Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
76 participants
INTERVENTIONAL
2012-07-09
2016-08-30
Brief Summary
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Patient's actions are focus in 4 points:
* Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction)
* Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
* A training of the patient and members of family on pathology, risk, use of material
* Daily passive mobilisation of the upper member by a therapist.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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SP-ED
Classic use
SYSTAM - SP-ED
* Positioning in bed, wheelchair and standing with classics materials (pillow, holds, sling) on day J0 until J7 or Exit.
* Daily passive mobilisation of the upper member by a therapist.
* Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
4P-ED
Literature update
Ultrasling ER 15°Donjoy - 4P-ED
* Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction) on day J0 until J7 or Exit.
* A training of the patient and members of family on pathology, risk, use of material
* Daily passive mobilization of the upper member by a therapist.
* Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers) and active patient training for use the other side for support hemiplegic shoulder to prevent diastasis.
Interventions
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SYSTAM - SP-ED
* Positioning in bed, wheelchair and standing with classics materials (pillow, holds, sling) on day J0 until J7 or Exit.
* Daily passive mobilisation of the upper member by a therapist.
* Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)
Ultrasling ER 15°Donjoy - 4P-ED
* Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction) on day J0 until J7 or Exit.
* A training of the patient and members of family on pathology, risk, use of material
* Daily passive mobilization of the upper member by a therapist.
* Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers) and active patient training for use the other side for support hemiplegic shoulder to prevent diastasis.
Eligibility Criteria
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Inclusion Criteria
* Patient was admitted in a stroke unit until 48 h post stroke
* Locomotion :Medical Research Council scale ≤ 2 shoulder motility
* Spasticity : Ashworth scale ≤ 1 shoulder's adductor muscle
* Simple commands understanding: subtest 04 - Executive orders of Boston Diagnostic Aphasia Examination (BDAE)
Exclusion Criteria
* Shoulder disease background (stroke damage side)
* Depression background under 6 months as diagnosed according to DSM-IV
* Upper limb anesthesia
* Severe aphasia
18 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Amandine COOK
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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CHU Bordeaux
Bordeaux, , France
Countries
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Other Identifiers
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CHUBX 2011/17
Identifier Type: -
Identifier Source: org_study_id
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