CVA (Cerebrovascular Accident)NCT00396708
Wearable Robotic Functional Assistance for Stroke Rehabilitation
A study testing myomo e100 neurorobotic elbow brace in people with CVA (Cerebrovascular Accident), run by Myomo at 1 site in United States.
Trial summary
This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CVA (Cerebrovascular Accident)
- What is being tested?
- myomo e100 neurorobotic elbow brace
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically Stable
- Cognitive Awareness
- Weakness in upper arm
- Over 1 year post CVA
- not engaged in any other upper arm therapies
Who cannot join
- Rashes, open wounds or skin sensitivity on arm
- Very high elbow tone (arm rigid in flexion or extension)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.
Read the detailed description
This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.
The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.
Study procedures will focus on performing functional tasks using the e100.
- Conditions
- CVA (Cerebrovascular Accident)
- Being tested
- myomo e100 neurorobotic elbow brace
- Keywords
- Robotics, Rehabilitation, Arm, Stroke, Weakness, Outpatient, Chronic
- Medical subject headings
- Stroke, Asthenia, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myomo e100 neurorobotic elbow braceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Activity Log
Fugl-Meyer Upper Arm Function
Wolf Motor Function
SF-36 QOL Survey
Range of Motion
Muscle Strength Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CVA (Cerebrovascular Accident)Studies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myomo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Kailas N Narendran, BS, MEng, Principal investigator, Inventor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396708
- Sponsor's protocol ID
- 1
- Status last verified
- Feb 2010
- First submitted
- 3 Nov 2006
- Last updated
- 3 Feb 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Robotic Functional Assistance for Stroke Rehabilitation
- ClinicalTrials.gov ID
- NCT00396708
- Acronym / sponsor ID
- 1
- Conditions
- CVA (Cerebrovascular Accident)
- Keywords
- Robotics, Rehabilitation, Arm, Stroke, Weakness, Outpatient, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- MyomoIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Dec 2007 (actual)
- First posted
- 7 Nov 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effectiveness of using the myomo e100 wearable robotic rehabilitation system for increasing functional independence and long term rehabilitation of chronic stroke victims with a hemiparetic upper extremity.
Detailed description
This is a case controlled study for evaluation of the effectiveness of using the myomo e100 wearable robotic rehabilitation for upper arm therapy following stroke.
The intervention for the study will be for the control group- 6-8 weeks of therapeutic exercise and functional training for a total of 18 hours of intervention, or the case group- 6-8 weeks of therapeutic exercise and functional training with the use of the AJB for a total of 18 hours of intervention. Each session will be one hour in length. The length of the study and length of each session is per standard rehabilitation protocol that has been well documented in previous studies as well as the pilot study regarding the AJB. A pre and post test with a 3 month follow up of all measures will be included in the study.
Study procedures will focus on performing functional tasks using the e100.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically Stable
- Cognitive Awareness
- Weakness in upper arm
- Over 1 year post CVA
- not engaged in any other upper arm therapies
Key exclusion criteria (2 listed)
- Rashes, open wounds or skin sensitivity on arm
- Very high elbow tone (arm rigid in flexion or extension)
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 e100 neurorobotic elbow brace | Device | – |
Primary outcome
Motor Activity Log
Fugl-Meyer Upper Arm Function
Wolf Motor Function
SF-36 QOL Survey
Range of Motion
Muscle Strength Test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2010.
- Myomo Inc. HomepageLink provided by the sponsor.
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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.
Kailas N Narendran, BS, MEng principal investigator
Inventor
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 e100 neurorobotic elbow brace in people with CVA (Cerebrovascular Accident), run by Myomo 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 5 inclusion and 2 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 3 Feb 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Motor Activity Log. The study lists 6 primary outcomes in all. 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 3 Feb 2010.