Phase 2
N=12
Extension of the MIME Robotic System for Stroke Rehabilitation
Stroke · Impaired Upper Extremity Function
Bottom Line
View on ClinicalTrials.gov: NCT00995774 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Fugl-Meyer Test of Motor Function — 1.9; .8; 1.3; .8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- robotic therapy (Device); conventional functional training (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- May 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer Test of Motor Function |
1.9; .8; 1.3; .8; 1.6; 1.6 | — |
| SECONDARY Action Research Arm Test |
4.6; -.2; .4; 0; -2; 1.4 | — |
| SECONDARY A Motion Analysis Evaluation Will be Performed on Reach and Grasp Tasks. The Kinematics Will be Measured Using an Electromagnetic Tracker (Flock of Birds, Ascension Technology Corp., Burlington VT). |
— | — |
Summary
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.
Eligibility Criteria
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 severe 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.
Data sourced from ClinicalTrials.gov (NCT00995774). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.