Shoulder InstabilityNCT05479539
Action Observation Therapy in Patients Undetgoing Surgery for Shoulder Instability
A study testing Action observation therapy in people with Shoulder Instability, run by Istituto Clinico Humanitas.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Instability
- What is being tested?
- Action observation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing capsule-plastic surgery or Latarjet stabilization for shoulder instability
Who cannot join
- Previous upper limb surgery
- Cognitive impairments
- Visual or auditory impairments
- Postoperative complications limiting upper limb motor recovery (e.g., infections)
About this study
Official title: 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.
- Conditions
- Shoulder Instability
- Being tested
- Action observation therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Action observation therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AOT | Experimental | Not described Receives: Behavioral: Action observation therapy |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in shoulder function
Simple shoulder test
Measured: At baseline, after 4 weeks of training and at 3 month after the training end
Changes in shoulder function
Disability Arm Shoulder Hand - DASH
Measured: At baseline, after 4 weeks of training and at 3 month after the training end
Secondary outcomes (4)
Changes in shoulder pain
Numerical Pain Rating Scale (0 - best outcome, 100 worst outcome)
Measured: 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
Measured: At baseline, after 4 weeks of training and at 3 month after the training end
Changes in fear of movement
Tampa scale of kinesiophobia
Measured: At baseline, after 4 weeks of training and at 3 month after the training end
Changes in quality of life
Short Form - 36 items
Measured: At baseline, after 4 weeks of training and at 3 month after the training end
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479539
- Sponsor's protocol ID
- CLF21/03
- Status last verified
- Jul 2022
- First submitted
- 27 Jul 2022
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Action Observation Therapy in Patients Undergoing Surgery for Shoulder-instability
- ClinicalTrials.gov ID
- NCT05479539
- Acronym / sponsor ID
- CLF21/03
- Conditions
- Shoulder Instability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AOT | Experimental | Behavioral: Action observation therapy |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects undergoing capsule-plastic surgery or Latarjet stabilization for shoulder instability
Key exclusion criteria (4 listed)
- Previous upper limb surgery
- Cognitive impairments
- Visual or auditory impairments
- Postoperative complications limiting upper limb motor recovery (e.g., infections)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Action observation therapyParticipants 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. | Behavioural | AOT |
Primary outcome
Changes in shoulder function
Time frame: At baseline, after 4 weeks of training and at 3 month after the training end
Simple shoulder test
Changes in shoulder function
Time frame: At baseline, after 4 weeks of training and at 3 month after the training end
Disability Arm Shoulder Hand - DASH
4 secondary outcomes
Changes in shoulder pain
Time frame: At baseline, after 4 weeks of training and at 3 month after the training end
Changes in shoulder range of motion
Time frame: At baseline, after 4 weeks of training and at 3 month after the training end
Changes in fear of movement
Time frame: At baseline, after 4 weeks of training and at 3 month after the training end
Changes in quality of life
Time frame: At baseline, after 4 weeks of training and at 3 month after the training end
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Action observation therapy in people with Shoulder Instability, run by Istituto Clinico Humanitas.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in shoulder function (time frame: At baseline, after 4 weeks of training and at 3 month after the training end). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.