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

NCT ID: NCT04028999

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-03
• Study Completion Date: 2023-09-01

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

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Evelyne Castel-Lacanal, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de Toulouse

Toulouse, , France

Countries

France

References

Montane E, Pradie M, Bigarre I, Lebely C, Lelievre A, Cormier C, Butterworth J, Lepage B, Marque P, de Boissezon X, Castel-Lacanal E. A custom-made sling to achieve personal goals in shoulder pain or subluxation in the subacute stroke phase: a pilot study. Ann Phys Rehabil Med. 2025 Aug 21;68(7):102014. doi: 10.1016/j.rehab.2025.102014. Online ahead of print.

Reference Type: BACKGROUND

PMID: 40845630 (View on PubMed)

Other Identifiers

RC31/17/0460

Identifier Type: -

Identifier Source: org_study_id