- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07635550
Assessment of 3D Angular Arm Velocity During Elevation in People With Subacromial Pain Syndrome Pre-post Rehabilitation: a Pilot Study (CoiFFaX)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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IDF
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Paris, IDF, Frankrike, 75014
- Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Subacromial pain syndrome
1
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Assessment of 3D angular arm velocity during elevation
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mean angular velocity norm in degrees per second
Tidsramme: Day 0
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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.
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Day 0
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Mean angular velocity norm in degrees per second
Tidsramme: 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.
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Day 21
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Velocity variation during movement time
Tidsramme: Day 0
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By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.
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Day 0
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Velocity variation during movement time
Tidsramme: Day 21
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By normalizing the cumulative velocity change by the highest frame-to-frame variation, this metric captures the overall irregularity of motion.
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Day 21
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Numeric Rating Scale
Tidsramme: Day 0
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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
Tidsramme: Day 21
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Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
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Day 21
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Quick DASH Questionnaire
Tidsramme: Day 0
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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)
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Day 0
|
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Quick DASH Questionnaire
Tidsramme: Day 21
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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)
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Day 21
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SPADI self-administered questionnaire
Tidsramme: Day 0
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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).
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Day 0
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SPADI self-administered questionnaire
Tidsramme: Day 21
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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).
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Day 21
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FABQ self-administered questionnaire on shoulder pain
Tidsramme: Day 0
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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)
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Day 0
|
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FABQ self-administered questionnaire on shoulder pain
Tidsramme: 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)
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Day 21
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- APHP260761
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