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OpenTrials
Completed

NCT Number: NCT05230056

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nutrition and Exercise Lab, DSB, University of Padova

Padova, 35131, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PG

Behavioral

Shoulder Digital therapy

CTRL

Behavioral

Shoulder non-digital therapy

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Padova

Other

Registry information

Official study title

Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 8, 2022
Registry last updated
Feb 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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