Shoulder PainNCT05230056
Digital Therapy in Shoulder Rehabilitation.
A study testing PG and CTRL in people with Shoulder Pain, run by University of Padova at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- PG and CTRL
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2021to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies
- pain between 2/10 and 8/10 on a visual analogue scale
Who cannot join
- post-surgical patients
- inability to perform active exercises
- peripheral neurological deficits
- cervical-brachialgia
- algodystrophy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
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.
- Conditions
- Shoulder Pain
- Being tested
- PG, CTRL
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PGBehavioural
Shoulder Digital therapy
CTRLBehavioural
Shoulder non-digital therapy
| Study group | Role | What they receive |
|---|---|---|
| PG | Experimental | Not described Receives: Behavioral: PG |
| CTRL | Active comparator | Not described Receives: Behavioral: CTRL |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder pain
Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)
Measured: From baseline up to two weeks
shoulder strength
Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms
Measured: From baseline up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230056
- Sponsor's protocol ID
- PLYDT
- Status last verified
- Jan 2022
- First submitted
- 27 Jan 2022
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37420268
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
- ClinicalTrials.gov ID
- NCT05230056
- Acronym / sponsor ID
- PLYDT
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 8 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PG | Experimental | Behavioral: PG |
| CTRL | Active comparator | Behavioral: CTRL |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- impingement syndrome, capsulitis, tendon injuries, degenerative joint or tendon pathologies
- pain between 2/10 and 8/10 on a visual analogue scale
Key exclusion criteria (5 listed)
- post-surgical patients
- inability to perform active exercises
- peripheral neurological deficits
- cervical-brachialgia
- algodystrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PGShoulder Digital therapy | Behavioural | PG |
| CTRLShoulder non-digital therapy | Behavioural | CTRL |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Derived from this study: PubMed 37420268Rizzato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PG and CTRL in people with Shoulder Pain, run by University of Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder pain (time frame: From baseline up to two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05230056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.