Arthrosis
Conditions
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.
Interventions
DEVICEAMADEO
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.
PROCEDUREStandard 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.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS functionality | Baseline, 1, 3 and 6 months after treatment | VAS scale |
| Dreiser index | Baseline, 1, 3 and 6 months after treatment | Dreiser index |
Countries
Italy
Outcome results
None listed