Adhesive Capsulitis of the ShoulderNCT06766448
Effectiveness of Instrumental Rehabilitation in Patients With Adhesive Capsulitis
A study testing robotic training and conventionnal rehabilitation in people with Adhesive Capsulitis of the Shoulder, run by Mohammed V Souissi University at 1 site in Morocco.
Trial summary
The aim of this study is to evaluate the effectiveness of robotic training compared to conventional rehabilitation in patients with AC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder
- What is being tested?
- robotic training and conventionnal rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteMorocco
- Study dates
- 23 Mar 2021to Apr 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients >18 years of age
- Shoulder pain and/or movement limitation
- Idiopathic AC or associated with confirmed systemic disease (e.g., diabetes or dyslipidemia)
Who cannot join
- Cognitive impairment
- History of surgery
- Fracture or dislocation of the shoulder
- History of shoulder tendinopathy
- History of inflammatory or degenerative disease
- Infection
- Neurological disease (Parkinson's disease, stroke, multiple sclerosis, neurological
- Manipulation under anesthesia, hydro dilation, platelet rich plasma or hyaluronic acid infiltration within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Morocco1 site, 1 recruiting
- Recruiting
Faculty of medecine and pharmacy of rabat
Rabat, 10000
samia, s.karkouri@um5r.ac.ma
sara skalli, doctor
About this study
Official title: Robotic Training in the Management of Adhesive Capsulitis: a Randomized Controlled Trial
The aim of this study is to evaluate the effectiveness of robotic training compared to conventional rehabilitation in patients with AC.
Read the detailed description
Nowadays, rehabilitation focuses on functional work during physiotherapy sessions to improve the patient's autonomy.
In the era of new technologies, robotics and virtual reality have shown great interest in functional rehabilitation and cortical reorganization.
- Conditions
- Adhesive Capsulitis of the Shoulder
- Being tested
- robotic training, conventionnal rehabilitation
- Keywords
- adhesive capsulitis, rehabilitation, robotic training
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic trainingOther
continuous passive mobilization and robotic therapy on armeo sping
conventionnal rehabilitationOther
rehabilitation sessions with a physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | the intervention group will receive robotic training Receives: Other: robotic training |
| control group | Active comparator | control group will receive conventionnal rehabilitation Receives: Other: conventionnal rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder fonction using Shoulder Pain and Disability Index (SPADI)
It is a self-written questionnaire. It consists of twosubscales. The first assesses the importance of pain felt on five items. Pain scores range from 0 to 50. The second evaluates the difficulty of activities of daily living based on eight. Scores range from 0 to 80.questions
Measured: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Secondary outcomes (2)
pain using a visual analogue scale
It is a 100mm ruler that allows patients to rank their pain on a continuum from no pain to extreme pain. The patient places the indicator on a level that represents their current pain.
Measured: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Active and passive range of motion
Active and passive range of motion is clinically assessed using a goniometer while standing. We measured abduction, extension and external rotation.
Measured: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start23 Mar 2021
- Primary completion2 Jan 2025
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive Capsulitis of the ShoulderStudies 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
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed V Souissi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SARA SKALLI, Mohammed V Souissi University
- Investigators
- samia karkouri, professor, Study chair, Mohammed V Souissi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766448
- Sponsor's protocol ID
- C63-20
- Status last verified
- Jan 2025
- First submitted
- 4 Jan 2025
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: excell table of data
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Training in the Management of Adhesive Capsulitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06766448
- Acronym / sponsor ID
- C63-20
- Conditions
- Adhesive Capsulitis of the Shoulder
- Keywords
- adhesive capsulitis, rehabilitation, robotic training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Mohammed V Souissi UniversityUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- Apr 2025 (estimated)
- First posted
- 9 Jan 2025 (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 aim of this study is to evaluate the effectiveness of robotic training compared to conventional rehabilitation in patients with AC.
Detailed description
Nowadays, rehabilitation focuses on functional work during physiotherapy sessions to improve the patient's autonomy.
In the era of new technologies, robotics and virtual reality have shown great interest in functional rehabilitation and cortical reorganization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: robotic trainingthe intervention group will receive robotic training |
| control group | Active comparator | Other: conventionnal rehabilitationcontrol group will receive conventionnal rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients >18 years of age
- Shoulder pain and/or movement limitation
- Idiopathic AC or associated with confirmed systemic disease (e.g., diabetes or dyslipidemia)
Key exclusion criteria (8 listed)
- Cognitive impairment
- History of surgery
- Fracture or dislocation of the shoulder
- History of shoulder tendinopathy
- History of inflammatory or degenerative disease
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 |
|---|---|---|
| robotic trainingcontinuous passive mobilization and robotic therapy on armeo sping | Other | intervention group |
| conventionnal rehabilitationrehabilitation sessions with a physiotherapist | Other | control group |
Primary outcome
shoulder fonction using Shoulder Pain and Disability Index (SPADI)
Time frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
It is a self-written questionnaire. It consists of twosubscales. The first assesses the importance of pain felt on five items. Pain scores range from 0 to 50. The second evaluates the difficulty of activities of daily living based on eight. Scores range from 0 to 80.questions
2 secondary outcomes
pain using a visual analogue scale
Time frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
Active and passive range of motion
Time frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months
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 3 Feb 2025.
- Individual participant dataSharing planned: Yes. excell table of data
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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.
samia karkouri, professor study chair
Mohammed V Souissi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic training and conventionnal rehabilitation in people with Adhesive Capsulitis of the Shoulder, run by Mohammed V Souissi University at 1 site in Morocco.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 3 Feb 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 Morocco. 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?
Contact sara skalli, doctor (+212661504251, dr.skalli.sara@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder fonction using Shoulder Pain and Disability Index (SPADI) (time frame: at 3 weeks, 6 weeks, 3 months, 6 months, 9 months and 12 months). 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 3 Feb 2025.