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
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Instability
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)
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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
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
No
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
No
Learn more about this trial
Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability
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