Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications (EO31)

Toulouse University Hospital

Status: Unknown

Conditions: Cerebrovascular Accident

Treatments: Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke

Study type: Interventional

Funder types: Other

Identifiers

NCT04028999

RC31/17/0460

Details and patient eligibility

About

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function.

Full description

Upper limb (UL) impairment is a common deficit following stroke with only an estimated 20 per cent of patients recovering function. Pain associated with UL impairment due to multifactorial causes is a frequent symptom in patients with stroke. Occupational therapy techniques focus on the implementation of positioning techniques and the use of supportive devices (SD) such as slings aimed to prevent pain; therefore increase daily function, participation and hence quality of life. At present, positioning principles of the hemiplegic shoulder exist in clinical practice. These are aimed at prevention of pain associated with UL Impairment; however there is no clear consensus among professionals of particular SD that should be implemented for adults with stroke

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Having suffered in the last 6 months maximum a first stroke responsible for hemiplegia.
• Finding a clinical 5mm appendix, or with shoulder pain requiring prescription a scarf.
• Boston Diagnostic Aphasia Examination (BDAE) > 3.
• Consent of the patient
• Patient affiliated or benefiting from a social security scheme

Exclusion criteria

• Stroke recurrence, or stroke more than 6 months-old
• Patient already wearing a coaptation scarf
• Presence of lymphoedema, venous thrombosis of the upper limb
• Neoprene allergy
• Severe cognitive impairment: Mini-Mental State (MMS) <15
• Patient being part of another care protocol
• Adult under the protection of justice, tutors or curators
• Pregnant or lactating woman.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

the EO31 shoulder sling

Experimental group

Description:

To develop and evaluate the effects of the EO31 shoulder sling for the prevention of pain, subluxation, spasticity, as well as effect on increasing functional use of the UL in activities of daily living.

Treatment:

Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke