Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke
| Status: | Completed |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 35 - 85 |
| Updated: | 4/2/2016 |
| Start Date: | September 2010 |
| End Date: | May 2012 |
| Contact: | Stephen Page, PhD |
| Email: | stephen.page@uc.edu |
| Phone: | 513-558-2754 |
Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke
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.
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.
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.
We found this trial at
1
site
Click here to add this to my saved trials
