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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
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

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

    First Posted
    July 27, 2022
    Last Updated
    July 27, 2022
    Sponsor
    Istituto Clinico Humanitas
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    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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