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

NCT04028999 | Completed

• 1 other identifier: RC31/17/0460
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebrovascular Accident

Keywords

Cerebrovascular Accident; sling; Upper limb impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Evaluate shoulder pain with Visual Analog Scale for Pain (EVA scale)

  24 hours

• Evaluate shoulder pain with EVA scale

  5 weeks

• Evaluate shoulder pain with EVA scale

  baseline

• Spasticity with TARDIEU scale

  baseline

• Spasticity with TARDIEU scale

  7 days

Study Arms (1)

the EO31 shoulder sling

EXPERIMENTAL

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

Interventions

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

the EO31 shoulder sling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de Toulouse

Toulouse, 31000, France

Location

Related Publications (1)

• 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 Oct;68(7):102014. doi: 10.1016/j.rehab.2025.102014. Epub 2025 Aug 21.

  PMID: 40845630 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Evelyne Castel-Lacanal, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 23, 2019
• Study Start: July 3, 2019
• Primary Completion: May 11, 2023
• Study Completion: September 1, 2023
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)