NCT06633796

Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated with Robotics in Patients with Erosive Osteoarthritis

Pilot Experimental Study: Efficacy of Paraffin Therapy and Occupational Therapy Associated

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar · Academic / Other
• Sex: All
• Age: 35 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, evaluator-blinded, non-profit, single-center, exploratory, medical device clinical trial aimed at evaluating the efficacy in terms of reduction of functional limitation of the combination of occupational therapy, paraffin therapy, and robotic arm mobilization compared to the center's SoC, i.e. paraffin therapy and occupational therapy.

Conditions

• Arthrosis

Interventions

Type	Name	Description
DEVICE	AMADEO	304 / 5.000 The rehabilitation treatment includes 10 sessions of combined treatment of paraffin therapy, functional occupational therapy and polyarticular mobilization of the fingers with a robotic arm (Amadeo). The sessions will be scheduled 2 times a week for 5 consecutive weeks.
PROCEDURE	Standard of care	The rehabilitation treatment includes 10 sessions of combined treatment of paraffin therapy and occupational therapy for functional purposes. The sessions will be scheduled 2 times a week for 5 consecutive weeks.

Timeline

• Start date: 2021-01-25
• Primary completion: 2024-02-15
• Completion: 2024-02-15
• First posted: 2024-10-09
• Last updated: 2024-12-02

Locations

1 site across 1 country: Italy