Stroke4P-EDNCT02563431
Multi-disciplinary Prevention Program
A study testing SYSTAM - SP-ED and Ultrasling ER 15°Donjoy - 4P-ED in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- SYSTAM - SP-ED and Ultrasling ER 15°Donjoy - 4P-ED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2012to 30 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Phase of Multi-disciplinary Prevention Program of Shoulder Pain Post-stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- SYSTAM - SP-ED, Ultrasling ER 15°Donjoy - 4P-ED
- Keywords
- shoulder pain, prevention program
- Medical subject headings
- Stroke, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYSTAM - SP-EDDevice
- 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-EDDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| SP-ED | Active comparator | Classic use Receives: Device: SYSTAM - SP-ED |
| 4P-ED | Experimental | Literature update Receives: Device: Ultrasling ER 15°Donjoy - 4P-ED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline pain by a Visual Analog Scale
Pain is assessed by a physiotherapist thanks to VAS score.
Measured: Day 7 and month 2
Secondary outcomes (6)
Sensibility by a physiotherapist assessment
Sensibility is assessed by a physiotherapist, who does not know the treatment.
Measured: at month 2
Change from baseline spasticity by ASHWORTH modified scale.
Spasticity is assessed by a physiotherapist thanks to ASHWORTH modified scale
Measured: 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.
Measured: Day 7 and at month 2
Change from baseline depression by MADRS
Depression is assessed by a physiotherapist thanks to MADRS.
Measured: 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.
Measured: Day 7 and at month 2
Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires.
Measured: after one third and two thirds subjects enclosed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study start9 Jul 2012
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amandine COOK, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563431
- Sponsor's protocol ID
- CHUBX 2011/17
- Other IDs
- 2011-A01464-37
- Acronym
- 4P-ED
- Status last verified
- Feb 2022
- First submitted
- 30 Jul 2015
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35505589
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Phase of Multi-disciplinary Prevention Program of Shoulder Pain Post-stroke
- ClinicalTrials.gov ID
- NCT02563431
- Acronym / sponsor ID
- 4P-ED / CHUBX 2011/17
- Conditions
- Stroke
- Keywords
- shoulder pain, prevention program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 9 Jul 2012 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SP-ED | Active comparator | Device: SYSTAM - SP-EDClassic use |
| 4P-ED | Experimental | Device: Ultrasling ER 15°Donjoy - 4P-EDLiterature update |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Device | SP-ED |
| 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. | Device | 4P-ED |
Primary outcome
Change from baseline pain by a Visual Analog Scale
Time frame: Day 7 and month 2
Pain is assessed by a physiotherapist thanks to VAS score.
6 secondary outcomes
Sensibility by a physiotherapist assessment
Time frame: at month 2
Change from baseline spasticity by ASHWORTH modified scale.
Time frame: Day 7 and at month 2
Change from baseline locomotion by Medical Research Council scale.
Time frame: Day 7 and at month 2
Change from baseline depression by MADRS
Time frame: Day 7 and at month 2
Change from baseline functional independence by Barthel Index measure
Time frame: Day 7 and at month 2
Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires.
Time frame: after one third and two thirds subjects enclosed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 35505589Glize 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amandine COOK principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SYSTAM - SP-ED and Ultrasling ER 15°Donjoy - 4P-ED in people with Stroke, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline pain by a Visual Analog Scale (time frame: Day 7 and month 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02563431, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.