Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Stephen Page, Ohio State University
ClinicalTrials.gov Identifier:
NCT01654315
First received: May 16, 2012
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

Of the 5.7 million stroke survivors in the United States, up to 80% exhibit significant weakness in one arm (called "hemiparesis"). This devastating impairment undermines performance of valued activities and quality of life. Although rehabilitation is commonly provided, conventional affected arm rehabilitative strategies have negative evidence, or no evidence, supporting their use. Thus, there remains a need for evidence-based rehabilitative strategies for arm hemiparesis.

Newer rehabilitative approaches emphasize repetitive, task-specific practice (RTP) incorporating the affected arm. However, many of these promising regimens require participation in intensive therapies, and most are only efficacious on the least impaired patients. Thus, there remains a need for an efficacious, practical RTP technique to address moderate affected arm hemiparesis.

To address the above shortfalls, one of the investigators team members piloted an innovative brace integrating electromyography (EMG) and robotics. In his case series, 8 stroke patients exhibiting moderate arm impairment successfully participated in RTP, with the brace (called the "Myomo") detecting and augmenting their movement attempts. Aided by the Myomo, participation in the RTP regimen reduced subjects' affected arm impairment and spasticity. The next logical step is to test Myomo + RTP efficacy using randomized controlled methods and an appropriate sample size.


Condition Intervention Phase
Hemiparesis
Device: Myomo Robotic Arm
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Movement in the affected upper extremity as measured by the Fugl Meyer Test. [ Time Frame: 2-3 weeks before intervention; 1 week after intervention; 2 months post intervention ] [ Designated as safety issue: No ]
    The upper extremity section of the Fugl-Meyer Scale (FM)35 will assess whether changes occur in upper extremity impairment. The FM has been used extensively in stroke recovery studies, and is highly recommended for "use in clinical trials designed to evaluate changes in motor impairment following stroke."


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Experimental: Myomo Only Group
Experimental: Myomo Only Group Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.
Device: Myomo Robotic Arm
Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.
Experimental: Experimental: Myomo + RTP Group
Experimental: Myomo + RTP Group Patients are administered rehabilitative therapy using both the Myomo robotic device and RTP targeting their affected arms on 3 days/week during a 8 week period.
Device: Myomo Robotic Arm
Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.
Active Comparator: Active Comparator: RTP Group
Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period.
Device: Myomo Robotic Arm
Patients are administered rehabilitative therapy using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period.

Detailed Description:

The primary objective of this small efficacy study is to collect randomized, controlled pilot data estimating clinical effectiveness of this combined, EMG/robotics approach in conjunction with RTP. A unique adjunct will be acquisition of biomechanical data as an outcome measure. Based on pilot data, the central hypothesis is that Myomo therapy with RTP will exhibit significant impairment reductions. We will test the central hypothesis and accomplish the objective by pursuing the following specific aims:

Specific Aim 1: Compare efficacy of Myomo + RTP with RTP only and Myomo only on affected arm impairment. Thirty stroke patients exhibiting moderate affected arm deficits will be randomly assigned to receive: (a) Myomo combined with RTP (Myomo + RTP); (b) RTP only (RTP), which constitutes the most frequently used regimen in clinical environments;2,3 or (c) Myomo therapy only (Myomo). The current study design will determine the additive effect of Myomo training to RTP, while also discerning the relative efficacy of RTP only or Myomo use only. The intended duration of contact will be equivalent across groups.

Affected arm impairment, the primary study outcome, will be measured by the upper extremity section of the Fugl-Meyer Impairment Scale (FM), the primary outcome measure. The FM will be administered by a blinded rater twice before intervention, immediately post-intervention (POST), and two months post-intervention (POST-2) with POST serving as the primary study endpoint. The primary study hypothesis is that subjects in the Myomo + RTP group will exhibit significantly larger FM score changes than Myomo or RTP subjects at POST. It is also hypothesized that these changes will be sustained at POST-2.

