Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- shoulder pain
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
shoulder pain
Time Frame: From baseline up to two weeks
Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)
shoulder strength
Time Frame: From baseline up to two weeks
Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms
Secondary Outcomes
No secondary outcomes reported