Joint Loose Bodies Clinical Trial
Official title:
EFFECTS OF CONSTRAINT-INDUCED MOVEMENT THERAPY Versus CONVENTIONAL PHYSICAL THERAPY ON FUNCTIONAL RECOVERY AND QUALITY OF LIFE AFTER STROKE
It is estimated that worldwide, about 15 million people are affected by vascular accident (CVA) per year, and in Brazil, the stroke is a major cause of death and disability, generating too much economic and social impact by generating motor sequelae , sensory and cognitive arising from blockage or rupture of blood vessels. Among the motor sequelae is the hemiparesis, which affects about 80% of cases with consequent impairment of the quality of life of individuals. However, physical therapy has shown to facilitate return of the function of these individuals, while minimizing the sensorimotor deficits for promoting neuronal plasticity through the motor relearning. Among the features of physical therapy are the conventional physical therapy techniques, Therapy and Restriction of Movement Induction (TRIM) and the Mental Practice. In view of this, the objective of the study is to compare the application of conventional physiotherapy protocols and TRIM and / or mental practice on the morphometric features, functionality and quality of life of post-stroke hemiparetic subjects in the chronic phase. 60 volunteers will be selected, of both sexes, aged between 45 and 80 years with a clinical diagnosis of stroke, with hemiparesis in the chronic phase were divided into four groups (N = 15): control group (CG), TRIM Group (GT), Mental Practice group (GPM) and group TRIM + Mental Practice (GTPM) to perform specific exercises for each group for three times a week, totaling 24 sessions. Volunteers will be evaluated in four times through the Fugl-Meyer Assessment scale (FMA) adapted and Motor Ability Test of the Upper Limb (THMMS) and to assess the Quality of Life will be used Quality Scale Specific Life Vascular Accident brainstem (EQVE-AVE) and oxidative stress analysis by collecting blood and electromyography for muscular activity. After the research data will be tabulated on an Excel spreadsheet to perform intergroup and intragroup comparisons between the four evaluation times, which will be used for data analysis the BioEstat® 5.2 program, the choice of tests for analysis dependent on the statistical distribution types found and the homogeneity of their variances.
The sample is composed of 60 volunteers of both sexes, with a clinical diagnosis of stroke
(CVA) with injury over six months time that characterizes the chronic stage of the disease
and present hemiparesis in upper limb.
PROCEDURES AND DATA COLLECTION
The research will be divided into the following steps:
STAGE 1: The search will begin with an invitation to volunteers to participate in the study,
through posters and verbal invitation. Then, a pre-selection candidates by applying MMSE will
be performed, Jaeger card and Whisper test in order to evaluate the existence of cognitive
impairment, visual and auditory respectively. If they can make up the sample, volunteers will
be selected as meeting the inclusion and exclusion criteria, and researchers will deliver
two-way the IC explaining how occur the research objectives of the Office and application of
the Protocol and deliver two-way also statement of photographs and footage authorization for
display permit photos and footage. It is noteworthy that both routes of the term and
Declaration will be signed on every page by volunteers, which will be a copy of each document
with the same.
Prior to the procedures and data collection, the researchers will be trained in the
application of all instruments of evaluation and handling of resources to be used in the
treatment of volunteers.
2nd STAGE: Volunteers will be evaluated through the scale application of FMA and THMMS in
order to analyze the functionality and ability of MS and QOL will be assessed by EQVE-stroke
as described in materials in this methodology.
The amplitude of the paretic upper limb movement will also be assessed by goniometry
scapulohumeral humeral joint, shoulder, elbow, wrist, thumb interphalangeal and where use of
a universal manual goniometer and another smaller toward the measuring fingers. The first
measure goniometric be obtained after the patient's arrival in treatment- place in the
pre-treatment. The following measures will be during treatment (12 ° session) and the
immediate and late stages after the treatment. To perform such a procedure will be asked to
volunteers who remain supine on a stretcher, followed by the sitting position in a chair, the
latter should position the upper limb aligned to the trunk and forearm to be evaluated on a
small table, a neutral pronation and supination with the elbow held in 90 ° of flexion.
