NCT02932631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 30, 2018

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

September 6, 2016

Last Update Submit

January 29, 2018

Conditions

Keywords

hemiparesisSTROKEneural plasticityPHYSICAL THERAPY

Outcome Measures

Primary Outcomes (3)

  • electromyography

    For the evaluation of electrical muscle activity through electromyography through surface electrodes analyzed musculatures flexors and wrist extensors and elbow (median frequency, raw).

    pre-treatment and after 8 weeks

  • motor skills in the upper limbs

    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.

    pre-treatment and after 8 weeks

  • quality of life

    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.

    pre-treatment and after 8 weeks

Study Arms (2)

CONVENTIONAL PHYSICAL THERAPY group

ACTIVE COMPARATOR

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

containment therapy induced

EXPERIMENTAL

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

Interventions

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.

Also known as: PRACTICING MENTAL THERAPY, CONVENTIONAL PHYSICAL THERAPY
CONVENTIONAL PHYSICAL THERAPY groupcontainment therapy induced

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Metodista de Piracicaba

Piracicaba, São Paulo, Brazil

Location

Related Publications (2)

  • Liepert J, Uhde I, Graf S, Leidner O, Weiller C. Motor cortex plasticity during forced-use therapy in stroke patients: a preliminary study. J Neurol. 2001 Apr;248(4):315-21. doi: 10.1007/s004150170207.

  • Jackson PL, Lafleur MF, Malouin F, Richards C, Doyon J. Potential role of mental practice using motor imagery in neurologic rehabilitation. Arch Phys Med Rehabil. 2001 Aug;82(8):1133-41. doi: 10.1053/apmr.2001.24286.

MeSH Terms

Conditions

Joint Loose BodiesParesisStroke

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

September 6, 2016

First Posted

October 13, 2016

Study Start

August 1, 2015

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

January 30, 2018

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations