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New orthosis aims to stop shoulder dislocation in stroke survivors

NCT ID NCT07675759

Prevention Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests a new shoulder support device designed to prevent shoulder subluxation (partial dislocation) in people who have had a stroke and have weakness on one side. Eighty first-time stroke patients will use either the new device or a standard sling during early rehabilitation. The goal is to see if the new device better maintains shoulder alignment and reduces complications like pain and stiffness.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Novel shoulder subluxation prevention orthosis
What this could lead to
If effective, this device could become a standard tool to prevent shoulder complications and improve arm function after stroke.
What could go wrong
This is a small, early-stage trial with 80 participants, so results may not apply to all stroke patients. The device may not outperform conventional slings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemiplegia and/or hemiparesis following stroke

Contacts and locations

Locations

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

    Hangzhou, Zhejiang, China

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