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CompletedNCT05230056Updated Feb 8, 2022

Digital Therapy in Shoulder Rehabilitation.

An interventional study of PG and CTRL in Shoulder Pain, sponsored by University of Padova. Completed at 1 site in Italy. Open to participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by University of Padova · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Jan 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Shoulder Pain

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03

In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 22 is below the median of 60 across 561 interventional studies indexed under Shoulder Pain.

Browse Shoulder Pain studies →

Lead sponsor

University of Padova is the lead sponsor of 210 studies on the registry; 42 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
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

Exclusion Criteria:

  • post-surgical patients
  • inability to perform active exercises
  • peripheral neurological deficits
  • cervical-brachialgia
  • algodystrophy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    PG

    Behavioral: PG

  • Active comparator
    CTRL

    Behavioral: CTRL

Interventions

  • BehavioralPG

    Shoulder Digital therapy

  • BehavioralCTRL

    Shoulder non-digital therapy

06

What researchers measure

Primary outcomes

  1. shoulder pain

    Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)

    Time frame: From baseline up to two weeks

  2. shoulder strength

    Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms

    Time frame: From baseline up to two weeks

07

Study locations

1 site
  • Nutrition and Exercise Lab, DSB, University of Padova
    Padova, 35131, Italy
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05230056
Lead sponsor
University of Padova
Responsible party
Sponsor
First posted
Feb 8, 2022
Start date
Jan 1, 2021
Primary completion
Jun 30, 2021
Completion
Nov 30, 2021
Last update
Feb 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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