Novel elbow-forearm support orthosis for post-stroke glenohumeral subluxation: a randomized controlled trial protocol

Background: Glenohumeral subluxation (GHS) is a common complication following stroke, with an incidence rate of up to 73% in the acute phase, significantly impairing upper limb functional recovery and activities of daily living. Conventional support devices, such as the Harris hemiplegic sling and Bobath sling, have limitations including tendency to slip and displacement, resulting in incomplete reduction. To address these challenges, our research team has developed a novel 3D-printed elbow-forearm support orthotic device. Methods: This study employs a single-center, prospective, assessor-blinded randomized controlled trial design. We plan to recruit 60 post-stroke patients with GHS, who will be randomly allocated to either the intervention group (elbow-forearm support orthosis) or the control group (conventional shoulder sling). The intervention period is 4 weeks with 6 h of daily wear, followed by an 8-week follow-up period (total observation period of 12 weeks). The primary outcome measures are vertical distance (VD) and horizontal distance (HD) from the inferior margin of the acromion to the center of the humeral head. Secondary outcome measures include the Modified Ashworth Scale, Visual Analog Scale for pain, Fugl-Meyer Assessment for upper extremity motor function, and Modified Barthel Index. Statistical analysis will be performed using mixed-effects linear models. Discussion: The elbow-forearm support orthosis improves GHS through mechanisms including biomechanical support and neuromuscular modulation. This study employs standardized radiographic measurements, multidimensional assessment systems, and rigorous randomization design, which may provide high-quality evidence-based medicine for the treatment of post-stroke GHS. Study limitations include single-center design and limited sample size, necessitating multicenter large-scale studies for validation. Clinical trial registration: https://www.chictr.org.cn/, identifier ChiCTR1800018730.