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

NCT01322997 | Unknown Phase 1

• 1 other identifier: 1R03HD062545-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Myomo + RTP

EXPERIMENTAL

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

Myomo

ACTIVE COMPARATOR

Patients in this group will only be administered the robotic brace described elsewhere in this record.

Device: Myomo e100 neurorobotic brace

RTP only

ACTIVE COMPARATOR

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

Interventions

Myomo e100 Robot and repetitive task specific training DEVICE

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.

Myomo + RTP

Repetitive task specific training (RTP) targeting the affected arm BEHAVIORAL

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.

RTP only

Myomo e100 neurorobotic brace DEVICE

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.

Myomo

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

Univcersity of Cincinnati

Cincinnati, Ohio, 45267, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

N-myc downstream-regulated gene 1 protein

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Stephen Page, PhD

CONTACT

513-558-2754; stephen.page@uc.edu

Study Design

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

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 25, 2011
• Study Start: September 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 25, 2011

Record last verified: 2011-03

Locations

US (1)