- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07635550
Assessment of 3D Angular Arm Velocity During Elevation in People With Subacromial Pain Syndrome Pre-post Rehabilitation: a Pilot Study (CoiFFaX)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
IDF
-
Paris, IDF, Frankrike, 75014
- Service de Rééducation et de Réadaptation de l'Appareil Locomoteur et des Pathologies du Rachis, Hôpital Cochin
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Subacromial pain syndrome
1
|
Assessment of 3D angular arm velocity during elevation
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean angular velocity norm in degrees per second
Tidsram: 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.
|
Day 0
|
|
Mean angular velocity norm in degrees per second
Tidsram: Day 21
|
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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Numeric Rating Scale
Tidsram: Day 0
|
Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
|
Day 0
|
|
Numeric Rating Scale
Tidsram: Day 21
|
Pain intensity assessed on a Numeric Rating Scale (NRS, 0-100, 0: no pain, 100: maximum pain imaginable)
|
Day 21
|
|
Quick DASH Questionnaire
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- APHP260761
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