Shoulder Instability Subluxation BilateralASISTNCT06033157
Physiotherapist Supervised Training in Patients With Anterior Shoulder Instability
A study testing Physiotherapist supervised training in people with Shoulder Instability Subluxation Bilateral, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate if physiotherapist supervised training improves neuromuscular control in patients suffering from traumatic anterior shoulder instability. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Shoulder Instability Subluxation Bilateral
- What is being tested?
- Physiotherapist supervised training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Nov 2023to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-40 years.
- Unilateral traumatic anterior shoulder instability.
- Willingness to adhere to the study protocol, herein attend follow-up.
- Ability to speak, read, and understand Danish.
- Ability to give written informed consent.
Who cannot join
- Instability in the opposite shoulder.
- Off-track lesion.
- For both shoulders: Former or planned surgery.
- For both shoulders: posterior, multi-directional or atraumatic instability.
- For both shoulders: traumatic rotator cuff or biceps tendon tear.
- For both shoulders: traumatic fracture of proximal humerus (other than Hill-Sachs lesion), clavicula, scapula (other than glenoid) or dislocation of sternoclavicular or acromioclavicular joints.
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- For both shoulders: atraumatic shoulder pathologies (e.g. frozen shoulder, symptomatic osteoarthritis of the shoulder or acromioclavicular joints, acute tendinitis calcarean).
- Pregnancy.
- Terminal illness or severe medical illness: ASA score ≥3.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Sports Orthopedic Research Center - Copenhagen (SORC-C), Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre
Hvidovre, Capital Region, 2650
About this study
Official title: The Effect of Physiotherapist Supervised Training on Neuromuscular Control in Patients With Traumatic Anterior Shoulder Instability
The goal of this clinical trial is to investigate if physiotherapist supervised training improves neuromuscular control in patients suffering from traumatic anterior shoulder instability. The main question(s) it aims to answer are:
- Does physiotherapist supervised training improve shoulder neuromuscular control
- Does physiotherapist supervised training prevent recurring shoulder dislocations
- Is physiotherapist supervised training as good as surgery in improving shoulder neuromuscular control Participants will be randomised to either a training group or a no-training group.
Read more
Participants in the training group will undergo a 12 week training-program supervised by a physiotherapist.
Participants in the no-training group will receive a consultation with a shoulder surgeon, where information and general advice regarding the shoulder injury is provided.
Researchers will compare the training group to the no-training group to see if physiotherapist supervised training improves shoulder neuromuscular control in patients with traumatic anterior shoulder instability. The training group will also be compared to a historic group of patients with traumatic anterior shoulder instability, who underwent arthroscopic surgery.
Read the detailed description
- Aim: To investigate the effect of physiotherapist supervised training on shoulder neuromuscular control, and increase understanding of traumatic anterior shoulder instability.
- Main research questions:
A: Is supervised training in patients with traumatic anterior shoulder instability better in improving neuromuscular control, strength, apprehension and patient reported outcomes when compared to no training.
B: Is supervised training in patients with traumatic anterior shoulder instability better in preventing re-dislocations and need for surgical stabilisation when compared to no training.
C: Is supervised training in patients with traumatic anterior shoulder as good as Bankart surgery in improving neuromuscular control and patient reported outcome when compared to no training.
- Objectives for research question A:
To investigate if, in patients with traumatic anterior shoulder instability, a supervised 12-week training programme is better than no training in improving:
- Neuromuscular control
- Shoulder internal rotational strength
- Shoulder apprehension
- Patient reported outcomes
- Clinical shoulder instability Outcomes are measured at a) the end of the 12-weeks intervention and b) 6 months after the beginning of the intervention. Furthermore, patient reported outcomes is also measured at 1 and 2 years after the beginning of the intervention.
- Objective for research question B:
To investigate if, in traumatic anterior shoulder instability, a supervised 12-week training programme is better than no training in preventing a) re-dislocations and b) need for surgical stabilisation within the first 24 months.
- Objectives for research question C:
To investigate if, in patients with traumatic anterior shoulder instability, a specialised 12-week training programme is as good as arthroscopic Bankart surgery in improving:
- Neuromuscular control
- Shoulder internal rotational strength
- Shoulder apprehension
- Patient reported outcomes The training group is measured 6 months after the beginning of the intervention and the historic Bankart surgery group is measured 6 months after the surgery.
For all objectives neuromuscular control is investigated by determining a) shoulder joint position sense (JPS), b) shoulder reaction time, and c) shoulder sway length.
- Type of study: Pilot randomized controlled trial including 64 patients, which is allocated to either training og no-training (32 patients in each group).
- Time schedule: Recruitment and inclusion is planned to begin September 1st 2023 and is expected to last for 12-18 months. With a 2-year follow-up the complete study period is expected to last 3-3,5 years.
