Multi-disciplinary Prevention Program (4P-ED)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SYSTAM - SP-ED
Ultrasling ER 15°Donjoy - 4P-ED
Sponsored by
About this trial
This is an interventional prevention trial for Stroke focused on measuring shoulder pain, prevention program
Eligibility Criteria
Inclusion Criteria:
- NIHSS : level of consciousness ≤ 1
- 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:
- Consciousness disorder (NIHSS>1)
- Shoulder disease background (stroke damage side)
- Depression background under 6 months as diagnosed according to DSM-IV
- Upper limb anesthesia
- Severe aphasia
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
SP-ED
4P-ED
Arm Description
Classic use
Literature update
Outcomes
Primary Outcome Measures
Change from baseline pain by a Visual Analog Scale
Pain is assessed by a physiotherapist thanks to VAS score.
Secondary Outcome Measures
Sensibility by a physiotherapist assessment
Sensibility is assessed by a physiotherapist, who does not know the treatment.
Change from baseline spasticity by ASHWORTH modified scale.
Spasticity is assessed by a physiotherapist thanks to ASHWORTH modified scale
Change from baseline locomotion by Medical Research Council scale.
Locomotion is assessed by a physiotherapist thanks to Medical Research Council scale.
Change from baseline depression by MADRS
Depression is assessed by a physiotherapist thanks to MADRS.
Change from baseline functional independence by Barthel Index measure
Functional independence is assessed by a physiotherapist thanks to Barthel Index measure.
Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires.
Full Information
NCT ID
NCT02563431
First Posted
July 30, 2015
Last Updated
February 8, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT02563431
Brief Title
Multi-disciplinary Prevention Program
Acronym
4P-ED
Official Title
Early Phase of Multi-disciplinary Prevention Program of Shoulder Pain Post-stroke
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2012 (Actual)
Primary Completion Date
August 30, 2016 (Actual)
Study Completion Date
August 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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:
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
shoulder pain, prevention program
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SP-ED
Arm Type
Active Comparator
Arm Description
Classic use
Arm Title
4P-ED
Arm Type
Experimental
Arm Description
Literature update
Intervention Type
Device
Intervention Name(s)
SYSTAM - SP-ED
Intervention Description
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)
Intervention Type
Device
Intervention Name(s)
Ultrasling ER 15°Donjoy - 4P-ED
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline pain by a Visual Analog Scale
Description
Pain is assessed by a physiotherapist thanks to VAS score.
Time Frame
Day 7 and month 2
Secondary Outcome Measure Information:
Title
Sensibility by a physiotherapist assessment
Description
Sensibility is assessed by a physiotherapist, who does not know the treatment.
Time Frame
at month 2
Title
Change from baseline spasticity by ASHWORTH modified scale.
Description
Spasticity is assessed by a physiotherapist thanks to ASHWORTH modified scale
Time Frame
Day 7 and at month 2
Title
Change from baseline locomotion by Medical Research Council scale.
Description
Locomotion is assessed by a physiotherapist thanks to Medical Research Council scale.
Time Frame
Day 7 and at month 2
Title
Change from baseline depression by MADRS
Description
Depression is assessed by a physiotherapist thanks to MADRS.
Time Frame
Day 7 and at month 2
Title
Change from baseline functional independence by Barthel Index measure
Description
Functional independence is assessed by a physiotherapist thanks to Barthel Index measure.
Time Frame
Day 7 and at month 2
Title
Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires.
Time Frame
after one third and two thirds subjects enclosed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
NIHSS : level of consciousness ≤ 1
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:
Consciousness disorder (NIHSS>1)
Shoulder disease background (stroke damage side)
Depression background under 6 months as diagnosed according to DSM-IV
Upper limb anesthesia
Severe aphasia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amandine COOK
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
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Multi-disciplinary Prevention Program
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