Statement of Work is as described below and in SA#4 and SA#5 of the grant proposal upon which the Prime Award is based. In this research partnership (between customKYnetics Inc. and Arizona State University), we propose to evaluate a prototype electrical stimulation system for adaptively controlled electrical stimulation to elicit a leg-press exercise movement in a population of individuals who have experienced a motor incomplete spinal cord injury (iSCI). The StimGym device essentially has four components: seat that moves along a single degree-of-freedom and allows the user to leg-press exercises; a visual display that provides movement targets and biofeedback of movement; a motor to assist or resist movement; and electrical stimulation system to activate paralyzed muscles. The overall purpose of the study is to determine the feasibility of customKYnetics StimGym stimulation system for use in this application/population. Specific Aim #4: Validation Study The validation at ASU will consist of two sets of experiments. The first set will use a sample of 3 able-bodied individuals. The purpose of the first study is the validation of the visual display and operation of the motorized portion of the StimGymv device. This study will use able-bodied subjects and does not use electrical stimulation. Results from this able-bodied study may lead to refinement of the device and protocols that will be used in a future study on individuals with incomplete spinal cord injury. The second set of experiments will use 1 individual with incomplete spinal cord injury who will participate in 3 experimental sessions. The outcome of this study will be validation of the electrical stimulation and of the mechanical designs intended to maintain safe orientation of the paralyzed lower extremities throughout the exercise. Specific Aim #5: Efficacy Study The ASU team will conduct a clinical efficacy study of the StimGym device. The study will assess outcomes related to exercise and neuromotor rehabilitation of the StimGym for individuals with chronic incomplete spinal cord injury. The protocol will involve 24 sessions (8 weeks; 3x per week) of therapy and evaluation on each of 10 subjects. Specifically, Collaborator agrees to complete the following objectives: Recruit and enroll 3 able-bodied subjects; Schedule each subject for 1 data collection session Recruit and enroll 1 subject with incomplete spinal cord injury for 3 data collection sessions for the validation study Recruit and enroll 10 subjects with incomplete spinal cord injury for 24 sessions for the evaluation study For each group of subjects: Perform data collection sessions as described in the methods of the approved grant proposal and per the IRB approved protocol and informed consent form. Assist with interpretation of data Maintain all research data that is collected at the ASU site Collaborator assures that all laboratory apparatus required to conduct the protocol will be available as needed in support of project work. Sponsor agrees to provide the investigational device as described in SA #1 and #2 of the attached grant proposal for use in the stated work and to support the device as needed during Collaborators conduct of stated work.
|Effective start/end date||8/1/12 → 3/31/13|
- HHS-NIH: National Institute of Child Health & Human Development (NICHD): $201,225.00