Digital Therapy in Shoulder Rehabilitation.

January 27, 2022 updated by: University of Padova

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PG
Behavioral: PG
Shoulder Digital therapy
Active Comparator: CTRL
Behavioral: CTRL
Shoulder non-digital therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
shoulder pain
Time Frame: From baseline up to two weeks
Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)
From baseline up to two weeks
shoulder strength
Time Frame: From baseline up to two weeks
Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms
From baseline up to two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Padova

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 8, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLYDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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