Elderly AdultsVTIMENCT01732653
A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults
A study testing TT+VR and TT alone in people with Elderly Adults and Parkinson, run by Tel-Aviv Sourasky Medical Center at 5 sites in 5 countries.
Trial summary
The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk. 300 older adults with a history of falls will be recruited to participate in this study. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Elderly Adults, Parkinson, Mild Cognitive Disorder
- What is being tested?
- TT+VR and TT alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 5 sitesin 5 countries
- Study dates
- Nov 2012to Dec 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2 or more falls within 6 months prior to the beginning of the study
- Aged 60-85 years
- Able to walk for 5 minutes unassisted
- Adequate hearing and vision capabilities.
- Stable medication for the past 1 month and anticipated over a period of 6 months
Who cannot join
- Psychiatric co-morbidity
- Clinical diagnosis of dementia or other severe cognitive impairment (MMSE<24)
- History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
- Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
- Unstable medical condition in the past 6 months
- Unable to comply with the training
- Interfering therapy
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
Belgium1 site
Department of Rehabilitation Sciences, Katholieke Universiteit Leuven
Leuven
Italy1 site
Department of Neurosciences Universita Degli Studi Di Genova, Italy
Genova
Netherlands1 site
Department of Geriatric Medicine and Neurology, Radboud University Nijmegen Medical Center The Netherlands
Nijmegen
United Kingdom1 site
Institute for Aging and Health, University of Newcastle, UK
Newcastle
About this study
Official title: V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
The proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.
300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.
Read the detailed description
A prospective, single blinded, parallel group, randomized controlled trial with 6 month follow-up will be employed to investigate the effects of treadmill training augmented with virtual reality on fall risk. The study will include 300 older participants who have experienced two or more falls in the previous 6 months. Participants will be randomized to either the intervention or control group. The intervention group will receive 18 sessions of Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will receive 18 training sessions of treadmill training alone (TT) without the VR simulation All interventions will be delivered by therapists trained in the standard protocols. All subjects will be trained 3 times a week for 6 weeks, each session will last approximately 45 minutes.Training progression will be based on increasing both motor and cognitive challenges, individualized to the participant's level of performance.
Primary outcome measures:
The primary outcome measure of the study is fall rate for 6 months post intervention. Secondary outcome measures will include gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Endurance will be assessed using the 2 Minute Walk Test and mobility will be assessed using the Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest). Community ambulation will be assessed using a tri-axial accelerometer ('Axivity' Ltd.)which will be worn by the participants for 7 days. Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, 'NeuroTrax' Corp., NJ) as well as standardized neuropsychological tests (Montreal Cognitive Assessment,The Trail Making Test; Verbal Fluency). Quality of life will be evaluated using the SF-36 Health Survey
- Conditions
- Elderly Adults, Parkinson, Mild Cognitive Disorder
- Being tested
- TT+VR, TT alone
- Keywords
- virtual reality,, falls,, elderly,, Parkinson's disease,, MCI
- Medical subject headings
- Neurocognitive Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT+VROther
Also called training on a treadmill with virtual reality
subjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol.
TT aloneOther
Also called treadmill training
The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
| Study group | Role | What they receive |
|---|---|---|
| TT+VR | Experimental | The training will consist of walking on the treadmill while negotiating obstacles in a virtual reality simulation.Training will be provided3 times a week for a duration of 6 weeks (total of 18 sessions). Receives: Other: TT+VR |
| TT alone | Active comparator | The training will consist of walking on the treadmill 3 times a week for a duration of 6 weeks (total of 18 sessions). Receives: Other: TT alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Falls rate
The primary outcome measure of the study is fall rate. Participants will keep a falls calendar for 6 months post intervention. Each time the participant falls he/she will tick the date on the calendar. These calendars will be returned to the researchers once a month in a pre-addressed envelope.
Measured: 6 months post intervention
Secondary outcomes (4)
Gait
Gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Participants will be asked to walk in a well-lit corridor under 3 conditions each of 1 minute: i) walking in a comfortable speed, ii) walking while subtracting 3s from a predefined number (dual task), iii) walking while negotiating two obstacles placed on the floor at specific locations. Spatial-temporal gait characteristics (e.g., gait speed (m/s), stride length (m), stride time (s), swing time (%), asymmetry, and step width (cm)) will be determined. Endurance will be assessed using the 2 Minute Walk Test.
Measured: 6 months post intervention
Cognitive function
Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, NeuroTrax Corp., NJ). In addition, we will also include standardized neuropsychological tests such as the Montreal Cognitive Assessment (MoCA); The Trail Making Test (TMT) and the Verbal Fluency test.
