Clinical trial NCT02390115: Effects of Elastic Tape in Shoulder Movements in Hemiparetic Subjects
Official title: Effects of Elastic Tape in Proprioception and Performance of Shoulder Movements in Chronic Hemiparetic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Universidade Federal de Sao Carlos
Sponsor class: OTHER
First posted: 2015-03-17
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The stroke is the second cause of death and the first of disabilities in the world. Although a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity present alterations of upper extremity, limiting the performance of daily activities even after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety and efficacy in the treatment of post-stroke individuals still require further investigation. Thus, the objective of this project is to evaluate the immediate effects of ET, applied to the paretic shoulder on proprioception during movements of abduction and flexion of the shoulder and muscle activation and kinematic variables for the reaching in chronic hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET) followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was considered. The motor impairment and the dominance before stroke will be evaluated by Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply deltoid (anterior, middle and posterior). Assessment before and after the application of ET will be performed. For proprioception assessment (joint position sense) will be evaluated using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was calculated. For the assessment of motor performance in a functional task (reach a glass of water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow (total range of motion, joint angle maximum and minimum) will be used. Concomitantly, bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and lower), serratus anterior and pectoral major will be assessed by electromyography during reach. The following electromyographic variables will be analyzed: activation amplitude, muscle onset and maximum and minimum activation. For statistical analysis, the normality and homogeneity tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level for all statistical tests.


Eligibility criteria: Inclusion Criteria:

* Aged between 40 and 70 years and present a minimum score on the Mini Mental State Examination, according to the subject's educational level.
* All subjects must have normal vision or corrected to normal.
* The hemiparetic subjects must present a level of less than 3 spasticity on the Modified Ashworth Scale for shoulder abductor and flexor muscles
* Ability to voluntarily perform the range of motion
* Proper trunk control confirmed by the ability to remain in the seated position without support to the trunk and/or of the arms for 1 minute.

Exclusion Criteria:

* diabetes mellitus
* ulcers or skin lesions
* adverse reactions to tape (redness and itching)
* severe cardiovascular or peripheral vascular diseases (heart failure, arrhythmias, angina pectoris, and acute myocardial infarction)
* other neurological or orthopedic diseases
* cognitive impairments
* presence of sensorimotor peripheral neuropathy
* any history of joint or muscle injuries of the shoulder complex or cervical joints (fractures or surgery)
* shoulder pain during the tests
* presence of any history of joint or muscular injuries of the shoulder complex or cervical joints (fractures or surgery)
* body mass index (BMI) greater than 28 kg/m²
* alterations of sensitivity
* understanding of aphasia
* apraxia
* hemineglect and/or plegia.
* Individuals with other neurologic diseases
* Acute stroke
* Hemorrhagic stroke or any injury to the occipital lobe
* Brainstem or cerebellum injury
* Range of motion of less than 90° flexion or 30° extension and adduction of the shoulder will be excluded.This range of motion is required to standardize the placing of the elastic tape.

Primary outcomes:
measure: Change from Baseline in joint sense position (proprioception) at 10 minutes
timeFrame: baseline and 10 minutes post-application of placebo ou elastic tape
measure: Change from Baseline in joint kinematics of reach at 10 minutes
timeFrame: baseline and 10 minutes post-application of placebo ou elastic tape
measure: Change from Baseline in Electromyography during the reach at 10 minutes
timeFrame: baseline and 10 minutes post-application of placebo ou elastic tape
Secondary outcomes:
Other outcomes:
Locations:
city: São Carlos
country: Brazil
facility: Universidade Federal de São Carlos
state: São Paulo
Study officials:
References:
citation: Jaspers E, Desloovere K, Bruyninckx H, Klingels K, Molenaers G, Aertbelien E, Van Gestel L, Feys H. Three-dimensional upper limb movement characteristics in children with hemiplegic cerebral palsy and typically developing children. Res Dev Disabil. 2011 Nov-Dec;32(6):2283-94. doi: 10.1016/j.ridd.2011.07.038. Epub 2011 Sep 8.
citation: Niessen MH, Veeger DH, Koppe PA, Konijnenbelt MH, van Dieen J, Janssen TW. Proprioception of the shoulder after stroke. Arch Phys Med Rehabil. 2008 Feb;89(2):333-8. doi: 10.1016/j.apmr.2007.08.157.
citation: Carda S, Invernizzi M, Baricich A, Cisari C. Casting, taping or stretching after botulinum toxin type A for spastic equinus foot: a single-blind randomized trial on adult stroke patients. Clin Rehabil. 2011 Dec;25(12):1119-27. doi: 10.1177/0269215511405080. Epub 2011 Jul 5.