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Virtual Therapy in Rehabilitation Spastic Hemiparesis

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
virtual therapy
conventional physiotherapy
Sponsored by
Universidade do Vale do Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, spasticity, physiotherapy, virtual reality

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Medical referral for physiotherapy;
  • Maximum grade 2 spasticity in the upper and lower limbs according to the Modified Ashworth Scale;
  • Total passive range of elbow joint and knee to the movement of flexion and extension;
  • Independent ambulation, with or without support;
  • Cognitive preserved, being able to respond to the command of the examiner;
  • Least 6 months of injury;

Exclusion Criteria:

  • Active infection, and rash at the site of application of NMES;
  • Visual and hearing impairment;
  • Joint stiffness and musculoskeletal injuries of the elbow and knee,
  • Inability to interpret the therapeutic resources to be displayed;
  • Presenting lesions in areas of Wernick and drill;
  • Uncontrolled hypertension.

Sites / Locations

  • Lersm, Ip&DRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

virtual therapy

conventional physiotherapy

Arm Description

Group 1 (G1) included 20 patients who will carry out the virtual therapy.

Group 2 (G2) included 20 patients who hold conventional physiotherapy.

Outcomes

Primary Outcome Measures

Espasticity
It is believed that this study achieves positive results regarding the adequacy of muscle tone associated with musculoskeletal better performance, so that the muscles normotônicos gain strength and overcome the resistance of the hypertonic muscles, improving range of motion and harmony of the affected limbs, leading the consequent improvement of balance and gait, after application of virtual therapy.

Secondary Outcome Measures

Full Information

First Posted
February 7, 2014
Last Updated
February 10, 2014
Sponsor
Universidade do Vale do Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT02061371
Brief Title
Virtual Therapy in Rehabilitation Spastic Hemiparesis
Official Title
VIRTUAL THERAPY IN REHABILITATION SPASTIC HEMIPARESIS
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Vale do Paraíba

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.
Detailed Description
Considered the second most frequent cause of death worldwide , the stroke is also responsible for the largest number of functional disability in individuals. The socio - economic hardship that many patients face to perform a program of intensive rehabilitation sensorimotor, has led to functional limitations in many cases , promote irreversible consequences. Spasticity in the upper and lower limb after stroke results in loss of function and mobility being the key therapeutic approaches in order to restore its function. Currently, the Virtual therapy has been used in physical therapy, demonstrating safety, feasibility and potential to facilitate the effective rehabilitation treatment, promoting motor recovery. The objective of this study is to analyze and compare the effectiveness of virtual therapy and conventional physiotherapy in paretic upper and lower limbs of patients with sensory motor deficit after stroke. Virtual therapy will be based on a custom application using virtual reality projection, and conventional treatment will be based on cinesiotherapy for members upper and lower paretic. The evaluation will be performed by biomedical instrumentation using dynamometry, electromyography and analysis from functional movement. Statistical differences are based on t test with significance level of p 0 , 05 . As a result expected - scientifically proven the effectiveness of this new form of treatment aimed at improving quality of life and functional independence of patients with neurological sequel.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, spasticity, physiotherapy, virtual reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
virtual therapy
Arm Type
Experimental
Arm Description
Group 1 (G1) included 20 patients who will carry out the virtual therapy.
Arm Title
conventional physiotherapy
Arm Type
Experimental
Arm Description
Group 2 (G2) included 20 patients who hold conventional physiotherapy.
Intervention Type
Other
Intervention Name(s)
virtual therapy
Intervention Type
Other
Intervention Name(s)
conventional physiotherapy
Primary Outcome Measure Information:
Title
Espasticity
Description
It is believed that this study achieves positive results regarding the adequacy of muscle tone associated with musculoskeletal better performance, so that the muscles normotônicos gain strength and overcome the resistance of the hypertonic muscles, improving range of motion and harmony of the affected limbs, leading the consequent improvement of balance and gait, after application of virtual therapy.
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medical referral for physiotherapy; Maximum grade 2 spasticity in the upper and lower limbs according to the Modified Ashworth Scale; Total passive range of elbow joint and knee to the movement of flexion and extension; Independent ambulation, with or without support; Cognitive preserved, being able to respond to the command of the examiner; Least 6 months of injury; Exclusion Criteria: Active infection, and rash at the site of application of NMES; Visual and hearing impairment; Joint stiffness and musculoskeletal injuries of the elbow and knee, Inability to interpret the therapeutic resources to be displayed; Presenting lesions in areas of Wernick and drill; Uncontrolled hypertension.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Carolina Borges, masters students
Phone
5512981014448
Email
carolborges.fisio@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mário Oliveira Lima, professor
Phone
551239471000
Ext
2066
Email
mol@univap.br
Facility Information:
Facility Name
Lersm, Ip&D
City
São José dos Campos
State/Province
São Paulo
ZIP/Postal Code
12244-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Carolina Borges, masters students
Phone
5512981014448
Email
carolborges.fisio@gmail.com

12. IPD Sharing Statement

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Virtual Therapy in Rehabilitation Spastic Hemiparesis

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