Shoulder Pain Clinical Trial
Official title:
Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
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 |
Verified date | January 2022 |
Source | University of Padova |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Nutrition and Exercise Lab, DSB, University of Padova | Padova |
Lead Sponsor | Collaborator |
---|---|
University of Padova |
Italy,
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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