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Completed

NCT Number: NCT02563431

Multi-disciplinary Prevention Program

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.

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Key information

Conditions

Stroke Arthralgia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYSTAM - SP-ED

Device
  • 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

Device
  • 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 outcomes

  1. 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.

Secondary outcomes

  1. Sensibility by a physiotherapist assessment

    Time frame: at month 2

    Sensibility is assessed by a physiotherapist, who does not know the treatment.

  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

  3. 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.

  4. Change from baseline depression by MADRS

    Time frame: Day 7 and at month 2

    Depression is assessed by a physiotherapist thanks to MADRS.

  5. 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.

  6. Caregivers staff knowledge of shoulder pain acute stroke by multiples choices questionnaires.

    Time frame: after one third and two thirds subjects enclosed

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Early Phase of Multi-disciplinary Prevention Program of Shoulder Pain Post-stroke

Acronym: 4P-ED

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 30, 2015
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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