Clinical trial NCT04043234: RESCU System for Robust Upper Limb Prosthesis Control
Official title: User-driven Retrospectively Supervised Classification Updating (RESCU) System for Robust Upper Limb Prosthesis Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Amputation
Upper Limb
Keywords: upper limb
amputation
prosthesis
myoelectric
pattern recognition
Lead sponsor: Infinite Biomedical Technologies
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Case Experimental Design (SCED)
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will compare the use of RESCU \[Experimental\] Prosthesis with a \[Standard\] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.

Detailed description: The AB sequence for the study protocol is described below, where control type A is the Standard prosthesis and control type B is the Experimental prosthesis.

On Day 0, the participant will be evaluated with the Standard prosthesis. A series of Measures (as defined in the next paragraph) will then be recorded. The participant will then take the prosthesis home for one week, and daily use data will be recorded. The participant will return to the clinic for Day 7 Measures and download of the daily use data. During this session, the participant will be fit with the second system, undergo occupational therapy in the clinic, and Measures will be recorded. There will be no washout period as the prosthesis is expected to be in daily use. The participants will go home for a four-week period and return on Day 35 for a third set of Measures. At this time, the participant will be asked which prosthesis he/she prefers.

There are limited functional outcome assessment options for the planned comparison. However, the investigators will test functional measures at the clinic appointments, examine daily use data, and administer several qualitative surveys to assess participant outcomes.

Eligibility criteria: Inclusion Criteria:

* Trans-radial limb difference.
* Candidate for a 2+ degree-of-freedom (DoF) myoelectric pattern recognition prosthesis as determined by the study prosthetist
* Active pattern recognition myoelectric prosthesis user
* Fluent in English
* Age of 18 years or greater

Exclusion Criteria:

* Patients with a residual limb that is unhealed from the amputation surgery
* Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes
* Unhealed wounds
* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
* Serious uncontrolled medical problems as judged by the project therapist

Primary outcomes:
measure: Mean Daily Prosthesis Use Duration
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Activities Measure for Upper Limb Amputees (AM-ULA)
timeFrame: Baseline, Post-Fitting, Post-Intervention
measure: Orthotics and Prosthetics User's Survey Upper Extremity Functional Status (OPUS UEFS)
timeFrame: Baseline, Post-Intervention
measure: Trinity Amputation and Prosthesis Experience Survey for Upper Limb Amputation (TAPES-ULA)
timeFrame: Baseline, Post-Intervention
measure: PROMIS Satisfaction Short Form 8a
timeFrame: Baseline, Post-Intervention
measure: Pain Scale
timeFrame: Baseline, Post-Fitting, Post-Intervention
measure: Socket Comfort Score
timeFrame: Baseline, Post-Fitting, Post-Intervention
measure: Range of Motion (of Residual Joints)
timeFrame: Baseline, Post-Fitting
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: Medical Center O&P
state: Maryland
Study officials:
References: