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Different Methods of Physical Therapy for Stroke

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ClinicalTrials.gov Identifier: NCT02932631
Recruitment Status : Completed
First Posted : October 13, 2016
Last Update Posted : January 30, 2018
Sponsor:
Information provided by (Responsible Party):
Larissa Salgado de Oliveira Rocha, Universidade Metodista de Piracicaba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Joint Loose Bodies Other: THERAPY CONTROL AND MOVEMENT OF INDUCTION Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: EFFECTS OF CONSTRAINT-INDUCED MOVEMENT THERAPY Versus CONVENTIONAL PHYSICAL THERAPY ON FUNCTIONAL RECOVERY AND QUALITY OF LIFE AFTER STROKE
Actual Study Start Date : August 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: CONVENTIONAL PHYSICAL THERAPY group

physical exercises divided into three phases:

  1. stretching, strengthening and/or mobilization;
  2. functional training of the affected muscles;
  3. functional training of the paretic limb.
Other: THERAPY CONTROL AND MOVEMENT OF INDUCTION

Volunteers conventional physiotherapy group will stretching, strengthening and / or mobilization and functional training of the affected muscles with 3 sets of 10 repetitions for 60 minutes.

The restriction therapy group and induction motion the volunteers will wear a brace on the top healthy member to be restricted in each session during the exercises for this group for a period of 60 minutes, encouraging tasks involving activities of daily living and / or daily. In group practice mental, the volunteers listen to a CD that in the first two minutes, will promote progressive relaxation where imaginary in a calm and quiet place followed by 13 minutes of listening to the restriction therapy exercise protocol and motion induction. The association group practices and mental restriction therapy, volunteer listens to the CD for 15 minutes following the same procedures mentioned in group practice mental, followed by exercises functional activities for 45 minutes in the paretic limb.

Other Names:
  • PRACTICING MENTAL THERAPY
  • CONVENTIONAL PHYSICAL THERAPY

Experimental: containment therapy induced
healthy side is restricted with splinting and exercises in hemiparetic member: carry out functional tasks individually. Each task will be held for 5 minutes, totaling 60 minutes of service
Other: THERAPY CONTROL AND MOVEMENT OF INDUCTION

Volunteers conventional physiotherapy group will stretching, strengthening and / or mobilization and functional training of the affected muscles with 3 sets of 10 repetitions for 60 minutes.

The restriction therapy group and induction motion the volunteers will wear a brace on the top healthy member to be restricted in each session during the exercises for this group for a period of 60 minutes, encouraging tasks involving activities of daily living and / or daily. In group practice mental, the volunteers listen to a CD that in the first two minutes, will promote progressive relaxation where imaginary in a calm and quiet place followed by 13 minutes of listening to the restriction therapy exercise protocol and motion induction. The association group practices and mental restriction therapy, volunteer listens to the CD for 15 minutes following the same procedures mentioned in group practice mental, followed by exercises functional activities for 45 minutes in the paretic limb.

Other Names:
  • PRACTICING MENTAL THERAPY
  • CONVENTIONAL PHYSICAL THERAPY




Primary Outcome Measures :
  1. electromyography [ Time Frame: pre-treatment and after 8 weeks ]
    For the evaluation of electrical muscle activity through electromyography through surface electrodes analyzed musculatures flexors and wrist extensors and elbow (median frequency, raw).

  2. motor skills in the upper limbs [ Time Frame: pre-treatment and after 8 weeks ]
    For evaluating the functionality of the Fugl-Meyer Assessment Scale was developed with the objective of evaluating six aspects of the patient, range of motion and pain, motor function, sensitivity, balance, coordination and speed. But the Motor Ability Test of the Upper Limb (THMMS) to measure quantitative and qualitative aspects of ADLs involving the upper limb in patients who have suffered strokes.Scales do not have measurement units only get a total points.

  3. quality of life [ Time Frame: pre-treatment and after 8 weeks ]
    Quality of Life Scale for Stroke (EQVE-AVE) which consists of 49 items, divided into 12 areas divided into energy, family role, language, mobility, humor, For the assessment of quality of life will be used Specific personality, self-care, social role, reasoning, upper limb function (MS), vision and work / productivity. Will be evaluated pre-treatment and after 24 sessions.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • will be included in the study volunteers with stroke diagnosis for six months or more lesions.
  • showing hemiparesis
  • with at least 20 of passive extension handle and 10 for the fingers (TREVISAN; TRINTINAGLIA, 2010)
  • who are aged between 45 and 80 years
  • independent of race, color and cultural socioeconomic status, that are experiencing higher score to 24 points on the MMSE, which are not performing physical therapy at the time of the study and who agree and sign the consent form.

Exclusion Criteria:

  • volunteers with a diagnosis of stroke at least six months
  • stroke recurrence
  • double hemiparesis
  • hemiplegia, which present associated diseases
  • uncontrolled hypertension according to the Brazilian Guidelines on Hypertension (systolic blood pressure (BP)> 90 and <140 diastolic pressure (DP )> 50 and <90) and heart rate (HR) 80-100 bpm
  • respiratory rate (RR) from 18 to 20 rpm, with 36 temperature, diabetes, heart disease, apraxia, aphasia, that are experiencing pain and deformities upper limb, that are experiencing cognitive impairment, visual and hearing impairment, which will be assessed using the Mini Mental State Examination -MEEM tests (Appendix a) with scores below 24 points or taking into account score for illiterates, Jaeger Card (ANNEX B) and Test Whisper (ANNEX C) respectively
  • who performs physical therapy at the time of the study, who do not agree and refuse to sign the Informed Consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02932631


Locations
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Brazil
Universidade Metodista de Piracicaba
Piracicaba, São Paulo, Brazil
Sponsors and Collaborators
Universidade Metodista de Piracicaba

Publications of Results:
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Responsible Party: Larissa Salgado de Oliveira Rocha, researcher, Universidade Metodista de Piracicaba
ClinicalTrials.gov Identifier: NCT02932631     History of Changes
Other Study ID Numbers: 41597715.9.0000.5174
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: January 30, 2018
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larissa Salgado de Oliveira Rocha, Universidade Metodista de Piracicaba:
hemiparesis
STROKE
neural plasticity
PHYSICAL THERAPY

Additional relevant MeSH terms:
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Joint Loose Bodies
Joint Diseases
Musculoskeletal Diseases