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NCT05230056 Clinical Trial

Digital Therapy in Shoulder Rehabilitation.

Shoulder Pain Clinical Trial

Official title:
Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05230056
Other study ID # PLYDT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2021
Est. completion date November 30, 2021

Study information
Verified date January 2022
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Digital therapy may provides real time visual feedbacks. Instrumented devices objectively quantify the patient's performance during rehabilitation and thus could be helpful for the personalization of the exercises. The interactive ball of this trial allows measuring both movement and pressure applied on it. Therefore, the objectives of this study are: (i) to evaluate whether the use of a novel digital therapy gaming system was therapeutically relevant during shoulder rehabilitation; (ii) to understand whether the device was effective in improving patients' engagement in comparison to a control non-gaming rehabilitation program.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date November 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility Inclusion Criteria: - impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies - pain between 2/10 and 8/10 on a visual analogue scale Exclusion Criteria: - post-surgical patients - inability to perform active exercises - peripheral neurological deficits - cervical-brachialgia - algodystrophy

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• PG
Shoulder Digital therapy
• CTRL
Shoulder non-digital therapy

Locations
Country Name City State
Italy Nutrition and Exercise Lab, DSB, University of Padova Padova

Sponsors (1)
Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary shoulder pain Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10) From baseline up to two weeks
Primary shoulder strength Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms From baseline up to two weeks
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