HemiparesisNCT01654315
Robotic Brace Incorporating Electromyography for Moderate Affected Arm Impairment After Stroke
A study testing Myomo Robotic Arm and RTP Standard Therapy in people with Hemiparesis, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Myomo Robotic Arm and RTP Standard Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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)
- 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.)
- 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.)
- 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.)
- 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.).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke
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.
Read the 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), 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,than subjects in the other groups at POST. These differences will be sustained at POST-2.
- Conditions
- Hemiparesis
- Being tested
- Myomo Robotic Arm, RTP Standard Therapy
- Keywords
- RTP Only Group, Myomo Only Group, Myomo + RTP Group
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myomo Robotic ArmDevice
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.
RTP Standard TherapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: RTP Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
The Arm Motor Activity Test (AMAT) was the secondary outcome for this study and was used to determine whether changes occur in activity limitation. The AMAT is a 13-item test in which valued activities are rated according to a functional ability scale that examines affected limb use 0 = no use, 1 = very slight use, 2 = slight use, 3 = moderate use, 4 = almost normal use, 5 = normal use;) and a Quality of Movement Scale (0 = no use, 1 = very poor, 2 = poor, 3 = fair, 4 = almost normal, 5 = normal. ). Therefore, the highest score that one can attain on either scale is 65.0 (which would mean that the person scored a perfect score of "5" on each of the thirteen items).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startMar 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Page, PhD,M.S., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654315
- Sponsor's protocol ID
- 2011H0215
- Status last verified
- Feb 2022
- First submitted
- 16 May 2012
- Last updated
- 7 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Brace Incorporating EMG for Moderate Affected Arm Impairment After Stroke
- ClinicalTrials.gov ID
- NCT01654315
- Acronym / sponsor ID
- 2011H0215
- Conditions
- Hemiparesis
- Keywords
- RTP Only Group, Myomo Only Group, Myomo + RTP Group
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Posted 4 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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), 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,than subjects in the other groups at POST. These differences will be sustained at POST-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental: Myomo Only Group | Experimental | Device: Myomo Robotic ArmExperimental: 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. |
| Experimental: Myomo + RTP Group | Experimental | Device: Myomo Robotic ArmExperimental: 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. |
| Active Comparator: RTP Group | Active comparator | Behavioral: RTP Standard TherapyActive 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myomo Robotic ArmPatients 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. | Device | Experimental: Myomo + RTP Group, Experimental: Myomo Only Group |
| RTP Standard TherapyActive 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. | Behavioural | Active Comparator: RTP Group |
Primary outcome
Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale.
Time frame: 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
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).
1 secondary outcome
Arm Motor Ability Test (AMAT)
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hemiparesis
Not yet recruiting
Dynamic Stabilometry Combined With Transcranial Direct Current Stimulation for Balance and Motor Recovery After Ischemic Stroke
Hemiparesis, Ischemic Stroke
Active, not recruiting
Stimulation Combined With Powered Motorized Orthoses for Walking After Stroke
Stroke, Hemiparesis
Recruiting
Telerehabilitation for Post-Stroke Hand Function
Stroke
RecruitingObservational study
Kinematic Analysis of Manual Dexterity
Down Syndrome, Hemiparesis
Not yet recruiting
Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).
Hemiplegia, Hemiparesis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Page, PhD,M.S. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myomo Robotic Arm and RTP Standard Therapy in people with Hemiparesis, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impairment in the Affected Upper Extremity as Measured by the Fugl Meyer Scale. (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.