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Digital Therapy in Shoulder Rehabilitation.

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PG
CTRL
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nutrition and Exercise Lab, DSB, University of Padova

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PG

CTRL

Arm Description

Outcomes

Primary Outcome Measures

shoulder pain
Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)
shoulder strength
Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms

Secondary Outcome Measures

Full Information

First Posted
January 27, 2022
Last Updated
January 27, 2022
Sponsor
University of Padova
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1. Study Identification

Unique Protocol Identification Number
NCT05230056
Brief Title
Digital Therapy in Shoulder Rehabilitation.
Official Title
Effectiveness and Therapeutic Compliance of Digital Therapy in Shoulder Rehabilitation.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Padova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PG
Arm Type
Experimental
Arm Title
CTRL
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
PG
Intervention Description
Shoulder Digital therapy
Intervention Type
Behavioral
Intervention Name(s)
CTRL
Intervention Description
Shoulder non-digital therapy
Primary Outcome Measure Information:
Title
shoulder pain
Description
Shoulder pain by means of Visual Analogue Scale (no pain:0; maximal pain: 10)
Time Frame
From baseline up to two weeks
Title
shoulder strength
Description
Shoulder strength by means of an isometric maximal voluntary contraction measured in kilograms
Time Frame
From baseline up to two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Nutrition and Exercise Lab, DSB, University of Padova
City
Padova
ZIP/Postal Code
35131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Therapy in Shoulder Rehabilitation.

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