Measured: 6 months post intervention
Balance and mobility
The Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest) will be used to assess mobility. Community ambulation will be assessed using The Physical Activity Scale for the Elderly (PASE) and a tri-axial accelerometer (Axivity Ltd.) which will be worn by the participants for 7 days to quantify and monitor stepping and physical activity.
Measured: 6 months post intervention
Quality of life
The SF-36 Health Survey, a generic self-report questionnaire designed to address health related quality of life will be used. Fear of Falling will be evaluated using the Falls Efficacy Scale-International.
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Elderly AdultsStudies 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
- Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Newcastle University, University Medical Center Nijmegen, Universita degli Studi di Genova, KU Leuven
- Responsible party
- Sponsor
- Investigators
- Jeffrey M Hausdorff, PhD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732653
- Sponsor's protocol ID
- TASMC-12-NG-0505-CTIL
- Other IDs
- VTIME
- Acronym
- VTIME
- Status last verified
- Apr 2016
- First submitted
- 5 Nov 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maidan I, Hacham R, Galperin I, Giladi N, Holtzer R, Hausdorff JM, Mirelman A. Neural Variability in the Prefrontal Cortex as a Reflection of Neural Flexibility and Stability in Patients With Parkinson Disease. Neurology. 2022 Feb 22;98(8):e839-e847. doi: 10.1212/WNL.0000000000013217. Epub 2021 Dec 14.
PubMed 34906983Droby A, Maidan I, Jacob Y, Giladi N, Hausdorff JM, Mirelman A. Distinct Effects of Motor Training on Resting-State Functional Networks of the Brain in Parkinson's Disease. Neurorehabil Neural Repair. 2020 Sep;34(9):795-803. doi: 10.1177/1545968320940985. Epub 2020 Jul 18.
PubMed 32684069Mirelman A, Rochester L, Maidan I, Del Din S, Alcock L, Nieuwhof F, Rikkert MO, Bloem BR, Pelosin E, Avanzino L, Abbruzzese G, Dockx K, Bekkers E, Giladi N, Nieuwboer A, Hausdorff JM. Addition of a non-immersive virtual reality component to treadmill training to reduce fall risk in older adults (V-TIME): a randomised controlled trial. Lancet. 2016 Sep 17;388(10050):1170-82. doi: 10.1016/S0140-6736(16)31325-3. Epub 2016 Aug 11.
PubMed 27524393Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.
PubMed 23388087
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- V-TIME: A Treadmill Training Program Augmented by Virtual Reality to Decrease Fall Risk in Older Adults, Patients With Parkinson's Disease and Individuals With Mild Cognitive Impairments
- ClinicalTrials.gov ID
- NCT01732653
- Acronym / sponsor ID
- VTIME / TASMC-12-NG-0505-CTIL
- Conditions
- Elderly Adults, Parkinson, Mild Cognitive Disorder
- Keywords
- virtual reality,, falls,, elderly,, Parkinson's disease,, MCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Newcastle University, University Medical Center Nijmegen, Universita degli Studi di Genova, KU Leuven
- Study start
- Nov 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Nov 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 proposed randomized controlled trial will evaluate the effects of treadmill training augmented with virtual reality on fall risk.
300 older adults with a history of falls will be recruited to participate in this study. This will include older adults (n=100), patients with mild cognitive impairment (MCI) (n=100), and patients with Parkinson's disease (PD)(n=100). Subjects will be randomly assigned to the intervention group (treadmill training with virtual reality) or to the active-control group (treadmill training without virtual reality). Each person will participate in a training program set in an outpatient setting 3 times per week for 6 weeks. Assessments will take place before, after, and 1 month and 6 months after the completion of the training.
Detailed description
A prospective, single blinded, parallel group, randomized controlled trial with 6 month follow-up will be employed to investigate the effects of treadmill training augmented with virtual reality on fall risk. The study will include 300 older participants who have experienced two or more falls in the previous 6 months. Participants will be randomized to either the intervention or control group. The intervention group will receive 18 sessions of Treadmill Training with Virtual Reality (TT+VR) and the active control comparison will receive 18 training sessions of treadmill training alone (TT) without the VR simulation All interventions will be delivered by therapists trained in the standard protocols. All subjects will be trained 3 times a week for 6 weeks, each session will last approximately 45 minutes.Training progression will be based on increasing both motor and cognitive challenges, individualized to the participant's level of performance.
