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Effects of Training in a Virtual Environment in Chronic Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Virtual Reality Training
Physical Therapy
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Postural Balance, Virtual Reality Exposure Therapy, Gait, Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Reality Training

Control group: Physical Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
FMA-LE is a subscale measuring lower limb motor recovery. It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance

Secondary Outcome Measures

Balance Evaluation Systems Test (BESTest)
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
6-minute walk test
The 6MWT is a practical simple test. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). The 6MWT has been used as a measure of functional status of patients.
Stroke specific quality of life scale
Stroke Specific Quality of Life Scale is a self-report assessment that includes 12 stroke specific subscales with 49 items. The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke specific QOL that are insufficiently assessed with generic QOL measures. The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity. Participants responded to each item on a 5-point scale. Domain scores are the averages of the item scores, and the total score is the average of the domain scores. All summary scores therefore range from 1 to 5. Higher scores indicate better function.
Limits of Stability
The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets. Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject. As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible. The parameters include COP movement velocity and directional control (% to target).

Full Information

First Posted
June 20, 2013
Last Updated
November 1, 2018
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01886183
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
February 2014 (Actual)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Postural Balance, Virtual Reality Exposure Therapy, Gait, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality Training
Arm Type
Experimental
Arm Description
The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit.
Arm Title
Control group: Physical Therapy
Arm Type
Active Comparator
Arm Description
The Control Group will be trained by conventional Physical Therapy exercises.
Intervention Type
Other
Intervention Name(s)
Virtual Reality Training
Intervention Description
The participants of the study will be trained 8 balance games during 14 sessions
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Other Intervention Name(s)
Control group
Intervention Description
Patients of the control group will be trained with balance exercises.
Primary Outcome Measure Information:
Title
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Description
FMA-LE is a subscale measuring lower limb motor recovery. It examines movement and coordination of the hip, knee, and ankle in the supine, sitting, and standing positions. Each item is scored on a 3-point scale (0, cannot perform; 1, partially performs; 2, performs fully). The score range is 0 to 34, with higher scores indicating better lower limb motor performance
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Balance Evaluation Systems Test (BESTest)
Description
Balance Evaluation Systems Test (BESTest) measures balance. It includes 36 items that evaluate performance of 6 balance systems: biomechanical constraints, stability limits/verticality, anticipatory postural adjustments, postural responses, sensory orientation, and stability in gait.
Time Frame
Up 2 months
Title
6-minute walk test
Description
The 6MWT is a practical simple test. This test measures the distance that a patient can quickly walk on a flat, hard surface in a period of 6 minutes (the 6MWD). The 6MWT has been used as a measure of functional status of patients.
Time Frame
Up to 2 months
Title
Stroke specific quality of life scale
Description
Stroke Specific Quality of Life Scale is a self-report assessment that includes 12 stroke specific subscales with 49 items. The Stroke Specific Quality of Life Scale attempts to capture the domains of stroke specific QOL that are insufficiently assessed with generic QOL measures. The 12 subscales, which are unidimensional, are Energy, Family Role, Language, Mobility, Mood, Personality, Self-Care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work-Productivity. Participants responded to each item on a 5-point scale. Domain scores are the averages of the item scores, and the total score is the average of the domain scores. All summary scores therefore range from 1 to 5. Higher scores indicate better function.
Time Frame
Up to 2 months
Title
Limits of Stability
Description
The Limits of Stability subtest quantifies the maximum distance a person can intentionally displace their center of pressure (COP) from start position of midline COP centered over the base of support to eight targets. Location and movement of the COP was indicated by a cursor display projected on a screen in front of the subject. As targets were highlighted, the subject was to move the COP cursor quickly and accurately as possible towards a target located on the Limits of Stability perimeter and hold position as close to the target as possible. The parameters include COP movement velocity and directional control (% to target).
Time Frame
Up to 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisa P Piemonte, PT, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tatiana P Oliveira, PhD student
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Camila S Miranda, Ms Student
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-160
Country
Brazil

12. IPD Sharing Statement

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Effects of Training in a Virtual Environment in Chronic Stroke Patients

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