ElderlyVR-FallersNCT01182961
The Use of Virtual Reality for the Gait Training of Elderly Fallers
A study testing gait training, gait training 2 and exercise group in people with Elderly, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly… Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Elderly
- What is being tested?
- gait training, gait training 2 and exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2010to Apr 2013
- 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 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- between the ages of 65-85
- independent in activities of daily living
- able to walk without assistance for at least 10 minutes
- cognitively intact (Mini Mental State Exam ≥24)
- reported 2 or more falls within 6 months prior to the beginning of the study
Who cannot join
- any neurological, orthopedic or any other impairment likely to impact gait.
- severe visual impairments
- major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Anat Mirelman, PhD, +972 3 6974958, anatmi@tasmc.health.gov.il
Nir Giladi, MD
About this study
Official title: Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population
The study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.
Read the detailed description
The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.
- Conditions
- Elderly
- Being tested
- gait training, gait training 2, exercise group
- Keywords
- Gait, Falls, Virtual reality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait trainingOther
Also called virtual reality
subjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device
gait training 2Other
Also called treadmill
subjects will walk on a treadmill under a progressive intensive gait protocol
exercise groupOther
standard of care exercise group to improve strength and balance
| Study group | Role | What they receive |
|---|---|---|
| Treadmill +virtual reality training | Experimental | Not described Receives: Other: gait training |
| Treadmill alone | Active comparator | Not described Receives: Other: gait training 2 |
| standard of care exercise group | Active comparator | Not described Receives: Other: exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait dynamics
using an accelerometer, the coefficient of variation will be calculated
Measured: one week after training
Secondary outcomes (1)
cognitive function
using a cmputerized cognitive battary and neuropsychological testing
Measured: one week after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionApr 2013 (estimated)
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 Tel-Aviv Sourasky Medical CenterThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- Nir Giladi, MD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182961
- Sponsor's protocol ID
- TASMC-10-NG-0113-CTIL
- Acronym
- VR-Fallers
- Status last verified
- Aug 2010
- First submitted
- 20 Jul 2010
- Last updated
- 30 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Training Intervention to Evaluate the Efficacy of Using Virtual Reality to Decrease Fall Risk in the Elderly Population
- ClinicalTrials.gov ID
- NCT01182961
- Acronym / sponsor ID
- VR-Fallers / TASMC-10-NG-0113-CTIL
- Conditions
- Elderly
- Keywords
- Gait, Falls, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 17 Aug 2010 (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 study aims to investigate the efficacy of gait training using virtual reality to decrease the risk of falls in elderly idiopathic fallers. The investigator hypothesize that training with virtual reality would increase the ability to perform in the "real world" environment and decrease the risk of falls in elderly adults.
Detailed description
The study is a prospective single-blinded randomized control study with repeated measures at pre intervention, post intervention and follow up at 3 and 6 months post intervention. For six months after termination of the intervention, all subjects will fill out a log book in which they will write the occurrence and date of falls. total time of participation in the study will be 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treadmill +virtual reality training | Experimental | Other: gait training |
| Treadmill alone | Active comparator | Other: gait training 2 |
| standard of care exercise group | Active comparator | Other: exercise group |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- between the ages of 65-85
- independent in activities of daily living
- able to walk without assistance for at least 10 minutes
- cognitively intact (Mini Mental State Exam ≥24)
- reported 2 or more falls within 6 months prior to the beginning of the study
Key exclusion criteria (3 listed)
- any neurological, orthopedic or any other impairment likely to impact gait.
- severe visual impairments
- major depression as defined by the Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria
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 |
|---|---|---|
| gait trainingAlso: virtual realitysubjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device | Other | Treadmill +virtual reality training |
| gait training 2Also: treadmillsubjects will walk on a treadmill under a progressive intensive gait protocol | Other | Treadmill alone |
| exercise groupstandard of care exercise group to improve strength and balance | Other | standard of care exercise group |
Primary outcome
Gait dynamics
Time frame: one week after training
using an accelerometer, the coefficient of variation will be calculated
1 secondary outcome
cognitive function
Time frame: one week after training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2010.
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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.
Nir Giladi, MD principal investigator
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait training, gait training 2 and exercise group in people with Elderly, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2010. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anat Mirelman, PhD (+972 3 6974958, anatmi@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait dynamics (time frame: one week after training). 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 30 Aug 2010.