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

NCT ID: NCT06633796

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-25

Study Completion Date

2024-02-15

Brief Summary

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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

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Conditions

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Arthrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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AMADEO

Rehabilitation treatment with occupational therapy, paraffin therapy and mobilization with robotic arm (AMADEO) of the fingers.

Group Type EXPERIMENTAL

AMADEO

Intervention Type DEVICE

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.

Standard care

Rehabilitation treatment with occupational therapy and paraffin therapy.

Group Type OTHER

Standard of care

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged between 35 and 70 years.
* Diagnosis of erosive osteoarthritis of the fingers confirmed clinically and radiologically.
* Presence of persistent functional limitation (at least 6 months) in finger flexion
* VAS value pain referred only to the hands \> 5 in the week prior to enrollment in the study.
* Patients not responding to anti-inflammatory and steroid therapy used in the last 2 years.
* Patients eligible for occupational therapy and paraffin therapy.
* Signature of the Informed Consent Form for participation in the study and processing of personal data.

Exclusion Criteria

* Patients aged \< 35 years and \> 70 years.
* Patients with diagnosis of overlapping arthritic pathologies.
* Patients undergoing hand surgery in the 6 months prior to the evaluation.
* Patients with functional alterations to the hands due to trauma.
* Patients with cognitive or mental disorders.
* Corticosteroid use within 6 months prior to baseline.
* Patients unable to use robots with mechanical arms
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Sacro Cuore Don Calabria di Negrar

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Sacro Cuore Don Calabria di Negrar

Negrar, Verona, Italy

Site Status

Countries

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Italy

Other Identifiers

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2020-60

Identifier Type: -

Identifier Source: org_study_id