StrokePhase 2NCT02639390
Robotic Training for Stroke Neurorehabilitation
A Phase 2 study testing Robotic Therapy and Conventional Therapy in people with Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm function after stroke. The investigators previously developed a novel training protocol that combined the ARMin and HandSOME exoskeletons. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Robotic Therapy and Conventional Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2018to 31 Dec 2019
- Phase
- Phase 2
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 or older
- Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) that occurred more than 6 months before entering the study
- Presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
- Adequate cognitive status, as determined by clinical evaluation
- No upper extremity injury or conditions that limited use prior to the stroke
Who cannot join
- Cannot give informed consent
- Have clinically significant fluctuations in mental status within a month of enrollment
- Were not independent prior to the stroke as measured by scores <95 on the Barthel Index or >1 on the Modified Rankin Scale
- Have hemispatial neglect as determined by >3 errors on the Star Cancellation Test
- Have severe sensory loss as determined by a score of 2 on the sensory item of the NIHSS
- Receiving oral or injected antispasticity medications during study treatment
- Pain that interferes with daily activities
- History of prior stroke
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: Task-Specific Upper-Extremity Robotic Training for Stroke Neurorehabilitation
The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm function after stroke. The investigators previously developed a novel training protocol that combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons that allow coordinated whole limb training in reach and grasp tasks with both virtual and real objects. However, the robot has a very large inertia and friction, and only gross grasp patterns are available. In development work, the investigators will significantly modify the AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of retraining a wide range of functional activities. In the subsequent testing phase, a clinical trial will examine the effects of robotic training in chronic stroke subjects.
Read the detailed description
In a pilot clinical trial, the investigators found that the current robotic exoskeleton elicited improvements in arm function that can potentially supplement conventional methods to improve outcomes. However, the robot has a very large inertia and friction, and only gross grasp patterns are available. Therefore, improvements in movement speed and fine grasp were limited after robotic training. In development work, the investigators will significantly modify the ARMin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of retraining a wide range of functional activities. The investigators will reduce the inertia and friction of the robot to 1/4 of current values, incorporate an adaptive algorithm to automatically adjust assistance levels and extend the range of grasp patterns to include power grasp, thumb-index finger pinch and key pinch. Using the improved device from the development activities, the investigators will perform a clinical trial to compare the effectiveness of robotic training to conventional therapy from an occupational therapist. To take advantage of the facilitatory effect of robot therapy on subsequent conventional therapy, the experimental treatment will be 12 hours of robot therapy followed by 12 hours of conventional therapy. Chronic stroke subjects (N=38) will be randomly assigned to receive this experimental treatment or 24 hours of conventional therapy from an occupational therapist.
- Conditions
- Stroke
- Being tested
- Robotic Therapy, Conventional Therapy
- Keywords
- Robotics, upper extremity, neurorehabilitation, movement therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic TherapyDevice
Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.
Conventional TherapyOther
An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Experimental | The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist. Receives: Device: Robotic Therapy; Other: Conventional Therapy |
| Conventional | Active comparator | Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week). Receives: Other: Conventional Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fugl-Meyer Score
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
Measured: Change from baseline to 8 weeks
Change in Action Research Arm Test
The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.
Measured: Change from baseline to 8 weeks
Change in Motor Activity Log
The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.
Measured: Change from baseline to 8 weeks
Change in Fugl-Meyer Score at Follow-up
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
Measured: Change from baseline to 8 months
Change in Action Research Arm Test at Follow-up
The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.
Measured: Change from baseline to 8 months
Change in Motor Activity Log at Follow-up
The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.
Measured: Change from baseline to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study start7 May 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Why it stopped: Administrative challenges made it impossible to recruit enough subjects to achieve the study goals.
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 StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Peter S. Lum, PhD, Principal investigator, Washington DC VA Medical Center, Washington, DC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639390
- Sponsor's protocol ID
- A1966-R
- Status last verified
- Dec 2020
- First submitted
- 15 Dec 2015
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-Specific Upper-Extremity Robotic Training for Stroke Neurorehabilitation
- ClinicalTrials.gov ID
- NCT02639390
- Acronym / sponsor ID
- A1966-R
- Conditions
- Stroke
- Keywords
- Robotics, upper extremity, neurorehabilitation, movement therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative challenges made it impossible to recruit enough subjects to achieve the study goals.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 7 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Dec 2015 (estimated)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal is to further develop a robotic exoskeleton for neurorehabilitation of arm function after stroke. The investigators previously developed a novel training protocol that combined the ARMin and HandSOME exoskeletons. This is one of only a few arm exoskeletons that allow coordinated whole limb training in reach and grasp tasks with both virtual and real objects. However, the robot has a very large inertia and friction, and only gross grasp patterns are available. In development work, the investigators will significantly modify the AMRin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of retraining a wide range of functional activities. In the subsequent testing phase, a clinical trial will examine the effects of robotic training in chronic stroke subjects.
