Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke

NCT01654315 | Completed Results

• 1 other identifier: 2011H0215
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiparesis

Keywords

RTP Only Group; Myomo Only Group; Myomo + RTP Group

Outcome Measures

Primary Outcomes (1)

• Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale.

  The upper extremity section of the Fugl-Meyer Scale (FM) will assess whether changes occur in paretic upper extremity motor 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." The items on the measure require the subject to perform various movements with the affected upper extremity, and each item is scored from 0 (cannot perform) to 2 (performs normally). Item are then summed for a total score. The total score ranges are 0 to 66, with a higher score representing less upper extremity impairment (and, thus, a relatively "better" score on the measure than a lower score).

  Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention

Secondary Outcomes (1)

• Arm Motor Ability Test (AMAT)

  Administered twice before the intervention period. These two scores are averaged to provide a composite score that is compared to average score for each group that is collected 1 week after intervention

Study Arms (3)

Experimental: Myomo Only Group

EXPERIMENTAL

Experimental: Myomo Only Group Patients are administered rehabilitative therapy known as "repetitive task specific practice" (RTP) using only the Myomo robotic device targeting their affected arms on 3 days/week, in 1/2 hour increments, during an 8-week period.

Device: Myomo Robotic Arm

Experimental: Myomo + RTP Group

EXPERIMENTAL

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 in 1/2 hour increments, during an 8 week period. These patients engage in activities that emphasize use of their affected arms repetitively, with the device providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the device during the activities is reduced.

Device: Myomo Robotic Arm

Active Comparator: RTP Group

ACTIVE COMPARATOR

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. In this condition, patients engage in activities that emphasize use of their affected arms repetitively, with the therapist providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the therapist during the activities is reduced.

Behavioral: RTP Standard Therapy

Interventions

Myomo Robotic Arm DEVICE

Patients are administered rehabilitative therapy (repetitive task specific therapy,, also known as "RTP' in this study) using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. These patients engage in RTP, which consists of a battery of activities that emphasize use of their affected arms repetitively, with the device providing assistance as needed with movement through the arm's range of motion.

Experimental: Myomo + RTP Group; Experimental: Myomo Only Group

RTP Standard Therapy BEHAVIORAL

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. In this condition, patients engage in activities that emphasize use of their affected arms repetitively, with the therapist providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the therapist during the activities is reduced.

Active Comparator: RTP Group

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 (i.e., subject must score between (and including) 10 and 25 on the UE FM at the baseline screening appointment only)
• 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).
• \< 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)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Stephen Page
• Organization: The Ohio State University

STEPHEN.PAGE@OSUMC.EDU

614-292-5490

Study Officials

• Stephen Page, PhD,M.S.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: July 31, 2012
• Study Start: March 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 7, 2022
• Results First Posted: June 4, 2019

Record last verified: 2022-02

Locations

US (1)