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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01464-37 | Other Identifier | ANSM |
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About 70% of hemiplegic patients suffer from hemiplegic shoulder pain after stroke. This common occurrence is a cause for concern in the rehabilitation setting as it leads to impairment of functional outcomes induced by discomfort and delays in rehabilitation, important psycho-emotional repercussions as there is a correlation between upper arm pain and depression, a longer hospital stay. Poor management of hemiplegic shoulder pain can ultimately give rise to type 1 "complex regional pain syndrome" (CRPS I). There is no consensus on treatment, care pathways or useful devices for positioning acute stroke patients in the literature. Our objective is to compare the effectiveness of a new positioning procedure of the hemiplegic arm with conventional positioning (pillow and "shoulder-immobilisation" sling) in acute stroke patients.
Patient's actions are focus in 4 points:
Shoulder pain is one of the four most frequently encountered after stroke complications. The importance of prevention isn't more to justify but it is not consensus on common conduct to follow.
Propose: a paramedical research protocol to improve the positioning of the hemiplegic shoulder in stroke unit and prevent shoulder pain acute stroke.
Objective: show the superiority of an approach to prevention of shoulder pain of patients post-stroke, in stroke unit.
A clinical trial, a comparative of superiority, monocentric, in two parallel groups is in included phase.
Investigators are initiating a study on new positioning devices providing optimal positioning of the hemiplegic shoulder according to the criteria given in the literature: elbow flexed at 40°, hand semi-prone, fingers abducted and in extension, and thumb in abduction. The medical devices under study are the SYSTAM'® positioning device for the upper-arm (spine position) and Ultrasling ER 15° DONJOY® (sitting or standing-up position). The study will include 30 acute stroke patients (ischemic or haemorrhagic) with no alertness problems and with a shoulder motor function score between 0 and 2 on the Held-scale. A visual analog scale (VAS) will be used, thus excluding patients with aphasia and dementia. The new positioning will be maintained for a maximum of 1 month or until the Held-scale score reaches 3. The primary end-point is pain (VAS) on Day 2, Day 7 and at 1 month. The secondary end-point is the National Institute of Health Stroke Score (NIHSS) at these times. Other variables are time (in hours) between patient arrival on the stroke ward and positioning, protocol compliance by staff and patients, and the percentage of patients with a diastasis on arrival and on discharge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SP-ED | Active Comparator | Classic use |
|
| 4P-ED | Experimental | Literature update |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYSTAM - SP-ED | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline pain by a Visual Analog Scale | Pain is assessed by a physiotherapist thanks to VAS score. | Day 7 and month 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Sensibility by a physiotherapist assessment | Sensibility is assessed by a physiotherapist, who does not know the treatment. | at month 2 |
| Change from baseline spasticity by ASHWORTH modified scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amandine COOK | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Bordeaux | Bordeaux | 33000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35505589 | Result | Glize B, Cook A, Benard A, Sagnier S, Olindo S, Poli M, Debruxelles S, Renou P, Rouanet F, Bader C, Dehail P, Sibon I. Early multidisciplinary prevention program of post-stroke shoulder pain: A randomized clinical trial. Clin Rehabil. 2022 Aug;36(8):1042-1051. doi: 10.1177/02692155221098733. Epub 2022 May 3. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Ultrasling ER 15°Donjoy - 4P-ED | Device |
|
|
Spasticity is assessed by a physiotherapist thanks to ASHWORTH modified scale
| Day 7 and at month 2 |
| Change from baseline locomotion by Medical Research Council scale. | Locomotion is assessed by a physiotherapist thanks to Medical Research Council scale. | Day 7 and at month 2 |
| Change from baseline depression by MADRS | Depression is assessed by a physiotherapist thanks to MADRS. | Day 7 and at month 2 |
| Change from baseline functional independence by Barthel Index measure | Functional independence is assessed by a physiotherapist thanks to Barthel Index measure. | Day 7 and at month 2 |
| Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires. | after one third and two thirds subjects enclosed |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |