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

NCT07675759 | Active Not Recruiting

• 1 other identifier: 2025-1699
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemiplegia and/or Hemiparesis Following Stroke

Keywords

Hemiplegic; Early Rehabilitation; Limb Positioning; Motor Function Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Muscle tone of biceps brachii, flexor digitorum superficialis, and flexor digitorum profundus

  Baseline and up to 3 weeks

Study Arms (2)

control

ACTIVE COMPARATOR

Device: Commercially Available Shoulder Sling

experiment

EXPERIMENTAL

Device: Novel Shoulder Subluxation Prevention Orthosis

Interventions

Commercially Available Shoulder Sling DEVICE

Participants will use a commercially available suspension shoulder sling for upper limb support during rehabilitation training and daily activities following cerebral infarction.

control

Novel Shoulder Subluxation Prevention Orthosis DEVICE

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.

experiment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

Department of Rehabilitation，Zhejiang University School of Medicine Second Affiliated Hospital

Hangzhou, Zhejiang, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 30, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 3, 2028
• Last Updated: June 30, 2026

Record last verified: 2026-05

Locations

CN (1)