Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability

Shoulder Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05479539
• Other study ID #: CLF21/03
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2022
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Joint Instability
• Shoulder Instability

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in shoulder function	Simple shoulder test	At baseline, after 4 weeks of training and at 3 month after the training end
Primary	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	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
Secondary	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
Secondary	Changes in fear of movement	Tampa scale of kinesiophobia	At baseline, after 4 weeks of training and at 3 month after the training end
Secondary	Changes in quality of life	Short Form - 36 items	At baseline, after 4 weeks of training and at 3 month after the training end