Digital Therapy in Shoulder Rehabilitation.
Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2021
CompletedFirst Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 8, 2022
CompletedFebruary 8, 2022
January 1, 2022
6 months
January 27, 2022
January 27, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
shoulder pain
Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)
From baseline up to two weeks
shoulder strength
Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms
From baseline up to two weeks
Study Arms (2)
PG
EXPERIMENTALCTRL
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies
- pain between 2/10 and 8/10 on a visual analogue scale
You may not qualify if:
- post-surgical patients
- inability to perform active exercises
- peripheral neurological deficits
- cervical-brachialgia
- algodystrophy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nutrition and Exercise Lab, DSB, University of Padova
Padua, 35131, Italy
Related Publications (1)
Rizzato A, Pizzichemi M, Gobbi E, Gerardi A, Fortin C, Copcia A, Paoli A, Marcolin G. Effectiveness and therapeutic compliance of digital therapy in shoulder rehabilitation: a randomized controlled trial. J Neuroeng Rehabil. 2023 Jul 8;20(1):87. doi: 10.1186/s12984-023-01188-7.
PMID: 37420268DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 8, 2022
Study Start
January 1, 2021
Primary Completion
June 30, 2021
Study Completion
November 30, 2021
Last Updated
February 8, 2022
Record last verified: 2022-01
Data Sharing
- IPD Sharing
- Will not share