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Clinical Trials

Assisted Upper Limb Movement for Assessment and Therapy (PI: H.F. Machiel Van der Loos, PhD). Applied Resources, Corp. Clinical trials with 4 hemiplegic chronic stroke subjects to evaluate the ARC-MIME prototype.

Clinical Trial of Artificial Peripheral Nerve Graft (Co-PI: Eric E. Sabelman, PhD and V. Rodney Hentz, MD). VA Merit Review. Evaluation of all upper limb nerve surgery cases during 18-month recruitment window resulted in 3 candidates for artificial nerve graft. Project ended with no subjects enrolled to date.

Coordination of Hemiparetic Movement after Post-Stroke Rehabilitation (PI: Steven A. Kautz, PhD and Duncan). VA Merit Review. Trials with 6 persons enrolled to date at Kansas University Center on Aging. The study will include 60-70 patients enrolled in a larger, NIH funded randomized clinical trial (PI: Duncan) to evaluate a post-stroke exercise program designed to increase balance, strength and endurance.

Development of an Assistive Robot for Effective Health Care Delivery (Co-PI: H.F. Machiel Van der Loos, PhD and Charles G. Burgar, MD). VA Merit Review. Trials with 4 persons with high-level quadriplegia to evaluate ProVAR's novel interface.

Differential Pressure Walking Assistance (Co-PI: Charles G. Burgar, MD and Robert T. Whalen, PhD). VA Merit Review. Thirty-one subjects participated in an evaluation of a method that uses air pressure to provide partial body weight support during ambulation.

Functional Restoration of Grasp in Quadriplegia (Co-PI: V. Rodney Hentz, MD and Felix E. Zajac, PhD). VA Merit Review. Developed a computer model of the musculotendinoskeletal system of the nonparetic index finger and thumb to better understand muscle coordination and biomechanics in the generation of key and tip pinch forces. This model has been used to modify a common tendon transfer procedure (Zancolli lasso), leading to improved hand function in tetraplegic patients.

Graded Weight-bearing Exercise for Improving Ambulation after Stroke (Co-PI: David A. Brown, PhD PT and Charles G. Burgar, MD) VA Merit Review. Compared pedaling on the TiltCycle to strength training as an adjunct to gait training. Twenty-six subjects with chronic hemiplegia were tested.

Improving Stepping Over Responses in the Elderly Using Simulated Objects (PI: David L. Jaffe, MS). VA Merit Review. Trials with 9 persons enrolled to date. The purpose of these trials is to construct and test a system for individuals with stroke that: 1) employs techniques to monitor and improve their stepping-over response time; and 2) trains them in more effective movement strategies.

Mechanically-assisted Upper Limb Movement for Assessment and Therapy (Co-PI: Charles G. Burgar, MD and H.F. Machiel Van der Loos, PhD). VA Merit Review. Clinical trial of robot-assisted stroke therapy using MIME. Twenty-eight subjects with chronic hemiplegia received conventional or robot-assisted therapy.

Reliability and Validity of Accelerometric Gait and Balance Diagnosis (Co-PI: Eric E. Sabelman, PhD and Winograd). VA Merit Review. Test-retest trials of 10 young (18-35 years) and 85 healthy elderly (60-90 years) to establish reliability of wearable accelerometric motion analysis system. Test protocol was applied to 37 healthy elderly subjects before and after 4-month double-blind study of Gingko biloba (with Stanford Center for Research in Disease Prevention) and clinical diagnosis of 2 veterans with idiopathic peripheral neuropathy.

Robot-assisted Upper Limb Neuro-Rehabilitation (Co-PI: Charles G. Burgar, MD and Peter S. Lum, PhD) VA Merit Review. Clinical trial of robot-assisted therapy using MIME in patients 1-2 months post-stroke. Conventional therapy is being compared to 3 robot-assisted techniques.