Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability

NCT05479539 | Unknown

• 1 other identifier: CLF21/03
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Instability

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Changes in shoulder pain

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

• Changes in shoulder range of motion

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

• Changes in fear of movement

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

• Changes in quality of life

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

Study Arms (2)

AOT

EXPERIMENTAL

Behavioral: Action observation therapy

Control

NO INTERVENTION

Interventions

Action observation therapy BEHAVIORAL

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.

AOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: July 29, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share