StrokeNCT01886183
Effects of Training in a Virtual Environment in Chronic Stroke Patients
A study testing Virtual Reality Training and Physical Therapy in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Virtual Reality Training and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physiotherapy, Communication Science & Disorders, Occupational Therapy, School of Medicine, University of São Paulo
São Paulo, 05360-160
About this study
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
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.
Read the 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
- Being tested
- Virtual Reality Training, Physical Therapy
- Keywords
- Postural Balance, Virtual Reality Exposure Therapy, Gait, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TrainingOther
The participants of the study will be trained 8 balance games during 14 sessions
Physical TherapyOther
Also called Control group
Patients of the control group will be trained with balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training | Experimental | The virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit. Receives: Other: Virtual Reality Training |
| Control group: Physical Therapy | Active comparator | The Control Group will be trained by conventional Physical Therapy exercises. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 months
Secondary outcomes (4)
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.
Measured: Up 2 months
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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).
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Elisa P Piemonte, PT, PhD, Study director, University of Sao PauloTatiana P Oliveira, PhD student, Principal investigator, University of Sao PauloCamila S Miranda, Ms Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886183
- Sponsor's protocol ID
- USPNEC005
- Status last verified
- Jul 2018
- First submitted
- 20 Jun 2013
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01886183
- Acronym / sponsor ID
- USPNEC005
- Conditions
- Stroke
- Keywords
- Postural Balance, Virtual Reality Exposure Therapy, Gait, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Training | Experimental | Other: Virtual Reality TrainingThe virtual reality training will be done by experimental group with ten games of Nintendo Wii Fit. |
| Control group: Physical Therapy | Active comparator | Other: Physical TherapyThe Control Group will be trained by conventional Physical Therapy exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality TrainingThe participants of the study will be trained 8 balance games during 14 sessions | Other | Virtual Reality Training |
| Physical TherapyAlso: Control groupPatients of the control group will be trained with balance exercises. | Other | Control group: Physical Therapy |
Primary outcome
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE)
Time frame: up to 2 months
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
4 secondary outcomes
Balance Evaluation Systems Test (BESTest)
Time frame: Up 2 months
6-minute walk test
Time frame: Up to 2 months
Stroke specific quality of life scale
Time frame: Up to 2 months
Limits of Stability
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elisa P Piemonte, PT, PhD study director
University of Sao Paulo
Tatiana P Oliveira, PhD student principal investigator
University of Sao Paulo
Camila S Miranda, Ms Student principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Training and Physical Therapy in people with Stroke, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The lower limb subscale of the Fugl-Meyer Assessment (FMA-LE) (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.