Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke
|ClinicalTrials.gov Identifier: NCT01322997|
Recruitment Status : Unknown
Verified March 2011 by University of Cincinnati.
Recruitment status was: Recruiting
First Posted : March 25, 2011
Last Update Posted : March 25, 2011
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 or disease||Intervention/treatment||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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke|
|Study Start Date :||September 2010|
|Estimated Primary Completion Date :||May 2012|
|Estimated Study Completion Date :||May 2012|
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.
- 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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01322997
|Contact: Stephen Page, PhDfirstname.lastname@example.org|
|United States, Ohio|
|Univcersity of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45267|
|Contact: Stephen Page, PhD 513-558-2754 email@example.com|
|Principal Investigator: Stephen Page, PhD|