3rd STAGE: Next muscle electromyographic activity will be measured by electromyography
apparatus of Miotec ®.
Volunteers will conduct the test in a well-lit room with adequate ventilation and environment
without noise, which will be placed in the sitting position with arm supported on fixed
surface and so will surface electrodes connected on the paretic upper limb having as guidance
for positioning electrodes muscular motor points previously located by an electrical
stimulator and coupled with a conductive gel, so as to promote a more stable transitions and
tendon insertions in order to quantitatively analyze the information sent nerve member.
The investigators will be asked to volunteer to perform three isometric contractions for four
seconds each with two intervals between contractions two minutes, and asked each contraction
the patient to reach its maximum strength. The muscles to be analyzed will be the flexors of
fingers flexors wrist flexor ulnar elbow flexors, shoulder flexors and internal rotators of
the shoulder, the answers will be measured and displayed on a computer screen that will be
BIOPAC ® system.
4th STAGE: As for the functional range of the MS paretic will be measured by the functional
reach test, adapted to the sitting position, in which the individual will be sitting without
armrest in the chair for the upper limb, positioned laterally to the wall, with shoulder 15
cm away from this without touching it at any time, with feet parallel in a comfortable
position, keeping the shoulder near the wall flexed to 90 °. A tape measure is fixed parallel
to the floor, positioned at the height of the acromion. The volunteer will then be instructed
to lean forward as much as possible; the displacement to be measured on the tape with three
attempts functional range, then obtaining the average of the three.
5th STEP: Then, for the collection of handgrip strength in paretic MS will be used hydraulic
dynamometer handgrip Jamar® where with volunteers in the sitting position in the bed,
standing with the shoulder in neutral position, elbows and wrist in 90 ° neutral position,
the therapist will support the dynamometer. Volunteers will be instructed to perform three
handgrip maneuvers reaching maximum voluntary contraction with each hand, with one-minute
interval between one operation and another. After the collection will be the simple
arithmetic average entrees the three measures collected.
These procedures in the study will take place in four stages: before the start of treatment
that correspond to the pre-treatment; after the 12th session that correspond to intermediate
treatment; immediately after the 24th session, which will correspond to the immediate
post-treatment; and the total intervention time equal to 24 sessions, which will be
distributed in three weekly sessions held on alternate days (Monday, Wednesday and Friday).
After evaluating the functionality evaluation of oxidative stress. Initially it will be
collected blood with a sterile needle through the lancing on the medial side of the digital
pulp of the fourth finger of the left hand, which will be pre-cleaned with 70% alcohol. The
collection of blood drop will be made with a razor through five light taps of this blade with
the drop microscopy. After this, at room temperature (23 ° C), the blade will be kept in
place protected from contact with the blood of nine minutes for the realization of the
collected blood clotting process. At the end of this period, the morphology of these clots is
microscopically observed under a 40X magnification.
Morphological evaluation of oxidative stress in plasm blood be evaluated according to the
test known as Optical Microscopy for cell analysis in vitro or HLB test, also known under the
designation of Dry layer oxidative test, which will be referred to as microscopic morphology
oxidative stress in plasm (EEW).
The EEW provides indirect information on to oxidative stress, among others, using the
following grading system the percentage of the discontinuous area of clot present in
microscope slide: grade I (normal oxidative stress rate, with total area of discontinuous
extracellular matrix (ME) less than 10%), grade II (mild stress, with ME discontinuity area
between 10 to 20%), grade III (moderate stress with ME discontinuity the area between 20
30%), grade IV (severe stress, with ME discontinuity area between 30 to 40%) and the grade V
(very severe stress, with the ME discontinuity area above 40%).
The respective assigned qualitative graduation will be logged into a spreadsheet for further
analysis statistics. As a measure of standardization, the observation of morphological
patterns of different clots will be performed by one of the researchers associated with
assessment by OxyScanner the so-called program developed and marketed by Aldea Global
Soluciones® (SFA), which give a copy of the software.
This evaluation will be done in four stages, which will use throughout the process coats,
disposable gloves and masks, and will be held by only one of the researchers, in order to
avoid bias in the research.
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