Clinical trial NCT01886183: Effects of Training in a Virtual Environment in Chronic Stroke Patients
Official title: Effects of Training in a Virtual Environment on the Motor Function,Postural Control and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Postural Balance
Virtual Reality Exposure Therapy
Gait
Stroke
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-06-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
timeFrame: up to 2 months
Secondary outcomes:
measure: Balance Evaluation Systems Test (BESTest)
timeFrame: Up 2 months
measure: 6-minute walk test
timeFrame: Up to 2 months
measure: Stroke speciﬁc quality of life scale
timeFrame: Up to 2 months
measure: Limits of Stability
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Maria Elisa P Piemonte, PT, PhD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Tatiana P Oliveira, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Camila S Miranda, Ms Student
role: PRINCIPAL_INVESTIGATOR
References: