Clinical Feasibility of the IMES Transradial Prosthesis
ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorÖssur Iceland ehf
About this trial
This study will evaluate the feasibility of using implanted myoelectric sensors (IMES) to control a transradial prosthesis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(unilateral acquired transradial) amputation
residual limb size requirements to fit investigational device componentry
at least 6 residual muscle locations available for implantation
good compliance with health service (rehabilitation)
Disqualifiers
any condition which in the opinion of the investigator poses a risk to health
neurological disorder that may prohibit accurate control
major injury proximal to the level of amputation
neuromuscular disorder
Trial design
Design model
Single group
Treatments tested in this trial
IMES
DeviceSurgical implantation of IMES
Treatment groups
3 Participants
are divided into 1 treatment groupGroup A: Single armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Grip Accuracy
Self-drafted assessment of accuracy in prosthesis movements. The purpose of this measure is to quantify subjects' ability to use the investigational device to control specific prosthetic movements. When performing the Accuracy Test, the subject attempts to execute a series of specified wrist and hand movements using the investigational device. An objective rater scores each movement on a 0-3 scale with 0 = no movement observed and and 3 = movement observed (with no unintended movements). A score is given for each movement and a combined score is derived from the complete set of movements. Administered as a repeated measure, the Grip Accuracy test assesses Change over time (training effect).
Time frame
The measure will be carried out 11 times during the study, at Baseline with the subject's own device for comparison, and at 10 study visits with the investigational device conducted over approximately 6 months.Sponsors and contacts
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Source ClinicalTrials.gov