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

Not Applicable

Completed

• Conditions: Arthrosis
• Interventions: Procedure: Standard of care; Device: AMADEO

• Registration Number: NCT06633796
• Lead Sponsor: IRCCS Sacro Cuore Don Calabria di Negrar

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-25
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-15
• Study First Submitted: 2024-10-07
• Study First Submitted QC: 2024-10-07
• Study First Posted: 2024-10-09
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard care	Standard of care	Rehabilitation treatment with occupational therapy and paraffin therapy.
AMADEO	AMADEO	Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers.

Primary Outcome Measures

Name	Time	Method
VAS functionality	Baseline, 1, 3 and 6 months after treatment	VAS scale
Dreiser index	Baseline, 1, 3 and 6 months after treatment	Dreiser index

Trial Locations

Locations (1)

IRCCS Sacro Cuore Don Calabria di Negrar; 🇮🇹 Negrar, Verona, Italy