- Set-up: Patients presenting with shoulder instability in the outpatient clinic at Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, will be recruited for the study. Patients who have signed an informed consent form will be randomised to either training- og no training-intervention and undergo examinations prior to, as well as three and six months after beginning of the intervention. All examinations will take place at the Copenhagen University Hospital Hvidovre. Patients in the training-group will be refered to training supervised by a physiotherapist. The training will take place at either Copenhagen University Hospital Hvidovre or a municipal rehabilitation center in Copenhagen. All examinations will include neuromuscular testing, accompanied by a clinical shoulder examination, strength measures and a validated electronic questionnaires regarding shoulder-related function. A pre-interventional 3D computed tomography scan will be performed to evaluate bone loss.
- Being tested
- Physiotherapist supervised training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapist supervised trainingBehavioural
A 12 week physiotherapist supervised training program. The patient will receive supervision by a physiotherapist 6 times during the intervention period.
The patient is strongly encouraged to do the assigned training protocol at home 3 times a week. The supervised physiotherapy consists of introduction, review and progression of the assigned exercises. In addition, the patient will receive education and guidance in daily use of the arm and appropriate load on the shoulder.
| Study group | Role | What they receive |
|---|---|---|
| Training | Active comparator | A 12 week physiotherapist supervised training program Receives: Behavioral: Physiotherapist supervised training |
| No-training | No intervention | A short consultation with a designated orthopedic surgeon and a folder with general advice on how to avoid further dislocations and to relieve pain from the shoulder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular control - Shouldersway
- Shoulder sway. Measured as sway-length (in millimeter).
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Secondary outcomes (8)
Clinical examination - Shoulder instability
- Shoulder instability tests: Sulcus sign, load and shift, apprehension test, relocation test.
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Clinical examination - Shoulder range of motion
- Shoulder range of motion in flexion, extension, abduction, internal and external rotation
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Strength measure
Shoulder internal rotational strength, measured in Newton.
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Apprehension measure
An assessment (in degree) of when during an external rotational movement, the patient feels apprehension.
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Patient-reported outcome measures
- WOSI-score
- Purpose-made questions about return to sport and work, and fear of reinjury.
Measured: Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention
Redislocations
Patients will be asked on every visit, if they have sustained re-dislocation of their shoulder
Measured: Will be tested 3, 6, 12 and 24 months after the beginning of the intervention
Neuromuscular control - Joint Position Sense
- Joint position sense for shoulder external rotation. Repositioning error is measured in degree.
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Neuromuscular control - Reaction Time
- Reaction time. Measured as the time (in milliseconds) it takes the patient to respond to a sudden movement in the shoulder joint.
Measured: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Nov 2023
- Primary completionOct 2025 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Instability Subluxation BilateralStudies of the same condition, open and under way.
- 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
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Rask Andreasen, Hvidovre University Hospital
- Investigators
- Kristine R Andreasen, MD, Principal investigator, Copenhagen University Hospital, HvidovreKristoffer W Barfod, MD, PhD, Study chair, Copenhagen University Hospital, HvidovreKristoffer W Barfod, MD, PhD, Study director, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033157
- Sponsor's protocol ID
- ASIST-1
- Acronym
- ASIST
- Status last verified
- Apr 2025
- First submitted
- 16 Aug 2023
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Physiotherapist Supervised Training on Neuromuscular Control in Patients With Traumatic Anterior Shoulder Instability
- ClinicalTrials.gov ID
- NCT06033157
- Acronym / sponsor ID
- ASIST / ASIST-1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- 7 Nov 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 13 Sep 2023 (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 goal of this clinical trial is to investigate if physiotherapist supervised training improves neuromuscular control in patients suffering from traumatic anterior shoulder instability. The main question(s) it aims to answer are:
- Does physiotherapist supervised training improve shoulder neuromuscular control
- Does physiotherapist supervised training prevent recurring shoulder dislocations
- Is physiotherapist supervised training as good as surgery in improving shoulder neuromuscular control Participants will be randomised to either a training group or a no-training group.
Participants in the training group will undergo a 12 week training-program supervised by a physiotherapist.
Participants in the no-training group will receive a consultation with a shoulder surgeon, where information and general advice regarding the shoulder injury is provided.
Researchers will compare the training group to the no-training group to see if physiotherapist supervised training improves shoulder neuromuscular control in patients with traumatic anterior shoulder instability. The training group will also be compared to a historic group of patients with traumatic anterior shoulder instability, who underwent arthroscopic surgery.
Detailed description
- Aim: To investigate the effect of physiotherapist supervised training on shoulder neuromuscular control, and increase understanding of traumatic anterior shoulder instability.
- Main research questions:
A: Is supervised training in patients with traumatic anterior shoulder instability better in improving neuromuscular control, strength, apprehension and patient reported outcomes when compared to no training.
B: Is supervised training in patients with traumatic anterior shoulder instability better in preventing re-dislocations and need for surgical stabilisation when compared to no training.
