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临床试验/NCT05626790
NCT05626790已完成不适用

The Comparison of the Effects of PNF and Static Stretching Applied to the Elbow Flexors on Muscle Architecture and Viscoelastic Properties In Individuals With Chronic Stroke

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 34 人开始时间: 2022年11月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
34
试验地点
2
主要终点
Muscle architecture

研究概览

简要总结

The patients who were diagnosed with stroke in governmental/university/private hospitals, and who needed rehabilitation because of the increased flexor tone in the elbow joint, decreased range of motion and/or decreased function of the upper extremity will be invited to the study in accordance with the criteria that are given in inclusion and exclusion part. Participants will be randomly assigned to one of two parallel groups, either the PNF Stretching Group (n=17) or the Prolonged Stretching Group (n=17), according to the order of participation in the study by simple randomization. An online computer program will be used to assign participants (https://www.randomizer.org/). Exercises that will increase proximal stabilization and control will be applied to both groups for 4 weeks, 5 days a week. In addition to the exercises, prolonged stretches for 10 minutes will be applied to the Prolonged Stretching Group, and PNF stretching will be applied to the PNF Stretching Group. At the beginning and the end of the study, muscle architecture, muscular viscoelastic properties, range of motion, proprioception, upper extremity motor performance and function and posture will be evaluated.

详细描述

Flexion synergy is common in the upper extremities of patients with hemiplegia after a stroke, and the elbow is involuntarily held in the flexion posture with the effect of increased flexor tone in the elbow. Over time, weakness in the hemiparetic arm, motor disturbances caused by abnormal synergies, and persistent spasticity begin to cause secondary changes in the musculoskeletal system that may limit the use of the arm and affect functional mobility; soft tissue shortening and contracture formations can be seen. Studies show that static stretching can lead to a significant change in the number of sarcomeres. However, considering the nature of spasticity, which is one of the most common complications in stroke patients, stretching should be done slowly and for a long time. This may lead to an increase in the time spent by patients in the clinic. At the same time, since it can be painful for some patients, it can increase spasticity rather than reduce it. In addition, hand contact is not frequent during prolonged stretches, which has proven to increase the positive effects of rehabilitation, and may result in a decrease in the maximum impact that will occur during rehabilitation.

There is positive evidence that Proprioceptive Neuromuscular Facilitation (PNF) stretching, another stretching method, reduces both muscle and muscle-tendon unit tension more than static stretching in healthy individuals and can lead to a more effective lengthening of muscle fascicles compared to static stretching. In addition, it does not contain the adverse effects of static stretching because it requires hand contact and is applied with active contraction of the patient. Considering this situation, we hypothesized that PNF stretching, which will be used in stroke rehabilitation, may be an ideal rehabilitation method for optimizing muscle fascicle length as well as inhibiting elbow flexion posture by providing tone regulation and thus reducing stiffness in the muscles. Sample size calculation was done by GPower 3.1. A total of 34 hemiplegic patients will be invited to the study and divided into 2 groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stroke diagnosed by magnetic resonance imaging or computed tomography, regardless of ischemic or hemorrhagic origin;
  • Hemiplegia caused only by stroke;
  • At least 3 months have passed since the diagnosis of stroke;
  • At least 1+ spasticity according to Modified Ashworth Scale in the elbow flexors of the affected side;
  • Ability to maintain sitting balance for at least 20 seconds without support;
  • Being older than 18 years old;
  • Being voluntary to participate in the study.

排除标准

  • Having a history of multiple strokes or bilateral involvement;
  • Botox application to any/all of the Biceps, Brachialis or Brachioradialis muscles within the last 6 months;
  • Changes in pharmacological treatment in the last 6 months;
  • Muscle involvement on the affected side that completely prevents the elbow joint range of motion;
  • Presence of conditions that may affect the level of spasticity (infection, febrile illness, etc.)
  • Mini Mental State Assessment Test score below 24;
  • Presence of neurological diagnosis other than stroke;
  • Insufficient vision, hearing and/or understanding ability to administer assessments and treatments.

结局指标

主要结局

Muscle architecture

时间窗: 1 month

The Epiq Elite Ultrasound System (Philips, Bothell, WA, USA) will be used to evaluate the muscle architecture (muscle thickness-MT, pennation angle-PA, fascicle length-FL and echogenicity-EG) of the elbow flexors (Biceps Brachii, Brachioradialis, Brachialis). We expect to observe a decrease in MT, PA, EG and increase in FL. Measurements will be taken in the supine position both in the relaxed position of the muscles with the elbow flexed to 90 degrees, the forearm and wrist supported in the neutral position, and after waiting for 30 seconds in the maximum extension position allowed by the elbow joint range of motion. Measurements will be taken 1 cm proximal to the cubital line for the Brachialis muscle, one-third of the distance between the cubital fossa and the acromion for the Biceps brachii muscle, and one-third of the distance between the lateral epicondyle of the humerus and the ulnar styloid process for the Brachioradialis muscle. The same radiologist will make measurements.

Muscle viscoelastic properties

时间窗: 1 month

Myoton®PRO Digital Palpation Device (Myoton AS, Tallinn, Estonia) will be used to measure biceps brachii and Brachioradialis muscle tone, stiffness and elasticity. Measurements will be made at the most bulging points of the Biceps Brachii and Brachioradialis muscles and repeated 3 times. Measurements will be taken at rest, during maximum voluntary contraction, stretching and active reaching. We expect to observe a decrease in tone (decreased F value) and stiffness (decreased S value), and increase in elasticity (decreased D value).

次要结局

  • Range of Motion(1 month)
  • Proprioception(1 month)
  • Upper extremity motor performance(1 month)
  • Upper extremity motor function(1 month)
  • Photographic posture measurement(1 month)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayse Zengin Alpozgen

Assoc. Prof.

Istanbul University - Cerrahpasa

研究点 (2)

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