Robotic Training for Stroke Neurorehabilitation
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02639390 |
|
Recruitment Status :
Recruiting
First Posted : December 24, 2015
Last Update Posted : September 17, 2019
|
Sponsor:
VA Office of Research and Development
Information provided by (Responsible Party):
VA Office of Research and Development
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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. 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Stroke | Device: Robotic Therapy Other: Conventional Therapy | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 38 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Task-Specific Upper-Extremity Robotic Training for Stroke Neurorehabilitation |
| Actual Study Start Date : | May 7, 2018 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Robotic
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.
|
Device: Robotic Therapy
Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects. Other: Conventional Therapy 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. |
|
Active Comparator: Conventional
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).
|
Other: Conventional Therapy
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. |
Primary Outcome Measures :
- 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.
Information from the National Library of Medicine
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639390
Contacts
| Contact: Rahsaan Holley, MS | (202) 877-1875 | rahsaan.holley@medstar.net |
Locations
| United States, District of Columbia | |
| Washington DC VA Medical Center, Washington, DC | Recruiting |
| Washington, District of Columbia, United States, 20422 | |
| Contact: Delphyne Bruner 202-745-8328 Delphyne.Bruner@va.gov | |
| Principal Investigator: Peter S. Lum, PhD | |
Sponsors and Collaborators
VA Office of Research and Development
Investigators
| Principal Investigator: | Peter S. Lum, PhD | Washington DC VA Medical Center, Washington, DC |
| Responsible Party: | VA Office of Research and Development |
| ClinicalTrials.gov Identifier: | NCT02639390 History of Changes |
| Other Study ID Numbers: |
A1966-R |
| First Posted: | December 24, 2015 Key Record Dates |
| Last Update Posted: | September 17, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
| Product Manufactured in and Exported from the U.S.: | No |
Keywords provided by VA Office of Research and Development:
|
Robotics upper extremity neurorehabilitation movement therapy |
Additional relevant MeSH terms:
|
Stroke Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases |