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Digital Therapy in Shoulder Rehabilitation.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05230056
Recruitment Status : Completed
First Posted : February 8, 2022
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
University of Padova

Study Description
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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.


Condition or disease Intervention/treatment Phase
Shoulder Pain Behavioral: PG Behavioral: CTRL Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arms and Interventions
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Arm Intervention/treatment
Experimental: PG Behavioral: PG
Shoulder Digital therapy
Active Comparator: CTRL Behavioral: CTRL
Shoulder non-digital therapy


Outcome Measures
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Primary Outcome Measures :
  1. shoulder pain [ Time Frame: From baseline up to two weeks ]
    Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)

  2. shoulder strength [ Time Frame: From baseline up to two weeks ]
    Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05230056


Locations
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Italy
Nutrition and Exercise Lab, DSB, University of Padova
Padova, Italy, 35131
Sponsors and Collaborators
University of Padova
More Information
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Responsible Party: University of Padova
ClinicalTrials.gov Identifier: NCT05230056    
Other Study ID Numbers: PLYDT
First Posted: February 8, 2022    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
 Musculoskeletal Diseases
Pain
Neurologic Manifestations