Effects of Training in a Virtual Environment in Chronic Stroke Patients

NCT ID: NCT01886183

Last Updated: 2018-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2018-02-28

Brief Summary

The objective of this work will be compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, on the (1) motor function, (2) cognition, (3) balance and (4) gait in chronic stroke patients. It is a prospective, single blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty patients will be randomly assigned in control and experimental group, 20 each one.

Detailed Description

The objective of this work is to compare the effects of two balance training programs, one Nintendo Wii Fit-based and the other traditionally-based without the use of a gaming system, motor function, balance and quality of life in chronic stroke patients. It is a prospective, single-blinded, randomized clinical trial performed at Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University. Forty chronic stroke patients are randomly in control and experimental group, 20 each one. Both groups conduct 14 training sessions, twice a week, for seven weeks. Each session will consist a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups will performed more 30 minutes of balance training: the control group will performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group will performed the balance training with 8 Wii Fit games which stimulate motor and cognitive functions. The main outcome measures will be: (1) the lower limb subscale of the Fugl-Meyer Assessment (FMA-LE); (2); Balance Evaluation Systems Test (BESTest);(3) the Stroke-Specific Quality of Life (SS-QOL); (4) 6- minute walk test (6MWT) and (5) The limits of stability (LOS).

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Virtual Reality Training

The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.

Group Type: EXPERIMENTAL

Virtual Reality Training

Intervention Type: OTHER

The participants of the study will be trained 8 balance games during 14 sessions

Control group: Physical Therapy

The Control Group will be trained by conventional Physical Therapy exercises.

Group Type: ACTIVE_COMPARATOR

Physical Therapy

Intervention Type: OTHER

Patients of the control group will be trained with balance exercises.

Interventions

Virtual Reality Training

The participants of the study will be trained 8 balance games during 14 sessions

Intervention Type: OTHER

Physical Therapy

Patients of the control group will be trained with balance exercises.

Intervention Type: OTHER

Other Intervention Names

Control group

Eligibility Criteria

Inclusion Criteria

• hemiparetic status resulting from a single stroke at least 6 months earlier;
• the ability to walk 10 m independently with or without an assistive device;
• the absence of a musculoskeletal condition that could potentially affect the ability to walk safely;
• the absence of serious visual impairment or a hearing disorder;
• power of at least grade 3 in the hemiplegic lower extremity;
• able to understand and follow simple instructions.

Exclusion Criteria

• a Montreal Cognitive Assessment (MoCA) score of < 20;
• severe dementia or aphasia;
• hemispatial neglect, ataxia or any other cerebellar symptom;
• inability to stand without minimal assist;
• Impaired vision
• Uncontrollable medical complications
• participation in other studies or rehabilitation programs

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Elisa P Piemonte, PT, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Tatiana P Oliveira, PhD student

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Camila S Miranda, Ms Student

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

USPNEC005

Identifier Type: -

Identifier Source: org_study_id