Digital Therapy in Shoulder Rehabilitation.

NCT ID: NCT05230056

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2021-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PG

Group Type EXPERIMENTAL

PG

Intervention Type BEHAVIORAL

Shoulder Digital therapy

CTRL

Group Type ACTIVE_COMPARATOR

CTRL

Intervention Type BEHAVIORAL

Shoulder non-digital therapy

Interventions

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PG

Shoulder Digital therapy

Intervention Type BEHAVIORAL

CTRL

Shoulder non-digital therapy

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Padova

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nutrition and Exercise Lab, DSB, University of Padova

Padua, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 37420268 (View on PubMed)

Other Identifiers

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PLYDT

Identifier Type: -

Identifier Source: org_study_id

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