Clinical trial NCT04028999: Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Official title: Implementation of Supportive Sling Device in Adults Post-stroke for Prevention of Shoulder Complications
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Cerebrovascular Accident
sling
Upper limb impairment
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale
timeFrame: 5 weeks
Secondary outcomes:
measure: Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)
timeFrame: 24 hours
measure: Evaluate shoulder pain with EVA scale
timeFrame: 5 weeks
measure: Evaluate shoulder pain with EVA scale
timeFrame: baseline
measure: Spasticity with TARDIEU scale
timeFrame: baseline
measure: Spasticity with TARDIEU scale
timeFrame: 7 days
measure: Spasticity with TARDIEU scale
timeFrame: 14 days
measure: Spasticity with TARDIEU scale
timeFrame: 5 weeks
measure: Number of daily use of the upper limb sling
timeFrame: 5 weeks
measure: Clinical measure of appendage
timeFrame: baseline
measure: Clinical measure of appendage
timeFrame: 7 days
measure: Clinical measure of appendage
timeFrame: 14 days
measure: Clinical measure of appendage
timeFrame: 5 weeks
measure: motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale
timeFrame: baseline
measure: motor function of upper limb with CAHAI scale
timeFrame: 7 days
measure: motor function of upper limb with CAHAI scale
timeFrame: 5 weeks
measure: questionnaire for quality of patient's life
timeFrame: baseline
measure: questionnaire for quality of patient's life
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Evelyne Castel-Lacanal, MD
role: PRINCIPAL_INVESTIGATOR
References: