NCT06828510

Evaluation of ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

Evaluation of the ORTHOPUS Partner Arm in People With Disabilities Needing for Robotic Assistance to Compensate for Upper Limb Deficiency

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

The study is a prospective, multicenter, interventional, open clinical trial, in Single Case Experimental Design (SCED) in multiple introduction withdrawal, controlled, randomized.

Detailed description

The function of the upper limb associated with gripping is essential for carrying out activities of daily living (ADL): personal care, productive activities, leisure, etc. The upper limbs therefore have not only a functional dimension (bringing together, moving away, holding, taking, bringing to the mouth, scratching, etc.) but also a social and anthropological one. As such, a limitation of functionality of the upper limb will have a very significant impact on the quality of life, independence, autonomy and participation of the subjects. When the impairment of a function is irreversible, rehabilitation care may involve the use of aids that either optimize or replace the function. Thus, the orthoses or devices used can either assist the movement if a minimum of muscular strength and control is still present, or completely replace the function if the functional deficit is complete. Using the proprietary robotic actuator, ORTHOPUS has developed the Partner for people with disabilities, with residual strength in the arm. This device is therefore intended for people with a loss of function in the upper limbs. It supports the mobility of the arm by anti-gravity compensation and must help to regain autonomy during ADLs. The Partner is CE marked and classified as a class 1 MD. The hypothesis of the Clinical Investigation is that the Partner medical device is effective in improving the functional capacities of the equipped upper limb (LM), in patients, children and adults, eligible for a robotic compensation Upper Limb Technical Aid, after a period of use of said technical aid in ecological conditions.

Conditions

• Disability Physical

Interventions

Type	Name	Description
DEVICE	With device	Medical 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 :

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-02-14
• Last updated: 2025-02-14