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Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability

Primary Purpose

Shoulder Instability

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Action observation therapy

About this trial

This is an interventional treatment trial for Shoulder Instability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects undergoing capsule-plastic surgery or Latarjet stabilization for shoulder instability

Exclusion Criteria:

Previous upper limb surgery
Cognitive impairments
Visual or auditory impairments
Postoperative complications limiting upper limb motor recovery (e.g., infections)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

AOT

Control

Arm Description

Outcomes

Primary Outcome Measures

Changes in shoulder function

Simple shoulder test

Changes in shoulder function

Disability Arm Shoulder Hand - DASH

Secondary Outcome Measures

Changes in shoulder pain

Numerical Pain Rating Scale (0 - best outcome, 100 worst outcome)

Changes in shoulder range of motion

Flexion, abduction, inernal and external rotation range of motion assessed using a goniometer

Changes in fear of movement

Tampa scale of kinesiophobia

Changes in quality of life

Short Form - 36 items

Full Information

NCT ID

NCT05479539

First Posted

July 27, 2022

Last Updated

July 27, 2022

Sponsor

Istituto Clinico Humanitas

1. Study Identification

Unique Protocol Identification Number

NCT05479539

Brief Title

Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability

Official Title

Effects of Action Observation Therapy in Patients Undergoing Surgery for Shoulder-instability

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 1, 2022 (Anticipated)

Primary Completion Date

May 1, 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Clinico Humanitas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The study will aim at investigating the effects of action observation therapy (action observation plus motor imagery) in patients with shoulder instability undergoing capsulo-plastic surgery. Forty subjects scheduled for capsulo-plastic surgery will be randomized into an AOT or Control group. AOT group will undergo action observation followed by motor imagery of upper limb motor tasks for 4 weeks after surgery, whereas Control group will perform no intervention. In addition, both groups will undergo postoperative usual care including immobilization with a brace and passive upper limb mobilization. All participants will be assessed for shoulder pain, function, range of motion, fear of movement and quality of life the day before surgery, at training end and 3 months after training end.

6. Conditions and Keywords

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

Shoulder Instability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

AOT

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Action observation therapy

Intervention Description

Participants will watch 12-minute video-clips followed by 8 minutes of motor imagery. Video-clips observation and imagination will be focused un shoulder tasks occuring on the three planes of motion.

Primary Outcome Measure Information:

Title

Changes in shoulder function

Description

Simple shoulder test

Time Frame

At baseline, after 4 weeks of training and at 3 month after the training end

Title

Changes in shoulder function

Description

Disability Arm Shoulder Hand - DASH

Time Frame

At baseline, after 4 weeks of training and at 3 month after the training end

Secondary Outcome Measure Information:

Title

Changes in shoulder pain

Description

Numerical Pain Rating Scale (0 - best outcome, 100 worst outcome)

Time Frame

At baseline, after 4 weeks of training and at 3 month after the training end

Title

Changes in shoulder range of motion

Description

Flexion, abduction, inernal and external rotation range of motion assessed using a goniometer

Time Frame

At baseline, after 4 weeks of training and at 3 month after the training end

Title

Changes in fear of movement

Description

Tampa scale of kinesiophobia

Time Frame

At baseline, after 4 weeks of training and at 3 month after the training end

Title

Changes in quality of life

Description

Short Form - 36 items

Time Frame

At baseline, after 4 weeks of training and at 3 month after the training end

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects undergoing capsule-plastic surgery or Latarjet stabilization for shoulder instability Exclusion Criteria: Previous upper limb surgery Cognitive impairments Visual or auditory impairments Postoperative complications limiting upper limb motor recovery (e.g., infections)

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability

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