Specific Aim 2: Determine the impact of Myomo + RTP on affected arm outcomes. The investigators will administer the Arm Motor Ability Test (AMAT), the Motor Activity Log (MAL), and the Stroke Impact Scale (SIS) to all subjects before intervention, at POST, and at POST-2. When compared to their scores before intervention, it is hypothesized that Myomo + RTP subjects will exhibit significantly larger AMAT score changes, significantly larger score changes on the Amount of Use Scale of the MAL, larger score changes on the Quality of Movement scale of the MAL, and larger SIS score changes, than subjects in the other groups at POST. These differences will be sustained at POST-2.

Specific Aim 3: Estimate the effect of Myomo + RTP on movement kinematics. Using a kinematic protocol validated by our team,4 we will conduct movement performance experiments on a subset of patients from each of the three groups. Specifically, 5 patients from each group (n=15) will be administered reaching kinematics before intervention and at POST. Kinematic data are expected to identify specific movement parameters that are affected by stroke, and how each intervention impacts these movement parameters (e.g. reach path; rate of force production).

Traditional, rater based, outcome measures may be less able to discern subtle motor changes exhibited by more impaired stroke subjects. Inclusion of kinematic data in our study design will overcome this potential challenge within our sample.

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. upper extremity Fugl Meyer score >10-< 25 (i.e., subject must score between (and including) 10 and 25 on the UE FM at the baseline screening appointment only)
  2. presence of volitionally activated EMG signal from the paretic biceps brachii of at least 5 ųV in amplitude
  3. stroke experienced > 1 month prior to study enrollment
  4. a score > 24 on the Folstein Mini Mental Status Examination (MMSE)
  5. age > 35 < 85
  6. have experienced one stroke
  7. discharged from all forms of physical rehabilitation
  8. 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).
  9. < 35 years old
  10. excessive pain in the affected hand, arm or shoulder, as measured by a score > 5 on a 10-point visual analog scale
  11. excessive spasticity at the affected elbow, as defined as a score of > 4 on the Modified Ashworth Spasticity Scale
  12. currently participating in any experimental rehabilitation or drug studies
  13. apraxia (< 2.5 on the Alexander scale)
  14. severe sensory loss in affected hand (Nottingham sensory scale at least 75% of normal)
  15. severe language deficits (score < 2 on NIH Stroke Scale question 9)
  16. Stroke that occurred in the brainstem (corticospinal tracts are the final pathway for the motor system, and are frequently damaged in brainstem strokes. These individuals are hypothesized to be less likely to benefit from the cortical plasticity seen with exercise therapy, and are therefore excluded from this study.)
  17. A current medical history of uncontrolled cardiovascular, or pulmonary disease, or other disease that would preclude involvement in a therapeutic treatment (Subjects must be able to tolerate a one-hour upper-extremity therapy session.)
  18. History of neurological disorder other than stroke (other neurological disorders may affect the upper extremity motor performance of subjects.); (11) Other significant pain or skin irritation in the upper extremity that would be exacerbated if by the use of the brace (While wearing the brace, the system is pressed close to the upper arm and strapped around it. (If the subject suffers from dermal breakdown or other skin conditions that may be aggravated by such a situation, they should not be involved in the study.)
  19. Substantial contracture of elbow, defined as > 20 degrees of elbow flexion, as measured at the baseline evaluation. (The system cannot work in the presence of reduced range of motion due to contractures.).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654315

Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Stephen Page, PhD,M.S. Ohio State University
  More Information

No publications provided

Responsible Party: Stephen Page, Associate Professor School of Health and Rehabilitation Sciences Division of Occupational Therapy Affiliation: Ohio State University, Ohio State University
ClinicalTrials.gov Identifier: NCT01654315     History of Changes
Other Study ID Numbers: 2011H0215
Study First Received: May 16, 2012
Last Updated: May 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University:
RTP Only Group
Myomo Only Group
Myom0 + RTP Group

Additional relevant MeSH terms:
Paresis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014