- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07675759
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Department of Rehabilitation,Zhejiang University School of Medicine Second Affiliated Hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: controle
|
Participants will use a commercially available suspension shoulder sling for upper limb support during rehabilitation training and daily activities following cerebral infarction.
|
|
Experimenteel: experiment
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Acromiohumeral distance
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Muscle tone of biceps brachii, flexor digitorum superficialis, and flexor digitorum profundus
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- 2025-1699
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .