๐ฌIn plain words
What the trial is, and whether it could suit you
The purpose of this study is to evaluate functional mobility, control, and user satisfaction from persons who have an amputation above the knee and have received osseo-integration (OI) and targeted muscle reinnervation (TMR) surgery, while walking with a powered knee and ankle prosthesis.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Unilateral lower limb amputation at the transfemoral level
* Existing prosthesis wearer
* K2/K3/K4 level ambulation
* 18-70 years old
* Mini-Mental State Exam (MMSE) score greater than 17
* Ability to demonstrate proper safety with passive prosthesis
* Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes
* Candidate for OI surgery as verified by surgical team or has previously received OI
* Candidate for TMR surgery as verified by surgical team or has previously received TMR
Exclusion Criteria:
* Unable to successfully receive osseointegration and TMR
* Significant new injury that would prevent use of a prosthesis: Ability to consistently wear prosthesis and perform activities of daily living and specific performance tasks is necessary to properly evaluate the relative benefits of the intervention
* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data.
* Visually impaired
* Proximal nerve injury that prevents TMR
* Individuals who smoke: may interfere with OI process from both bone healing and soft tissue standpoints
* Individuals with active implants.
* Significant comorbidity that would preclude completion of the study, use of prostheses, or would otherwise prevent data acquisition by researchers