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Virtual Therapy in Rehabilitation Spastic Hemiparesis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02061371
Recruitment Status : Unknown
Verified January 2014 by Universidade do Vale do Paraíba.
Recruitment status was:  Recruiting
First Posted : February 12, 2014
Last Update Posted : February 12, 2014
Information provided by (Responsible Party):
Universidade do Vale do Paraíba

Brief Summary:
Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.

Condition or disease Intervention/treatment Phase
Stroke Other: virtual therapy Other: conventional physiotherapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2013
Actual Primary Completion Date : February 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: virtual therapy
Group 1 (G1) included 20 patients who will carry out the virtual therapy.
Other: virtual therapy
Experimental: conventional physiotherapy
Group 2 (G2) included 20 patients who hold conventional physiotherapy.
Other: conventional physiotherapy

Primary Outcome Measures :
  1. Espasticity [ Time Frame: 4 months ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT02061371

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Contact: Ana Carolina Borges, masters students 5512981014448
Contact: Mário Oliveira Lima, professor 551239471000 ext 2066

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Lersm, Ip&D Recruiting
São José dos Campos, São Paulo, Brazil, 12244-000
Contact: Ana Carolina Borges, masters students    5512981014448   
Sponsors and Collaborators
Universidade do Vale do Paraíba
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Responsible Party: Universidade do Vale do Paraíba Identifier: NCT02061371    
Other Study ID Numbers: 20749113.5.0000.5503
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: February 12, 2014
Last Verified: January 2014
Keywords provided by Universidade do Vale do Paraíba:
virtual reality
Additional relevant MeSH terms:
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Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms