StrokeNCT02475083
Use of Virtual Reality Games for the Treatment of Balance and Reducing the Occurrence of Falls in Patients After Stroke
A study testing Virtual Reality and Conventional in people with Stroke, run by Pedreira, Érika, M.D..
Trial summary
The aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke. 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 and Conventional
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Dec 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients of both sexes with hemiparesis after stroke of 18 to 65 years.
Who cannot join
- less than 6 months of injury with sensory or perceptual deficit.
About this study
Official title: Therapeutic Effect of Virtual Reality in Patients After Stroke
The aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.
Read the detailed description
Randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke of 18 to 65 years. They excluded those who had less than six months of injury, with sensory or perceptual deficit. Patients included were randomized into two groups, a treatment group, which conducted rehabilitation with virtual reality associated with conventional physical therapy and the control group that performed only conventional physiotherapy. Randomization was done by a computer program in blocks, by a third person, respecting the allocation concealment. After selection and randomization, patients were evaluated at baseline, when they were collected demographic and clinical data, investigated the occurrence of falls in the three months prior to evaluation and rated the balance in motion using the Dynamic Gait Index (DGI). Patients were followed for 20 physiotherapy sessions, visits twice a week for an hour each. The assessment of the balance and the investigation of the occurrence of falls were repeated at the end of treatment, which occurred on average three months after the start of the intervention, by the same examiner, who remained blind to the group that the patient belonged.
- Conditions
- Stroke
- Being tested
- Virtual Reality, Conventional
- Keywords
- Stroke, Virtual reality, Balance, Falls
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityOther
Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.
ConventionalOther
Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Group | Experimental | Rehabilitation with virtual reality using games with balance training goal. Receives: Other: Virtual Reality; Other: Conventional |
| Conventional Group | Active comparator | Conventional physiotherapy with exercises for balance training. Receives: Other: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Gait Index (DGI)
Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
Measured: avarage 8 weeks
Secondary outcomes (1)
Number of Falls
falls in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
Measured: avarage 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
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.
- 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
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pedreira, Érika, M.D.
- Responsible party
- Principal investigator, Érika Pedreira, Pedreira, Érika, M.D.
- Investigators
- Erika Fonseca, Principal investigator, Pedreira, Érika, M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475083
- Sponsor's protocol ID
- EP-13-RV
- Status last verified
- Aug 2014
- First submitted
- 12 Jun 2015
- Last updated
- 18 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Virtual Reality in Patients After Stroke
- ClinicalTrials.gov ID
- NCT02475083
- Acronym / sponsor ID
- EP-13-RV
- Conditions
- Stroke
- Keywords
- Stroke, Virtual reality, Balance, Falls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Pedreira, Érika, M.D.
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 18 Jun 2015 (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 aim of this study was to investigate the therapeutic effect of virtual reality associated with conventional physiotherapy on balance during gait and the occurrence of falls in patients after stroke.
Detailed description
Randomized clinical trial conducted with patients of both sexes with hemiparesis after stroke of 18 to 65 years. They excluded those who had less than six months of injury, with sensory or perceptual deficit. Patients included were randomized into two groups, a treatment group, which conducted rehabilitation with virtual reality associated with conventional physical therapy and the control group that performed only conventional physiotherapy. Randomization was done by a computer program in blocks, by a third person, respecting the allocation concealment. After selection and randomization, patients were evaluated at baseline, when they were collected demographic and clinical data, investigated the occurrence of falls in the three months prior to evaluation and rated the balance in motion using the Dynamic Gait Index (DGI). Patients were followed for 20 physiotherapy sessions, visits twice a week for an hour each. The assessment of the balance and the investigation of the occurrence of falls were repeated at the end of treatment, which occurred on average three months after the start of the intervention, by the same examiner, who remained blind to the group that the patient belonged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Group | Experimental | Other: Virtual Reality, Other: ConventionalRehabilitation with virtual reality using games with balance training goal. |
| Conventional Group | Active comparator | Other: ConventionalConventional physiotherapy with exercises for balance training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients of both sexes with hemiparesis after stroke of 18 to 65 years.
Key exclusion criteria (1 listed)
- less than 6 months of injury with sensory or perceptual deficit.
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 RealityRehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis. | Other | Virtual Reality Group |
| ConventionalStretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training. | Other | Conventional Group, Virtual Reality Group |
Primary outcome
Dynamic Gait Index (DGI)
Time frame: avarage 8 weeks
Balance during gait in patients after stroke undergoing rehabilitation with virtual reality associated with conventional physiotherapy.
1 secondary outcome
Number of Falls
Time frame: avarage 8 weeks
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 18 Jun 2015.
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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.
Erika Fonseca principal investigator
Pedreira, Érika, M.D.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality and Conventional in people with Stroke, run by Pedreira, Érika, M.D..
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 1 inclusion and 1 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 18 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Dynamic Gait Index (DGI) (time frame: avarage 8 weeks). 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 18 Jun 2015.