CompletedNot Applicable

Multi-disciplinary Prevention Program

France76 participantsStarted 2012-07-09

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline pain by a Visual Analog Scale

Timeframe: Day 7 and month 2

Trial details

NCT IDNCT02563431

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08-30

View on ClinicalTrials.gov More Stroke trials