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
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Zhejiang
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Hangzhou, Zhejiang, China
- Department of Rehabilitation，Zhejiang University School of Medicine Second Affiliated Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: control
|
Participants will use a commercially available suspension shoulder sling for upper limb support during rehabilitation training and daily activities following cerebral infarction.
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Experimental: experiment
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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
Time Frame: Baseline and up to 3 weeks
|
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
Time Frame: Baseline and up to 3 weeks
|
Assessment of muscle spasticity in the affected upper limb using the Modified Ashworth Scale.
|
Baseline and up to 3 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-1699
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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