Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Shoulder Instability
• Intervention / Treatment: Behavioral: Action observation therapy

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: AOT	Behavioral: Action observation therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in shoulder function	Simple shoulder test	At baseline, after 4 weeks of training and at 3 month after the training end
Changes in shoulder function	Disability Arm Shoulder Hand - DASH	At baseline, after 4 weeks of training and at 3 month after the training end

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in shoulder pain	Numerical Pain Rating Scale (0 - best outcome, 100 worst outcome)	At baseline, after 4 weeks of training and at 3 month after the training end
Changes in shoulder range of motion	Flexion, abduction, inernal and external rotation range of motion assessed using a goniometer	At baseline, after 4 weeks of training and at 3 month after the training end
Changes in fear of movement	Tampa scale of kinesiophobia	At baseline, after 4 weeks of training and at 3 month after the training end
Changes in quality of life	Short Form - 36 items	At baseline, after 4 weeks of training and at 3 month after the training end

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: July 27, 2022
• First Posted (Actual): July 29, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 27, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: CLF21/03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No