C: Is supervised training in patients with traumatic anterior shoulder as good as Bankart surgery in improving neuromuscular control and patient reported outcome when compared to no training.
- Objectives for research question A:
To investigate if, in patients with traumatic anterior shoulder instability, a supervised 12-week training programme is better than no training in improving:
- Neuromuscular control
- Shoulder internal rotational strength
- Shoulder apprehension
- Patient reported outcomes
- Clinical shoulder instability Outcomes are measured at a) the end of the 12-weeks intervention and b) 6 months after the beginning of the intervention. Furthermore, patient reported outcomes is also measured at 1 and 2 years after the beginning of the intervention.
- Objective for research question B:
To investigate if, in traumatic anterior shoulder instability, a supervised 12-week training programme is better than no training in preventing a) re-dislocations and b) need for surgical stabilisation within the first 24 months.
- Objectives for research question C:
To investigate if, in patients with traumatic anterior shoulder instability, a specialised 12-week training programme is as good as arthroscopic Bankart surgery in improving:
- Neuromuscular control
- Shoulder internal rotational strength
- Shoulder apprehension
- Patient reported outcomes The training group is measured 6 months after the beginning of the intervention and the historic Bankart surgery group is measured 6 months after the surgery.
For all objectives neuromuscular control is investigated by determining a) shoulder joint position sense (JPS), b) shoulder reaction time, and c) shoulder sway length.
- Type of study: Pilot randomized controlled trial including 64 patients, which is allocated to either training og no-training (32 patients in each group).
- Time schedule: Recruitment and inclusion is planned to begin September 1st 2023 and is expected to last for 12-18 months. With a 2-year follow-up the complete study period is expected to last 3-3,5 years.
- Set-up: Patients presenting with shoulder instability in the outpatient clinic at Department of Orthopedic Surgery, Copenhagen University Hospital Hvidovre, will be recruited for the study. Patients who have signed an informed consent form will be randomised to either training- og no training-intervention and undergo examinations prior to, as well as three and six months after beginning of the intervention. All examinations will take place at the Copenhagen University Hospital Hvidovre. Patients in the training-group will be refered to training supervised by a physiotherapist. The training will take place at either Copenhagen University Hospital Hvidovre or a municipal rehabilitation center in Copenhagen. All examinations will include neuromuscular testing, accompanied by a clinical shoulder examination, strength measures and a validated electronic questionnaires regarding shoulder-related function. A pre-interventional 3D computed tomography scan will be performed to evaluate bone loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Active comparator | Behavioral: Physiotherapist supervised trainingA 12 week physiotherapist supervised training program |
| No-training | No intervention | –A short consultation with a designated orthopedic surgeon and a folder with general advice on how to avoid further dislocations and to relieve pain from the shoulder. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-40 years.
- Unilateral traumatic anterior shoulder instability.
- Willingness to adhere to the study protocol, herein attend follow-up.
- Ability to speak, read, and understand Danish.
- Ability to give written informed consent.
Key exclusion criteria (9 listed)
- Instability in the opposite shoulder.
- Off-track lesion.
- For both shoulders: Former or planned surgery.
- For both shoulders: posterior, multi-directional or atraumatic instability.
- For both shoulders: traumatic rotator cuff or biceps tendon tear.
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 |
|---|---|---|
| Physiotherapist supervised trainingA 12 week physiotherapist supervised training program. The patient will receive supervision by a physiotherapist 6 times during the intervention period. The patient is strongly encouraged to do the assigned training protocol at home 3 times a week. The supervised physiotherapy consists of introduction, review and progression of the assigned exercises. In addition, the patient will receive education and guidance in daily use of the arm and appropriate load on the shoulder. | Behavioural | Training |
Primary outcome
Neuromuscular control - Shouldersway
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
- Shoulder sway. Measured as sway-length (in millimeter).
8 secondary outcomes
Clinical examination - Shoulder instability
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Clinical examination - Shoulder range of motion
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Strength measure
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Apprehension measure
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Patient-reported outcome measures
Time frame: Will be tested prior to intervention and 3, 6, 12 and 24 months after the beginning of the intervention
Redislocations
Time frame: Will be tested 3, 6, 12 and 24 months after the beginning of the intervention
Neuromuscular control - Joint Position Sense
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Neuromuscular control - Reaction Time
Time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- 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.
Kristine R Andreasen, MD principal investigator
Copenhagen University Hospital, Hvidovre
Kristoffer W Barfod, MD, PhD study chair
Copenhagen University Hospital, Hvidovre
Kristoffer W Barfod, MD, PhD study director
Copenhagen University Hospital, Hvidovre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapist supervised training in people with Shoulder Instability Subluxation Bilateral, run by Hvidovre University Hospital at 1 site in Denmark.
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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
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?
Neuromuscular control - Shouldersway (time frame: Will be tested prior to intervention and 3 and 6 months after the beginning of the intervention). 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 15 Apr 2025.