Stroke Clinical Trial
Official title:
Pilot Study of the Effects of Protocol-Specific Robotic Arm Therapy in Stroke Recovery
Verified date | February 2018 |
Source | Northwell Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to determine if tailoring multiple sessions of upper extremity robotic therapy to focus on a particular aspect of movement (e.g smoothness vs. aiming; active range of motion vs. functional practice)can optimize therapeutic results and lead to greater functional returns in arm mobility after stroke.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 18 years of age or older - First single focal unilateral lesion with diagnosis verified by brain imaging, which occurred at least 6 months prior - Cognitive function sufficient enough to understand experiments and follow instructions - Fugl Meyer assessment at admission of 7 to 38 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist) Exclusion Criteria: - Prior experience with robotic arm therapy - Fixed contraction of the affected limb - Complete flaccid paralysis of the affected limb |
Country | Name | City | State |
---|---|---|---|
United States | Feinstein Institute for Medical Research | Manhasset | New York |
Lead Sponsor | Collaborator |
---|---|
Northwell Health |
United States,
Stein J, Krebs HI, Frontera WR, Fasoli SE, Hughes R, Hogan N. Comparison of two techniques of robot-aided upper limb exercise training after stroke. Am J Phys Med Rehabil. 2004 Sep;83(9):720-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in Upper Extremity Fugl Meyer Motor Assessment | 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) | ||
Secondary | Change from baseline in Kinematic Data | Kinematic Data recorded during therapy with IMT robots | 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) | |
Secondary | Change from baseline in Fugl Meyer Sensation Scale | 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) | ||
Secondary | Change from baseline in Fugl Meyer Proprioception Scale | 12 weeks (immediately following the intervention) and 24 weeks (3 months after the intervention) |
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