Effects of pressure garments of varying designs on upper extremity sensorimotor functions and quality of life after stroke: Study protocol for a multicenter, double-blind, prospective randomized controlled trial

 Of course your incompetent? doctors therapists and hospital DID NOTHING with this previous one. And will continue to prove incompetence with this newest research!

Regent Suit and stroke rehabilitation March 2011 

 In my opinion competence is immediately installing protocols upon published research. Does your incompetent? doctor think that is too high a bar? FIRE THEM! And if your doctor is still there after doing nothing your board of directors is completely incompetent!

The latest here: 

Effects of pressure garments of varying designs on upper extremity sensorimotor functions and quality of life after stroke: Study protocol for a multicenter, double-blind, prospective randomized controlled trial

nd, prospective randomized controlled trial Zhenkun Xu1, Siaw Chui Chai 1*, Shin Ying Chu2, Kuicheng Li3 1 Center for Rehabilitation and Special Needs Studies, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia, 2 Center for Health Ageing and Wellness, Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Kuala Lumpur, Malaysia, 3 School of Rehabilitation Medicine, Shandong Second Medical University, Weifang, China * sc.chai@ukm.edu.my 

 Abstract 

 Rationale 

Stroke often results in extensive neurological damage, leading to a wide range of rehabilitation needs and challenges, with upper extremity dysfunction being particu larly prevalent. Although pressure garments have been used in the rehabilitation of children with cerebral palsy to reduce muscle tone, their therapeutic effects have not been thoroughly investigated in the field of stroke. 

 Aims 

 To determine the effects of pressure garments with varying designs on stroke patients’ sensorimotor function and quality of life. Sample size estimate A total of 165 participants is required (55/group) with an effect size of 0.125, power of 0.80, alpha level of 0.05, and adjusted for a dropout rate of 20%. 

 Methods and design 

 This is a multicenter, double-blind, prospective randomized controlled, three-group trial. At three hospitals in Shandong, China, 165 patients within 1−12 months of stroke are randomly assigned (1:1:1) to receive Dorsal-Double-layered 10% cir cumferential reduction (DD-10, intervention), Single-layered 10% circumferential reduction (S-10, intervention), or Single-layered 0% circumferential reduction (S-0, placebo) pressure garments. Pressure garments are worn for 3 hours in the morning, 3 hours in the afternoon, and 8 hours at night daily for 8 weeks. During the first 4 weeks, patients also receive 30-min occupational therapy sessions. 

 Study outcomes 

 The primary outcome is the Fugl-Meyer Assessment of Upper Extremity to assess motor control. Secondary outcomes are the Box and Block Test (BBT) for assessing dexterity, Modified Ashworth Scale (MAS) for assessing muscle tone, Visual Ana logue Scale for assessing pain, Disabilities of Arm, Shoulder, and Hand (DASH) for assessing self-perceived upper extremity function, and 36 Item Short Health Survey (SF-36) for assessing quality of life. Measurements are taken at Time 1(Baseline), Time 2 (Week 4), and Time 3 (Week 8). (None of these are objective, so any results you get are not repeatable!)

 Discussion 

 The expected outcome of this study is that it can determine the design of pressure garments best suited to improve sensorimotor function and the quality of life of stroke patients. It can also extend the clinical value of pressure garments and help health care professionals make more targeted treatment choices for stroke patients. 

 Trial registration ClinicalTrials.gov Identifier: NCT06587308. 

 Introduction 

 Stroke is a challenging neurological disorder worldwide and remains the second leading cause of death and disability in the world [1]. In China, the estimated prev alence, incidence, and mortality rate of stroke among adults aged 40 years or older in 2020 were 2.6%, 505.2/100,000 person-years, and 343.4/100,000 person-years, respectively [2]. Stroke often results in extensive neurological damage, leading to a wide range of rehabilitation needs and challenges, with upper extremity dysfunction being prevalent [3–5]. This dysfunction includes impaired sensorimotor function with abnormal muscle tone, pain, poor dexterity, etc., eventually affecting quality of life. A pressure garment is an external tool made of elastic material, commonly Lycra, that applies pressure to improve swelling, inhibit scarring, and enhance motor perfor mance [6,7]. In sports, moderate pressure may enhance blood circulation and reduce poor venous return and muscle fatigue, increasing comfort and athletic performance [8]. Concerning muscle tone, pressure garments are thought to provide neutral heat by reducing spasms through prolonged stretching and skin irritation from tight skin contact [9]. By reducing the high muscle tone of the spastic muscles, the application of pressure to the damaged limb allows for better control of the antagonistic muscles [7]. The uniform pressure applied by pressure garments may also modulate sensory input and improve joint position sense and body awareness by stimulating mechano receptors [10]. Although it is used in the rehabilitation of children with cerebral palsy 2 / 10 PLOS One | https://doi.org/10.1371/journal.pone.0326680 June 23, 2025 for the reduction of muscle tone [11], its therapeutic effects have not been fully confirmed in the field of stroke. Cerebral palsy and stroke, although they may exhibit the characteristics of elevated spasticity and dyskinesia, create similar prob lems with upper extremity function; application of evidence gathered from cerebral palsy to stroke rehabilitation requires cautious attention. Since cerebral palsy involves still-developing muscles, stroke involves fully matured muscles [12], a specific research on stroke is essential to ensure safe and effective pressure garment applications in stroke rehabilitation. The effects of pressure garments on upper extremity functions after stroke are limited and controversial. Gracies et al. [13] designed a crossover trial that included a total of 16 patients (36–85 years old; > 3 weeks of stroke) with hemiparesis and upper extremity spasticity and found that wearing a Lycra garment for 3 hours improved wrist posture and reduced wrist and finger flexor spasticity. Conversely, Ooi et al. (2020) [14] found no difference in arm spasticity and function after 6 hours per day, 6-week pressure garment applications. However, verbal feedback informed that the pressure garment allows greater finger extension to facilitate grasping and releasing movements. According to Ooi et al. (2020) [14], this fail ure is likely due to insufficient wearing time, inappropriate design, and small sample size. For future studies, besides using larger sample size, they also suggested to add an extra Lycra on the pressure garment’s dorsal aspect, extending the coverage proximally beyond the elbow joint, and prolonging its wearing time to improve the extension force [14]. According to this recommendation [14], our study is designed to gather more substantiate evidence to support pressure garment clinical usage in stroke rehabilitation. Objectives The primary objective of this study is to determine the effects of pressure garments with varying designs (i.e., Dorsal- Double-layered 10% circumferential reduction; Single-layered 10% circumferential reduction; and Single-layered 0% circumferential reduction) on sensorimotor function, including motor control, dexterity, muscle tone, pain, self-perceived upper extremity function and quality of life in stroke patients after 8 weeks of intervention. Hypotheses There is a difference between the effects of DD-10, S-10, & S-0 PG on motor control, dexterity, muscle tone, pain, self-perceived upper extremity function as measured by Fugl-Meyer Assessment of Upper Extremity [15], Box and Block Test (BBT), Modified Ashworth Scale (MAS), Visual Analogue Scale, Disabilities of Arm, Shoulder, and Hand (DASH), and 36 Item Short Health Survey (SF-36), respectively, among stroke patients during 8 weeks of application. Having an extra piece of fabric on the dorsal side, DD-10 is expected to provide stronger power of extension to the patient’s hand, wrist, and elbow, thus helping open the flexed upper extremity for better sensorimotor performance.

More at link.