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

Primary Purpose

Stroke

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Myomo e100 Robot and repetitive task specific training
Repetitive task specific training (RTP) targeting the affected arm
Myomo e100 neurorobotic brace
Sponsored by
University of Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Univcersity of CincinnatiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Myomo + RTP

Myomo

RTP only

Arm Description

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.

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

Patients in this group will be administered repetitive task specific practice (RTP), emphasizing use of their affected arms during performance of valued, functional tasks.

Outcomes

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 16, 2011
Last Updated
March 23, 2011
Sponsor
University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01322997
Brief Title
Robotic Brace Incorporating Electromyography (EMG) for Moderate Affected Arm Impairment After Stroke
Official Title
Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2012 (Anticipated)
Study Completion Date
May 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Myomo + RTP
Arm Type
Experimental
Arm Description
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.
Arm Title
Myomo
Arm Type
Active Comparator
Arm Description
Patients in this group will only be administered the robotic brace described elsewhere in this record.
Arm Title
RTP only
Arm Type
Active Comparator
Arm Description
Patients in this group will be administered repetitive task specific practice (RTP), emphasizing use of their affected arms during performance of valued, functional tasks.
Intervention Type
Device
Intervention Name(s)
Myomo e100 Robot and repetitive task specific training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Repetitive task specific training (RTP) targeting the affected arm
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Myomo e100 neurorobotic brace
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Twice before intervention; once after intervention; 2 months after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Page, PhD
Phone
513-558-2754
Email
stephen.page@uc.edu
Facility Information:
Facility Name
Univcersity of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Page, PhD
Phone
513-558-2754
Email
stephen.page@uc.edu
First Name & Middle Initial & Last Name & Degree
Stephen Page, PhD

12. IPD Sharing Statement

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

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