Overview

This trial is active, not recruiting.

Condition stroke
Treatment elastic tape application in shoulder
Sponsor Universidade Federal de Sao Carlos
Start date March 2015
End date July 2016
Trial size 40 participants
Trial identifier NCT02390115, 966.636

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Active Comparator)
Tape placing will consider as the initial anchor the acromioclavicular joint, and as the final one the point immediately below the insertion of the deltoid muscle. Two centimeters anchor will be considered for all the participants, and the active zone will be equivalent to the distance between two anchors. The first tape will be placed to the anterior portion of the deltoid with the shoulder at 30° passive extension. The second tape will be placed to the middle portion of the deltoid with the shoulder at 30° of passive horizontal adduction. For placing the third tape to the posterior deltoid, the limb will be positioned at 90° of passive flexion of the shoulder. The elastic tape tension will be placed as previously described as "paper tension" and it is equivalent to 10-15% of the total elastic tape tension.
elastic tape application in shoulder
(Sham Comparator)
The sham elastic tape will be placed using the same tape to the paretic shoulder. However, the rigid tape will be placed without tension with the upper limb supporting at 90 degree elbow flexion, 0 degrees abduction and adduction of the shoulder.
elastic tape application in shoulder

Primary Outcomes

Measure
Change from Baseline in joint sense position (proprioception) at 10 minutes
time frame: baseline and 10 minutes post-application of placebo ou elastic tape
Change from Baseline in joint kinematics of reach at 10 minutes
time frame: baseline and 10 minutes post-application of placebo ou elastic tape
Change from Baseline in Electromyography during the reach at 10 minutes
time frame: baseline and 10 minutes post-application of placebo ou elastic tape

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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.

Additional Information

Official title Effects of Elastic Tape in Proprioception and Performance of Shoulder Movements in Chronic Hemiparetic Subjects
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Universidade Federal de Sao Carlos.