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

Stroke Clinical Trial

Official title:

Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01322997
• Other study ID #: 1R03HD062545-01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: March 16, 2011
• Last updated: March 23, 2011
• Start date: September 2010
• Est. completion date: May 2012

Study information

• Verified date: March 2011
• Source: University of Cincinnati
• Contact: Stephen Page, PhD
• Phone: 513-558-2754
• Email: stephen.page[@]uc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Upper extremity Fugl Meyer score >10-< 25

• presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 uV 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

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.

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.

Locations

Country	Name	City	State
United States	Univcersity of Cincinnati	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Twice before intervention; once after intervention; 2 months after intervention.	No