Virtual Therapy in Rehabilitation Spastic Hemiparesis

Stroke Clinical Trial

Official title:

VIRTUAL THERAPY IN REHABILITATION SPASTIC HEMIPARESIS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02061371
• Other study ID #: 20749113.5.0000.5503
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2014
• Last updated: February 10, 2014
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2014
• Source: Universidade do Vale do Paraíba
• Contact: Ana Carolina Borges, masters students
• Phone: 5512981014448
• Email: carolborges.fisio[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Other:
• virtual therapy

• conventional physiotherapy

Locations

Country	Name	City	State
Brazil	Lersm, Ip&D	São José dos Campos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Vale do Paraíba

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No