The study is a prospective, multicenter, interventional, open clinical trial, in Single Case Experimental Design (SCED) in multiple introduction withdrawal, controlled, randomized.
Have a loss of mobility in the upper limb (UL).
Have minimal functional capacities in the upper limb, defined by a score between 1 and 4 on the Lovett scale for all muscle groups of the arm, except for the hand and wrist.
Demonstrate effective distal motor skills in the upper limb to be fitted.
Be an informed patient who has provided signed consent, or in the case of minors, have given assent along with the signed consent of legal guardians.
Patients with cognitive or behavioral dysfunctions that may compromise adherence to instructions and procedures required for the trial (at the discretion of the investigator clinician).
Patients already enrolled in an interventional clinical trial.
History of fractures in the upper limb to be fitted within the six months preceding the inclusion visit in the trial.
Any conditions or injuries that may interfere with functional assessments.
Single group
With device
DeviceMedical Device Installation Visit (V2, Day 0 + 21 ± 10 days): This visit, lasting approximately 1.5 hours, takes place in a consultation room at the center. A representative from ORTHOPUS adapts and installs the Partner on the patient's wheelchair, and an initial training session on the use of the medical device is provided. Use of the Medical Device in Ecological Conditions (between V2 and V3): Between Day 21 and Day 42, the patient is invited to use the MD without restrictions in real-life conditions. Final Evaluation Visit (V3, three weeks after V2, up to four weeks if necessary): The assessment session for the primary outcome-functional goal achievement using the GAS method-is conducted following the SCED (Single-Case Experimental Design) procedure, with multiple introduction-withdrawal phases and randomized phase sequencing and repeated measures :
Personalized functional goal achievement score
Personalized functional goal achievement score, defined using the Goal Attainment Scaling (GAS) method, assessed after three weeks of Partner use, both with and without the Partner. The Goal Attainment Scale (GAS) is an individualized outcome measure involving goal selection and goal scaling that is standardized in order to calculated the extent to which a patient's goals are met.
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This trial is not recruiting at the moment. You can still explore other options:
