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

Cerebrovascular Accident Clinical Trial

— EO31  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04028999
• Other study ID #: RC31/17/0460
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2019
• Est. completion date: December 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: Evelyne Castel-Lacanal, MD
• Phone: 33-5 61 32 21 20
• Email: castel-lacanal.e[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Device:
• Evaluate the effects of the EO31 shoulder sling in adults post-stoke
Investigator want to evaluate the efficient of the EO31 shoulder sling in adults post-stroke. The EO31 shoulder sling is made-to-measure shoulder pads for upper limb after cerebrovascular accident

Locations

Country	Name	City	State
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effects of the EO31 shoulder with Goal Attainment Scale (GAS) scale	GAS (Goal Attainment Scale) scores will be described with regards to the 3 client-centred objectives. The score for each objective is comprised between -2 (when objective is not achieve) to 2 (achieve objective).	5 weeks
Secondary	Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)	The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain)	24 hours
Secondary	Evaluate shoulder pain with EVA scale	The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).	5 weeks
Secondary	Evaluate shoulder pain with EVA scale	The shoulder pain will be evaluate with th sling with EVA Scale. Eva scale is between 0 (no pain) to 10 (big pain).	baseline
Secondary	Spasticity with TARDIEU scale	Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured	baseline
Secondary	Spasticity with TARDIEU scale	Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured	7 days
Secondary	Spasticity with TARDIEU scale	Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured	14 days
Secondary	Spasticity with TARDIEU scale	Evaluate the spasticity of upper limb with TARDIEU scale: the rotation angle of the shoulder, elbow and wrist are measured	5 weeks
Secondary	Number of daily use of the upper limb sling	Evaluate if patient use the sling : number of use by day	5 weeks
Secondary	Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter	baseline
Secondary	Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter	7 days
Secondary	Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter	14 days
Secondary	Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.	5 weeks
Secondary	motor function of upper limb with Chedoke Arm and Hand Activity Inventory (CAHAI) scale	the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)	baseline
Secondary	motor function of upper limb with CAHAI scale	the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)	7 days
Secondary	motor function of upper limb with CAHAI scale	the motor function of the upper limb will be evaluate with CAHAI scale between 13 (motor function low) to 94 (motor function strong)	5 weeks
Secondary	questionnaire for quality of patient's life	the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)	baseline
Secondary	questionnaire for quality of patient's life	the quality of patient's life will be evaluate with ESAT scale between 0 (quality of life low) and 60 (good quality of life)	5 weeks