasticity Scale
  • currently participating in any experimental rehabilitation or drug studies
  • apraxia (< 2.5 on the Alexander scale)
  • severe sensory loss in affected hand (Nottingham sensory scale at least 75% of normal)
  • severe language deficits (score < 2 on NIH Stroke Scale question 9)
  • Stroke that occurred in the brainstem
  • A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment
  • History of neurological disorder other than stroke (other neurological disorders may affect the upper extremity motor performance of subjects.)
  • Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace
  • Substantial contracture of elbow, defined as > 20 degrees of elbow flexion, as measured at the baseline evaluation.
  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: NCT01322997

Contacts
Contact: Stephen Page, PhD 513-558-2754 stephen.page@uc.edu

Locations
United States, Ohio
Univcersity of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Stephen Page, PhD    513-558-2754    stephen.page@uc.edu   
Principal Investigator: Stephen Page, PhD         
Sponsors and Collaborators
University of Cincinnati
  More Information

No publications provided

Responsible Party: Stephen J. Page, PhD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01322997     History of Changes
Other Study ID Numbers: 1R03HD062545-01
Study First Received: March 16, 2011
Last Updated: March 23, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 08, 2014