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

NCT06828510 | Not Yet Recruiting

• 2 other identifiers: APHP2410062024-A02447-40
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Disability Physical

Keywords

disability; robotic; impairment; upper limb

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 45

Study Arms (1)

ORTHOPUS PARTNER

EXPERIMENTAL

Device: With device

Interventions

With device 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 :

ORTHOPUS PARTNER

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• A relative must be available for the installation visit, and either the patient or the relative must have the necessary equipment to record videos in ecological conditions (smartphone or tablet).)

You may not qualify if:

• 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.
• Any conditions or injuries that may interfere with functional assessments.
• Patients under legal guardianship or curatorship.
• Lack of health insurance coverage.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Officials

• Thibaud LANSAMAN, MD

  SMR DEPARTMENT, Raymon Pincaré Hospital - APHP

  PRINCIPAL INVESTIGATOR

• Samuel POUPLIN, PhD

  PFNT DEPARTMENT, Raymon Pincaré Hospital - APHP

  STUDY DIRECTOR

Central Study Contacts

Thibaud LANSAMAN, MD

CONTACT

+ 33 (0)1 47 10 77 52; thibaud.lansaman@aphp.fr

Samuel POUPLIN, PhD

CONTACT

+ 33 (0)1.71.14.49.21; samuel.pouplin@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 14, 2025
• Study Start: March 1, 2025
• Primary Completion: June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 14, 2025

Record last verified: 2025-01