ClinicalTrials.gov identifier: NCT01901081
Purpose: This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control an electromechanical prosthetic wrist and hand.
Study type: Interventional
Study design: Safety/efficacy study, single group assessment, open label
Estimated enrollment: 10
Eligibility criteria: Both genders are eligible; ages 18 years and older. Patients must be health care beneficiaries at Walter Reed National Military Medical Center; must have transradial amputation with one-third or greater residual forearm length as determined by the contralateral side and residual forearm anatomy that supports the implantation and control of at least six implanted myoelectric sensors (to be verified during a study-specific screening test); must be able to speak and comprehend English; must provide informed consent; must have undergone amputee rehabilitation, including being trained to wear and use a body-powered and myoelectric prosthesis; must report wearing an upper limb prosthesis for at least 2 hours per day; must have a unilateral amputation with preserved function in the non-amputated arm; must be willing and capable of having electromyography needles inserted into the forearm and be cognitively capable of operating an implanted myoelectric sensor prosthesis; must be willing to comply with a wearing schedule for the investigational device, and be willing and capable of travelling to the investigational site for study visits.
Study start date: May 2013
Estimated study completion date: May 2016
Estimated primary completion date: The final collection date for primary outcome measures will be May 2016.
Primary outcome measures: Device-related serious adverse events during the course of 2 years following implant; change in accuracy test score in tests conducted nine times during 2-year time period, requiring subjects to execute a series of different hand movements using the IMES to control an electromechanical wrist and hand
Secondary outcome measures: Change in Southampton Hand Assessment Procedure test score, conducted nine times after implantation during 2-year time period; change in assessment of capacity of myoelectric control test score, nine times during 2-year time period; change in box and block test score, conducted nine times during 2-year period; response to IMES Satisfaction Questionnaire, to be completed after 6 months of training
Sponsors and collaborators: Sponsored by The Alfred E. Mann Foundation for Scientific Research
Contact: Melissa L. Evangelista, MS; 661-702-6700 ext. 6743, melissa@aemf.org; Valma Klein, 661-702-6700 ext. 6833, valmak@aemf.org
Information acquired from: The Alfred E. Mann Foundation for Scientific Research, via clinicaltrials.gov
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