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

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

Study Overview

• Status: Unknown
• Conditions: Cerebrovascular Accident
• Intervention / Treatment: Device: Evaluate the effects of the EO31 shoulder sling in adults post-stoke

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

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evelyne Castel-Lacanal, MD; Phone Number: 33-5 61 32 21 20; Email: castel-lacanal.e@chu-toulouse.fr
• Study Contact Backup: Name: Evelyne Castel-Lacanal, MD

Study Locations

• France
  • Toulouse, France, 31000
    • Recruiting
    • Chu de Toulouse
    • Contact: Magalie Martin; Email: martin.m@chu-toulouse.fr
    • Principal Investigator: Evelyne Castel-Lacanal, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the EO31 shoulder sling; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
Number of daily use of the upper limb sling	Evaluate if patient use the sling : number of use by day	5 weeks
Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter	baseline
Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter	7 days
Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter	14 days
Clinical measure of appendage	Evaluate of appendage with clinical measure during all the treatment. This measure is in millimeter.	5 weeks
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Evelyne Castel-Lacanal, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2019
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 11, 2019
• First Submitted That Met QC Criteria: July 22, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2020
• Last Update Submitted That Met QC Criteria: November 6, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Cerebrovascular Accident; Upper limb impairment; sling
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: RC31/17/0460

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No