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Multi-disciplinary Prevention Program

NCT02563431 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-02-09

No results posted yet for this study

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.

Conditions

Interventions

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)

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.

Sponsors & Collaborators

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Amandine COOK · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-09
Primary Completion
2016-08-30
Completion
2016-08-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02563431 on ClinicalTrials.gov