Detailed description
In a pilot clinical trial, the investigators found that the current robotic exoskeleton elicited improvements in arm function that can potentially supplement conventional methods to improve outcomes. However, the robot has a very large inertia and friction, and only gross grasp patterns are available. Therefore, improvements in movement speed and fine grasp were limited after robotic training. In development work, the investigators will significantly modify the ARMin and HandSOME to deliver a state-of-the-art lightweight robotic exoskeleton capable of retraining a wide range of functional activities. The investigators will reduce the inertia and friction of the robot to 1/4 of current values, incorporate an adaptive algorithm to automatically adjust assistance levels and extend the range of grasp patterns to include power grasp, thumb-index finger pinch and key pinch. Using the improved device from the development activities, the investigators will perform a clinical trial to compare the effectiveness of robotic training to conventional therapy from an occupational therapist. To take advantage of the facilitatory effect of robot therapy on subsequent conventional therapy, the experimental treatment will be 12 hours of robot therapy followed by 12 hours of conventional therapy. Chronic stroke subjects (N=38) will be randomly assigned to receive this experimental treatment or 24 hours of conventional therapy from an occupational therapist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic | Experimental | Device: Robotic Therapy, Other: Conventional TherapyThe experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist. |
| Conventional | Active comparator | Other: Conventional TherapySubjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week). |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 21 or older
- Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) that occurred more than 6 months before entering the study
- Presence of voluntary hand activity indicated by a score of at least 1 on the finger mass extension/grasp release item of the Fugl-Meyer Test of Motor Function
- Adequate cognitive status, as determined by clinical evaluation
- No upper extremity injury or conditions that limited use prior to the stroke
Key exclusion criteria (8 listed)
- Cannot give informed consent
- Have clinically significant fluctuations in mental status within a month of enrollment
- Were not independent prior to the stroke as measured by scores <95 on the Barthel Index or >1 on the Modified Rankin Scale
- Have hemispatial neglect as determined by >3 errors on the Star Cancellation Test
- Have severe sensory loss as determined by a score of 2 on the sensory item of the NIHSS
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 |
|---|---|---|
| Robotic TherapySubjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects. | Device | Robotic |
| Conventional TherapyAn occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement. | Other | Conventional, Robotic |
Primary outcome
Change in Fugl-Meyer Score
Time frame: Change from baseline to 8 weeks
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
Change in Action Research Arm Test
Time frame: Change from baseline to 8 weeks
The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.
Change in Motor Activity Log
Time frame: Change from baseline to 8 weeks
The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.
Change in Fugl-Meyer Score at Follow-up
Time frame: Change from baseline to 8 months
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
Change in Action Research Arm Test at Follow-up
Time frame: Change from baseline to 8 months
The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.
Change in Motor Activity Log at Follow-up
Time frame: Change from baseline to 8 months
The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Foot Drop Rehabilitation and Mobility in Chronic Stroke
Stroke
Enrolling by invitation
Study on the Efficacy and Safety of Non-Invasive Brain-Computer Interface With MRI-Guided Multi-Channel Time-Domain Interference Stimulation in Treating Motor Dysfunction in Acute Cerebral Infarction Patients
Acute Ichemic Stroke
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
Enrolling by invitation
Long-Term Clinical, Health Economic, and Process Evaluation of Intensive Technology-Integrated Motor Rehabilitation in Chronic Neurological Conditions (INTeRAcT-bis)
Stroke, Spinal Cord Injuries (SCI)
Not yet recruitingPhase 2
Rimonabant for Improving Walking Ability in Patients With Chronic Stroke
Chronic Stroke
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.
Peter S. Lum, PhD principal investigator
Washington DC VA Medical Center, Washington, DC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Robotic Therapy and Conventional Therapy in people with Stroke, run by VA Office of Research and Development 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 8 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: stopped early, as of the sponsor's last update on 13 Jan 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2020). 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?
Change in Fugl-Meyer Score (time frame: Change from baseline to 8 weeks). 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 13 Jan 2021.