MedTrace Logo

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

NCT06828510 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-02-14

No results posted yet for this study

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

Interventions

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 :

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Thibaud LANSAMAN, MD · SMR DEPARTMENT, Raymon Pincaré Hospital - APHP

  • Samuel POUPLIN, PhD · PFNT DEPARTMENT, Raymon Pincaré Hospital - APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-06-30
Completion
2026-07-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06828510 on ClinicalTrials.gov