ElderlyNCT01741402
Effects of Training in a Virtual Environment in Healthy Elderly
A study testing Virtual Reality Training and Physical Therapy in people with Elderly, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The objective of this work was 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, on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- Virtual Reality Training and Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2010to Feb 2014
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 60 to 85 years.
- Absence of other neurological disorders or co-morbidities that may affect gait;
- Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
- Absence of depression (score above 5 on the Geriatric Depression Scale of Yesaváge - version 15);
- Score on the Berg Balance Scale above 41;
- Vision and hearing adequate or corrected to normal;
- Ability to walk independently;
Who cannot join
- Biomechanical alterations (other pathologies) that could compromise the completion of training;
- Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during balance and gait training;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Center of Research of the courses of Speech Therapy, Physical Therapy and Occupational Therapy of São Paulo University
São Paulo, São Paulo, 05360-000
About this study
Official title: Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly
The objective of this work was 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, on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. 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. Thirty-two older adults are randomly in control and experimental group, 16 each one. The study includes only participants scoring at least 24 in the Mini-Mental State Examination to rule out effects of dementia; without the presence of depression, according to the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg Balance Scale (EBB ≥ 41).
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, on balance, gait, functionality and cognition ability in older adults. 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. Thirty-two older adults are randomly in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session is composed of a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures are: (1) Mini-BESTest of Dynamic Balance Evaluation; (2) Dynamic Gait Index (DGI); (3) Montreal Cognitive Assessment (MoCA); and (4) Falls Efficacy Scale - International (FES-I).
- Conditions
- Elderly
- Being tested
- Virtual Reality Training, Physical Therapy
- Keywords
- Control posture, Gait, Virtual Reality, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality TrainingDevice
The participants of the study trained 10 balance games during 14 sessions
Physical TherapyOther
Patients of the control group was trained with balance exercises.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Training | Experimental | The virtual reality training was done by experimental group with ten games of Nintendo Wii Fit. Receives: Device: Virtual Reality Training |
| Physical Therapy | Active comparator | The Control Group was 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.
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test
The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation and dynamic gait.
Measured: Up to 3 months
Secondary outcomes (3)
Dynamic Gait Index
The scale assesses the ability to adapt the gait during motor tasks with different demands.
Measured: Up to 3 months
Montreal Cognitive Assessment
This scale was developed in order to detect mild degrees of cognitive impairment. The instrument assesses different cognitive domains such as attention and concentration, executive functions, memory, language, visuo-constructive skills, calculations, and orientation.
Measured: Up to 3 months
Falls Efficacy Scale - International
The Falls Efficacy Scale-International (FES-I)measures the level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study startFeb 2010
- Primary completionJan 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Responsible party
- Sponsor
- Investigators
- Maria Elisa P Piemonte, PhD, Study director, University of Sao PauloKeyte Guedes, MS Student, Principal investigator, University of Sao PauloAlexandra M Lobo, MS Student, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741402
- Sponsor's protocol ID
- USPNEC004
- Status last verified
- Nov 2012
- First submitted
- 30 Nov 2012
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training in a Virtual Environment on the Performance of Gait, Postural Control and Executive Functions in Healthy Elderly
- ClinicalTrials.gov ID
- NCT01741402
- Acronym / sponsor ID
- USPNEC004
- Conditions
- Elderly
- Keywords
- Control posture, Gait, Virtual Reality, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Coordination for the Improvement of Higher Education Personnel
- Study start
- Feb 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 4 Dec 2012 (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 was 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, on the (1) balance, (2) gait, (3) functionality and (4) cognition ability in older adults. 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. Thirty-two older adults are randomly in control and experimental group, 16 each one. The study includes only participants scoring at least 24 in the Mini-Mental State Examination to rule out effects of dementia; without the presence of depression, according to the Geriatric Depression Scale of Yesaváge - version 15 (GDS-15 ≤ 5) and scores on the Berg Balance Scale (EBB ≥ 41).
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, on balance, gait, functionality and cognition ability in older adults. 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. Thirty-two older adults are randomly in control and experimental group, 16 each one. Both groups performed 14 training sessions, twice a week, for seven weeks. Each session is composed of a 30 minute-global-exercise series including stretching, muscle strength and axial mobility exercises. After this, both groups performed more 30 minutes of balance training: the control group performed balance exercises without external cues, visual or auditory feedbacks or cognitive stimulations; the experimental group performed the balance training with 10 Wii Fit games which stimulated motor and cognitive functions. The main outcome measures are: (1) Mini-BESTest of Dynamic Balance Evaluation; (2) Dynamic Gait Index (DGI); (3) Montreal Cognitive Assessment (MoCA); and (4) Falls Efficacy Scale - International (FES-I).
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 | Device: Virtual Reality TrainingThe virtual reality training was done by experimental group with ten games of Nintendo Wii Fit. |
| Physical Therapy | Active comparator | Other: Physical TherapyThe Control Group was trained by conventional Physical Therapy exercises. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 60 to 85 years.
- Absence of other neurological disorders or co-morbidities that may affect gait;
- Absence of dementia (score above 24 on the Mini Mental State Examination - MMSE);
- Absence of depression (score above 5 on the Geriatric Depression Scale of Yesaváge - version 15);
- Score on the Berg Balance Scale above 41;
Key exclusion criteria (2 listed)
- Biomechanical alterations (other pathologies) that could compromise the completion of training;
- Presence of any neurological, auditory or visual deficit that could compromise distracting task performance during balance and gait training;
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 trained 10 balance games during 14 sessions | Device | Virtual Reality Training |
| Physical TherapyPatients of the control group was trained with balance exercises. | Other | Physical Therapy |
Primary outcome
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test
Time frame: Up to 3 months
The Mini-BESTest test is a 14-item test that focuses on dynamic balance, specifically anticipatory transitions, postural responses, sensory orientation and dynamic gait.
3 secondary outcomes
Dynamic Gait Index
Time frame: Up to 3 months
Montreal Cognitive Assessment
Time frame: Up to 3 months
Falls Efficacy Scale - International
Time frame: Up to 3 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 12 Apr 2017.
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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, PhD study director
University of Sao Paulo
Keyte Guedes, MS Student principal investigator
University of Sao Paulo
Alexandra M Lobo, 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 Elderly, 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 7 inclusion and 2 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 12 Apr 2017. 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?
Mini-BESTest of Dynamic Balance Evaluation - Balance Evaluation Systems Test (time frame: Up to 3 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 12 Apr 2017.