Multi-disciplinary Prevention Program (4P-ED)

May 27, 2026 updated by: University Hospital, Bordeaux

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • CHU Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: SP-ED
Classic use
Device: 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)
Experimental: 4P-ED
Literature update
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 7 and month 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensibility by a physiotherapist assessment
Time Frame: at month 2
Sensibility is assessed by a physiotherapist, who does not know the treatment.
at month 2
Change from baseline spasticity by ASHWORTH modified scale.
Time Frame: Day 7 and at month 2
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.
Time Frame: Day 7 and at month 2
Locomotion is assessed by a physiotherapist thanks to Medical Research Council scale.
Day 7 and at month 2
Change from baseline depression by MADRS
Time Frame: Day 7 and at month 2
Depression is assessed by a physiotherapist thanks to MADRS.
Day 7 and at month 2
Change from baseline functional independence by Barthel Index measure
Time Frame: Day 7 and at month 2
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.
Time Frame: after one third and two thirds subjects enclosed
after one third and two thirds subjects enclosed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Amandine COOK, University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2012

Primary Completion (Actual)

August 30, 2016

Study Completion (Actual)

August 30, 2016

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

September 29, 2015

First Posted (Estimated)

September 30, 2015

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2011/17
  • 2011-A01464-37 (Other Identifier: ANSM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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