- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05858892
Comparison of an Artificial Intelligence-Assisted Rehabilitation Program for Shoulder Musculoskeletal Disorders and the Clinical Decision Making of Therapists
May 5, 2023 updated by: Taipei Medical University Shuang Ho Hospital
People with shoulder musculoskeletal disorders among middle-aged and older adults have the highest need of rehabilitation services.
The population growth and aging society subsequently increase the number of disabled people, the healthcare costs and the needs for healthcare professionals.
The evidence exists to support the beneficial effect of exercises on function and quality of life.
Traditionally, a rehabilitation program is designed by therapists for each patient depending on their conditions.
In recent years, AI is increasingly being employed in the field of physical and rehabilitation medicine, however, there is no study of applying AI in predicting rehabilitation programs for shoulder musculoskeletal disorders.
The main purpose of this study is to explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders.
Twenty-three features are identified based on shoulder range of motion, pain, whether or not perform surgical procedure.
Each exercise is considered as a label with a total of twenty-five exercises.
Dataset is collected by clinical therapists to develop and train the model.
Each patient has to receive at least two months of rehabilitation and two times of evaluation.
Logistic regression, support vector machine and random forest are used to build the computational model.
Accuracy, precision, recall, F-1 score and AUC are used to evaluate the performance of the computational model in machine learning.
After training, we compare the consistency of rehabilitation programs predicted by using machine learning model and the clinical decision making of therapists.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hanyun Hsiao, master
- Phone Number: 1624 +88622490088
- Email: 10252@s.tmu.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan, 235
- Recruiting
- Shuang Ho Hospital
-
Contact:
- Hanyun Hsiao, master
- Phone Number: 1624 +88622490088
- Email: 10252@s.tmu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Musculoskeletal disorders that commonly cause shoulder pain in the clinic include Adhesive Capsulitis of shoulder (AC or frozen shoulder), Rotator Cuff Tear or Rupture (RCT), and Shoulder Impingement Syndrome (SIS).
The incidence of AC in the general population is approximately 2-5%, most commonly occurring in women aged 40-60 years; the incidence of RCT is 20.7% and increases with age, most commonly associated with SIS is the most frequent cause of shoulder pain, accounting for about 44-65% of cases, usually affecting people over the age of 40.
Description
Inclusion Criteria:
- The International Classification of Diseases, 10th revision (ICD-10) codes were selected before the study started and included the ICD-10 codes M75 (Shoulder lesions), S42 (Fracture of shoulder and upper arm), S43 (Dislocation and sprain of joints and ligaments of shoulder girdle), and S46 (Injury of muscle, fascia and tendon at shoulder and upper arm level)
- Patients who need rehabilitation after undergoing surgical procedure and are able to perform stretch, active assistive range of motion (AAROM) or supervised active range of motion (AROM)
- between 20-80 years old
- Are able to follow motor commands
Exclusion Criteria:
- Patients with central and peripheral nervous system disease, such as cerebrovascular accident (CVA), Parkinson's disease (PD), myasthenia gravis (MG), poliomyelitis
- Patients who had shoulder contusion, vascular injury, severe crush injury and amputation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
shoulder musculoskeletal group
The International Classification of Diseases, 10th revision (ICD-10) codes were selected before the study started and included the ICD-10 codes M75 (Shoulder lesions), S42 (Fracture of shoulder and upper arm), S43 (Dislocation and sprain of joints and ligaments of shoulder girdle), and S46 (Injury of muscle, fascia and tendon at shoulder and upper arm level)
|
usual care(rehabilitation program)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy
Time Frame: Change from Baseline at 2 months
|
To explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders
|
Change from Baseline at 2 months
|
Precision
Time Frame: Change from Baseline at 2 months
|
To explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders
|
Change from Baseline at 2 months
|
Recall
Time Frame: Change from Baseline at 2 months
|
To explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders
|
Change from Baseline at 2 months
|
F-1 score
Time Frame: Change from Baseline at 2 months
|
To explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders
|
Change from Baseline at 2 months
|
AUC
Time Frame: Change from Baseline at 2 months
|
To explore the possibilities of using supervised machine learning approach to predict rehabilitation programs for shoulder musculoskeletal disorders
|
Change from Baseline at 2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Burns DM, Leung N, Hardisty M, Whyne CM, Henry P, McLachlin S. Shoulder physiotherapy exercise recognition: machine learning the inertial signals from a smartwatch. Physiol Meas. 2018 Jul 23;39(7):075007. doi: 10.1088/1361-6579/aacfd9.
- Challoumas D, Biddle M, McLean M, Millar NL. Comparison of Treatments for Frozen Shoulder: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Dec 1;3(12):e2029581. doi: 10.1001/jamanetworkopen.2020.29581.
- Linsell L, Dawson J, Zondervan K, Rose P, Randall T, Fitzpatrick R, Carr A. Prevalence and incidence of adults consulting for shoulder conditions in UK primary care; patterns of diagnosis and referral. Rheumatology (Oxford). 2006 Feb;45(2):215-21. doi: 10.1093/rheumatology/kei139. Epub 2005 Nov 1.
- Oude Nijeweme-d'Hollosy W, van Velsen L, Poel M, Groothuis-Oudshoorn CGM, Soer R, Hermens H. Evaluation of three machine learning models for self-referral decision support on low back pain in primary care. Int J Med Inform. 2018 Feb;110:31-41. doi: 10.1016/j.ijmedinf.2017.11.010. Epub 2017 Nov 23.
- Gupta R, Srivastava D, Sahu M, Tiwari S, Ambasta RK, Kumar P. Artificial intelligence to deep learning: machine intelligence approach for drug discovery. Mol Divers. 2021 Aug;25(3):1315-1360. doi: 10.1007/s11030-021-10217-3. Epub 2021 Apr 12.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2022
Primary Completion (Anticipated)
April 30, 2024
Study Completion (Anticipated)
April 30, 2024
Study Registration Dates
First Submitted
May 5, 2023
First Submitted That Met QC Criteria
May 5, 2023
First Posted (Actual)
May 15, 2023
Study Record Updates
Last Update Posted (Actual)
May 15, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- N202206013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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