Virtual Therapy in Rehabilitation Spastic Hemiparesis

VIRTUAL THERAPY IN REHABILITATION SPASTIC HEMIPARESIS

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

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Other: virtual therapy; Other: conventional physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Carolina Borges, masters students; Phone Number: 5512981014448; Email: carolborges.fisio@gmail.com
• Study Contact Backup: Name: Mário Oliveira Lima, professor; Phone Number: 2066 551239471000; Email: mol@univap.br

Study Locations

• Brazil
  • São Paulo
    • São José dos Campos, São Paulo, Brazil, 12244-000
      • Recruiting
      • Lersm, Ip&D
      • Contact: Ana Carolina Borges, masters students; Phone Number: 5512981014448; Email: carolborges.fisio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 months

Collaborators and Investigators

• Sponsor: Universidade do Vale do Paraíba

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 7, 2014
• First Submitted That Met QC Criteria: February 10, 2014
• First Posted (Estimate): February 12, 2014

Study Record Updates

• Last Update Posted (Estimate): February 12, 2014
• Last Update Submitted That Met QC Criteria: February 10, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: stroke; physiotherapy; spasticity; virtual reality
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 20749113.5.0000.5503

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No