The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients

Stroke is a leading cause of long-term disability worldwide. During the early stage of recovery after cerebral infarction, reduced muscle tone and muscle weakness in the affected upper limb may lead to shoulder instability and shoulder subluxation, which can subsequently result in pain, limited range of motion, increased spasticity, and impaired upper extremity function. Early prevention of shoulder subluxation is therefore an important component of stroke rehabilitation.Proper positioning and external support of the affected upper limb may help maintain normal shoulder alignment, reduce gravitational traction on the shoulder joint, and prevent secondary complications. However, conventional sling-type shoulder supports have limitations in maintaining appropriate upper-limb positioning during different activities and postures.

This randomized controlled trial aims to evaluate the effectiveness and safety of a novel assistive device designed to prevent shoulder subluxation in patients with post-stroke hemiplegia. Eighty participants with first-ever cerebral infarction will be randomly assigned to either the intervention group, receiving the novel assistive device in addition to standard rehabilitation, or the control group, receiving a conventional sling shoulder support and standard rehabilitation. The primary outcome is acromiohumeral distance measured by ultrasonography. Secondary outcomes include muscle spasticity assessed by the Modified Ashworth Scale, joint range of motion, and upper extremity motor function. The findings of this study may provide evidence for the early prevention of shoulder subluxation and improve rehabilitation outcomes in patients with stroke.

Study Overview

• Status: Active, not recruiting
• Conditions: Hemiplegia and/or Hemiparesis Following Stroke
• Intervention / Treatment: Device: Commercially Available Shoulder Sling; Device: Novel Shoulder Subluxation Prevention Orthosis

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Department of Rehabilitation，Zhejiang University School of Medicine Second Affiliated Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of stroke with unilateral hemiplegia;
2. First-ever stroke;
3. Patient and/or legal guardian has been informed about the study and provides written informed consent;
4. Clinically stable condition.

Exclusion Criteria:

• 1. Severe cognitive impairment; 2. Malignant tumors; 3. Multiple organ failure; 4. Hemiplegia, joint contracture, muscle spasticity, shoulder subluxation, or neurological dysfunction caused by other etiologies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control	Device: Commercially Available Shoulder Sling; Participants will use a commercially available suspension shoulder sling for upper limb support during rehabilitation training and daily activities following cerebral infarction.
Experimental: experiment	Device: Novel Shoulder Subluxation Prevention Orthosis; Participants will use a novel assistive device designed to prevent shoulder subluxation during early rehabilitation after cerebral infarction. The device aims to provide shoulder support, maintain proper upper limb positioning, and reduce the risk of hemiplegic shoulder complications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acromiohumeral distance	The shortest vertical distance between the inferior border of the acromion and the superior aspect of the humeral head, measured by ultrasonography or/and X-ray to evaluate shoulder subluxation.	Baseline and up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle tone of biceps brachii, flexor digitorum superficialis, and flexor digitorum profundus	Assessment of muscle spasticity in the affected upper limb using the Modified Ashworth Scale.	Baseline and up to 3 weeks

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 3, 2028

Study Registration Dates

• First Submitted: May 29, 2026
• First Submitted That Met QC Criteria: June 23, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 23, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Early Rehabilitation; Hemiplegic; Motor Function Recovery; Limb Positioning
• Other Study ID Numbers: 2025-1699

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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