Primary outcome measures:
The primary outcome measure of the study is fall rate for 6 months post intervention. Secondary outcome measures will include gait speed and gait variability under usual and dual task conditions and while negotiating physical obstacles will be measured. Endurance will be assessed using the 2 Minute Walk Test and mobility will be assessed using the Four Square Step Test (FSST), The Short Physical Performance Battery (SPPB) and the mini-Balance Evaluation Systems Test (mini-BESTest). Community ambulation will be assessed using a tri-axial accelerometer ('Axivity' Ltd.)which will be worn by the participants for 7 days. Cognitive function will be assessed using a computerized neuropsychological test battery (Mindstreams, 'NeuroTrax' Corp., NJ) as well as standardized neuropsychological tests (Montreal Cognitive Assessment,The Trail Making Test; Verbal Fluency). Quality of life will be evaluated using the SF-36 Health Survey
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT+VR | Experimental | Other: TT+VRThe training will consist of walking on the treadmill while negotiating obstacles in a virtual reality simulation.Training will be provided3 times a week for a duration of 6 weeks (total of 18 sessions). |
| TT alone | Active comparator | Other: TT aloneThe training will consist of walking on the treadmill 3 times a week for a duration of 6 weeks (total of 18 sessions). |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 2 or more falls within 6 months prior to the beginning of the study
- Aged 60-85 years
- Able to walk for 5 minutes unassisted
- Adequate hearing and vision capabilities.
- Stable medication for the past 1 month and anticipated over a period of 6 months
Key exclusion criteria (7 listed)
- Psychiatric co-morbidity
- Clinical diagnosis of dementia or other severe cognitive impairment (MMSE<24)
- History of stroke, traumatic brain injury or other neurological disorders (other than PD and MCI, for those groups)
- Acute lower back or lower extremity pain, peripheral neuropathy, rheumatic and orthopaedic diseases
- Unstable medical condition in the past 6 months
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 |
|---|---|---|
| TT+VRAlso: training on a treadmill with virtual realitysubjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol. | Other | TT+VR |
| TT aloneAlso: treadmill trainingThe participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed. | Other | TT alone |
Primary outcome
Falls rate
Time frame: 6 months post intervention
The primary outcome measure of the study is fall rate. Participants will keep a falls calendar for 6 months post intervention. Each time the participant falls he/she will tick the date on the calendar. These calendars will be returned to the researchers once a month in a pre-addressed envelope.
4 secondary outcomes
Gait
Time frame: 6 months post intervention
Cognitive function
Time frame: 6 months post intervention
Balance and mobility
Time frame: 6 months post intervention
Quality of life
Time frame: 6 months post intervention
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 19 Apr 2016.
- Derived from this study: PubMed 34906983Maidan I, Hacham R, Galperin I, Giladi N, Holtzer R, Hausdorff JM, Mirelman A. Neural Variability in the Prefrontal Cortex as a Reflection of Neural Flexibility and Stability in Patients With Parkinson Disease. Neurology. 2022 Feb 22;98(8):e839-e847. doi: 10.1212/WNL.0000000000013217. Epub 2021 Dec 14.
- Derived from this study: PubMed 32684069Droby A, Maidan I, Jacob Y, Giladi N, Hausdorff JM, Mirelman A. Distinct Effects of Motor Training on Resting-State Functional Networks of the Brain in Parkinson's Disease. Neurorehabil Neural Repair. 2020 Sep;34(9):795-803. doi: 10.1177/1545968320940985. Epub 2020 Jul 18.
- Derived from this study: PubMed 27524393Mirelman A, Rochester L, Maidan I, Del Din S, Alcock L, Nieuwhof F, Rikkert MO, Bloem BR, Pelosin E, Avanzino L, Abbruzzese G, Dockx K, Bekkers E, Giladi N, Nieuwboer A, Hausdorff JM. Addition of a non-immersive virtual reality component to treadmill training to reduce fall risk in older adults (V-TIME): a randomised controlled trial. Lancet. 2016 Sep 17;388(10050):1170-82. doi: 10.1016/S0140-6736(16)31325-3. Epub 2016 Aug 11.
- Derived from this study: PubMed 23388087Mirelman A, Rochester L, Reelick M, Nieuwhof F, Pelosin E, Abbruzzese G, Dockx K, Nieuwboer A, Hausdorff JM. V-TIME: a treadmill training program augmented by virtual reality to decrease fall risk in older adults: study design of a randomized controlled trial. BMC Neurol. 2013 Feb 6;13:15. doi: 10.1186/1471-2377-13-15.
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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.
Jeffrey M Hausdorff, PhD principal investigator
Tel-Aviv Sourasky Medical Center
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TT+VR and TT alone in people with Elderly Adults and Parkinson, run by Tel-Aviv Sourasky Medical Center at 5 sites in 5 countries.
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 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 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Israel, Italy, Netherlands, United Kingdom. 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?
Falls rate (time frame: 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732653, which also lists 4 linked publications.
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 19 Apr 2016.