The LIFT Home Study is an observational, single-arm study designed to assess the safety of non-invasive electrical spinal stimulation (ARC Therapy) administered by the LIFT System to treat upper extremity functional deficits in people with chronic tetraplegia.
The primary goal of this study is to report on the safety of the study device when used at home. In addition, the study will report on observed changes in upper extremity function and strength after a period of home use. The LIFT Home Study will enroll subjects who have recently completed participation in the Up-LIFT Study. The study includes a set of baseline assessments to be completed in the clinic, a four-week home use treatment program prescribed by the investigator, and a final set of clinic-based assessments at the end of the study. At the baseline visit, the subject and caregiver will be trained on the use of the device and prescribed a specific training regime for its use at home. The subject will be issued a device that is uniquely programmed to operate within a limited set of parameters as specified by the investigator. Throughout the study, subjects will be prompted to report all adverse events (AE) regardless of relatedness to the device. At baseline and the final clinic visit, UE strength and function will be measured with stimulation off using a comprehensive set of assessment tools including CUE-T, GRASSP, Pinch and Grasp Force, as well as patient and caregiver global impression of change questionnaires.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
The LIFT System delivers the Functional task practice and ARC Therapy to improve upper extremity function in individuals with tetraplegia.
Craig Hospital
Englewood, Colorado, United States
Shepherd Center- Crawford Research Institute
Atlanta, Georgia, United States
INSPIRE Laboratory, Spaulding Hospital
Cambridge, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Incidence of all adverse events (AEs)
Observational data regarding the incidence of all adverse events related to the use of the study device and treatment procedures will be reported.
Time frame: Through completion of the study, an average of 6 months
Extended use of the LIFT System at home
The secondary outcome measure will report on the potential for extended use of the LIFT System at home to sustain or advance performance gains achieved during the prior in-clinic treatment phase. Upper extremity performance will be assessed using the CUE-T, GRASSP, Pinch and Grasp Force assessments and the Global Impression of Change questionnaire.
Time frame: Through completion of the study, an average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Washington
Seattle, Washington, United States