Extension of the MIME Robotic System for Stroke Rehabilitation

Completed

Phase 2 Results

Update History

18 Feb '14
The Summary of Purpose was updated.
New
The goal of this project is to develop and test a new robotic system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME robot is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.
Old
The goal of this project is to further develop the MIME system to accommodate practice of tasks requiring reach, grasp and release of objects. Our previous work has shown that the MIME is safe and effective for improving reach in stroke subjects. But adequate control of hand movements is critical to a functional upper limb, and is often resistant to conventional therapeutic interventions. Many stroke survivors have residual ability to flex the fingers, but extension is often limited and impeded by increased passive stiffness in flexors, abnormal levels of increased tone in flexors and weakness in extensors. In a recent study, 38% of stroke survivors reported that impaired hand function was the most disabling motor impairment they faced.
The description was updated.
New
Research Design: We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after robotic training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after robotic training will be greater than after dose-matched conventional therapy. Methodology: In the first year of the study, we will develop a robotic system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the ARMin III arm exoskeleton so that tasks such as arm reach, grasp of an object and release of the object can be trained. In the last 2 years of the project, we will perform a pilot clinical trial comparing this new training paradigm to dose-matched conventional therapy in chronic stroke survivors. Outcome measures will be taken before training and immediately after training.
Old
Research Design: We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after MIME training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after MIME training will be greater than after dose-matched conventional therapy; 3) Unlike in previous studies, gains in both proximal arm and hand function at the 6-month followup will be greater after MIME training than after dose-matched conventional therapy. Methodology: In the first year of the study, we will extend the current MIME system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the current MIME system so that tasks such as arm reach, grasp of an object and release of the object can be trained. All of the training modes currently available for reaching movements will be extended to hand function. In the last 2 years of the project, we will perform a pilot clinical trial with 30 subjects comparing this new training paradigm to dose-matched conventional therapy in subacute and chronic stroke survivors. Outcome measures will be taken before training, immediately after training.
2 Nov '13
The eligibility criteria were updated.
New
Inclusion Criteria: - An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study; - trace ability to move the wrist and fingers in extension; - voluntary shoulder elevation to approximately 45 deg; - be between the ages of 21 and 90. Exclusion Criteria: - Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988); - have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols; - have an upper extremity injury or conditions prior to stroke that could limit participation; - have severes hemispatial neglect. - have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and - have severe sensory loss.
Old
Inclusion Criteria: 1. An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study; 2. trace ability to move the wrist and fingers in extension; 3. voluntary shoulder elevation to approximately 45 deg; 4. be between the ages of 21 and 90. Exclusion Criteria: 1. Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988); 2. have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols; 3. have an upper extremity injury or conditions prior to stroke that could limit participation; 4. have severes hemispatial neglect. 5. have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and 6. have severe sensory loss.
27 Sep '12
The description was updated.
New
Research Design: We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after MIME training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after MIME training will be greater than after dose-matched conventional therapy; 3) Unlike in previous studies, gains in both proximal arm and hand function at the 6-month followup will be greater after MIME training than after dose-matched conventional therapy. Methodology: In the first year of the study, we will extend the current MIME system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the current MIME system so that tasks such as arm reach, grasp of an object and release of the object can be trained. All of the training modes currently available for reaching movements will be extended to hand function. In the last 2 years of the project, we will perform a pilot clinical trial with 30 subjects comparing this new training paradigm to dose-matched conventional therapy in subacute and chronic stroke survivors. Outcome measures will be taken before training, immediately after training.
Old
Research Design: We hypothesize that: 1) Gains in proximal arm function (shoulder, elbow) immediately after MIME training will be greater than after dose-matched conventional therapy; 2) Unlike in previous studies, gains in hand function immediately after MIME training will be greater than after dose-matched conventional therapy; 3) Unlike in previous studies, gains in both proximal arm and hand function at the 6-month followup will be greater after MIME training than after dose-matched conventional therapy. Methodology: In the first year of the study, we will extend the current MIME system with the ability to assist hand movement. Since many stroke survivors in the subacute and chronic recovery stages have residual ability to flex the fingers but severely limited finger extension, we will build a hand exoskeleton that can apply precise extension forces to the digits of the hand. This exoskeleton will be integrated with the current MIME system so that tasks such as arm reach, grasp of an object and release of the object can be trained. All of the training modes currently available for reaching movements will be extended to hand function. In the last 2 years of the project, we will perform a pilot clinical trial with 30 subjects comparing this new training paradigm to dose-matched conventional therapy in subacute and chronic stroke survivors. Outcome measures will be taken before training, immediately after training and at 6 months post training.
The eligibility criteria were updated.
New
Inclusion Criteria: 1. An ischemic or hemorrhagic stroke more than 6 months prior to entry into the study; 2. trace ability to move the wrist and fingers in extension; 3. voluntary shoulder elevation to approximately 45 deg; 4. be between the ages of 21 and 90. Exclusion Criteria: 1. Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988); 2. have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols; 3. have an upper extremity injury or conditions prior to stroke that could limit participation; 4. have severes hemispatial neglect. 5. have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and 6. have severe sensory loss.
Old
Inclusion Criteria: 1. An ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 12 months of entry to the study; 2. trace ability to move the wrist and fingers in extension; 3. persistent hemiparesis, as indicated by a score of 1 or 2 on the motor arm item of the NIH stroke scale (NIHSS, Goldstein 1989); and 4. be between the ages of 21 and 90. Exclusion Criteria: 1. Have cognitive deficits that could negatively affect their ability to complete protocols as evidenced by a score of 24 or less on the Folstein Mini - Mental State Examination (Bleeker, 1988); 2. have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols; 3. have an upper extremity injury or conditions prior to stroke that could limit participation; 4. have hemispatial neglect as determined by > three errors on the Star Cancellation Test (Halligan 1990); 5. have a full score of 24 on the distal section of the Fugl-Myer test (FM) (Fugl-Meyer 1975); and 6. have severe sensory loss as determined by a score of 2 on the sensory item of the NIH Stroke Scale (Goldstein 1989).
26 Jan '12
A location was updated in Washington.
New
The overall status was removed for VA Medical Center, DC.