- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07635550
Assessment of 3D Angular Arm Velocity During Elevation in People With Subacromial Pain Syndrome Pre-post Rehabilitation: a Pilot Study (CoiFFaX)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Current clinical assessment of shoulder pain focus on range of motion (RoM), clinical tests and disability, but lack information on shoulder performance. Shoulder performance is an imprecise multidimensional concept including RoM, accuracy, smoothness, and velocity. Clinicians need simple and accurate methods to measure shoulder performance.
Rotator cuff lesions are the most common shoulder pathologies. These pathologies include a wide range of soft-tissue conditions surrounding the humeral head that are grouped under the term subacromial pain syndrome (SPS). SPS is associated with pain, decreased active shoulder elevation, activity limitation and decreased quality of life. Physiotherapy is the first-line treatment for chronic SPS for pain and function.
Inertial measurement units (IMUs) have been used to assess velocity variables in people with SPS. The intra- and inter-observer reliability of kinematic temporal variables measured using IMUs is excellent in people with shoulder disorders. Most studies assessed functional arm activities rather than analytic arm elevation movements that are typically evaluated in clinical practice. Furthermore, they used rather complex kinematic temporal parameters (cumulative velocity distribution, power, moment or asymmetry scores) that can lack interpretability for clinicians. We wanted to employ accurate and clinically meaningful velocity variables used to assess arm movements during standard clinical shoulder examinations.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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IDF
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Paris, IDF, France, 75014
- Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥18 years,
- unilateral SPS diagnosed by a physician using clinical tests and imaging,
- enrolled in a usual care 4-session rehabilitation program in the PMR outpatient department.
Exclusion Criteria:
- shoulder fracture or dislocation or shoulder surgery (with implant) <1 year previously,
- SLAP lesion,
- neurological pathology,
- cervico-brachial neuralgia.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Subacromial pain syndrome
1
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Assessment of 3D angular arm velocity during elevation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean angular velocity norm in degrees per second
Time Frame: Day 0
|
The angular velocity norm provides a measure of velocity during arm elevation, taking into account the 3 movement axes and not only the main movement axis.
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Day 0
|
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Mean angular velocity norm in degrees per second
Time Frame: Day 21
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The angular velocity norm provides a measure of velocity during arm elevation, taking into account the 3 movement axes and not only the main movement axis.
|
Day 21
|
|
Velocity variation during movement time
Time Frame: Day 0
|
By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.
|
Day 0
|
|
Velocity variation during movement time
Time Frame: Day 21
|
By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.
|
Day 21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numeric Rating Scale
Time Frame: Day 0
|
Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
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Day 0
|
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Numeric Rating Scale
Time Frame: Day 21
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Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
|
Day 21
|
|
Quick DASH Questionnaire
Time Frame: Day 0
|
Measurement of disability and symptoms of musculoskeletal disorders related to upper limb impairment (DASH self-report questionnaire; 30 = no functional impairment to 150 = maximum impairment)
|
Day 0
|
|
Quick DASH Questionnaire
Time Frame: Day 21
|
Measurement of disability and symptoms of musculoskeletal disorders related to upper limb impairment (DASH self-report questionnaire; 30 = no functional impairment to 150 = maximum impairment)
|
Day 21
|
|
SPADI self-administered questionnaire
Time Frame: Day 0
|
Pain and disability (SPADI self-administered questionnaire), pain subscore (0: no pain, 50: maximum imaginable pain) and disability subscore (0: no disability, 80: maximum signs of disability).
|
Day 0
|
|
SPADI self-administered questionnaire
Time Frame: Day 21
|
Pain and disability (SPADI self-administered questionnaire), pain subscore (0: no pain, 50: maximum imaginable pain) and disability subscore (0: no disability, 80: maximum signs of disability).
|
Day 21
|
|
FABQ self-administered questionnaire on shoulder pain
Time Frame: Day 0
|
Misconceptions and apprehension regarding physical activities and work (FABQ-Shoulder self-report questionnaire), physical activities subscore (questions 2, 3, 4, 5: 0 = no apprehension/misconceptions, 24 = maximum signs of apprehension/misconceptions) and work subscore (questions 6, 7, 9, 10, 11, 12, 15: 0 = no apprehension/misconceptions, 42 = maximum signs of apprehension/misconceptions)
|
Day 0
|
|
FABQ self-administered questionnaire on shoulder pain
Time Frame: Day 21
|
Misconceptions and apprehension regarding physical activities and work (FABQ-Shoulder self-report questionnaire), physical activities subscore (questions 2, 3, 4, 5: 0 = no apprehension/misconceptions, 24 = maximum signs of apprehension/misconceptions) and work subscore (questions 6, 7, 9, 10, 11, 12, 15: 0 = no apprehension/misconceptions, 42 = maximum signs of apprehension/misconceptions)
|
Day 21
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- APHP260761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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