Frail ElderlyNCT01607736
Pilot Study of Virtual Gait Training in Older Adults
A study testing Virtual Gait Training in people with Frail Elderly, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Older individuals suffer from falls and fear of falling. The purpose of this study was to determine the effectiveness of a novel virtual gait training on walking performance and fear of falling in older adults, and to evaluate the feasibility of the virtual gait training program. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frail Elderly
- What is being tested?
- Virtual Gait Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2011to Aug 2011
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- older than 65 years of age
- fall within last 6 months
Who cannot join
- cognitive deficits
- physical disability
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of Effects of Virtual Gait Training on Walking Stability in Older Adults
Older individuals suffer from falls and fear of falling. The purpose of this study was to determine the effectiveness of a novel virtual gait training on walking performance and fear of falling in older adults, and to evaluate the feasibility of the virtual gait training program. The investigators hypothesize that virtual gait training in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.
Read the detailed description
The objectives of this study are to determine the effectiveness of virtual gait training on walking performance and fear of falling in older adults and to evaluate the feasibility of the virtual gait training. This prospective interventional study plans to include twelve residents of senior assisted living facilities in Basel, Switzerland, aged 65 years or older with no severe physical or cognitive disabilities, and who had fallen at least once in the preceding 12 months. Each participant will complete 14 12-minute virtual gait training sessions within a three-week period. Gait parameters will be quantified with the GAITRite® electronic walkway system, and fear of falling evaluated with the Falls Efficacy Scale-International version. The investigators hypothesize that 14 virtual gait training sessions in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.
- Conditions
- Frail Elderly
- Being tested
- Virtual Gait Training
- Keywords
- falls, walking, healthy older individuals, virtual gait training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Gait TrainingBehavioural
The intervention consisted of 12-minute virtual gait training sessions once daily for a total of 14 weekdays within a three-week period. The intervention video showed walking legs of a 30-year-old woman for female and a 46-year-old man for male participants. The video screen was adjusted in height such that it corresponded to the legs of the standing participant, with a mirror placed above it. Participants began the training session with a circa one minute of concentration on the upcoming intervention. Afterwards, the video was started. Participants were instructed to stand (when necessary, to sit) and observe the video and mirror, and to imagine themselves walking. Training sessions were supervised by a physical therapist who gave additional instructions and comments regarding participants' visual/kinesthetic imagination of themselves performing the observed movement. Verbal and physical reactions during training sessions were documented in written form and sometimes videotaped.
| Study group | Role | What they receive |
|---|---|---|
| Inactive Comparator | No intervention | Not described |
| Virtual Gait Training | Experimental | Not described Receives: Behavioral: Virtual Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed
gait speed measure with GAITRite® electronic walkway system
Measured: Change from baseline in gait speed at 3 weeks
Secondary outcomes (1)
fear of falling
total score on Falls Efficacy Scale-International version
Measured: change from baseline at end of week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2012 (estimated)
- Study startMay 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reto W Kressig, MD, Principal investigator, Dept. of Geriatrics, University Hospital Basel, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01607736
- Sponsor's protocol ID
- JBMP-VGTinOA-pilot
- Other IDs
- EK:113/11
- Status last verified
- May 2012
- First submitted
- 16 May 2012
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Effects of Virtual Gait Training on Walking Stability in Older Adults
- ClinicalTrials.gov ID
- NCT01607736
- Acronym / sponsor ID
- JBMP-VGTinOA-pilot
- Conditions
- Frail Elderly
- Keywords
- falls, walking, healthy older individuals, virtual gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 30 May 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.
Older individuals suffer from falls and fear of falling. The purpose of this study was to determine the effectiveness of a novel virtual gait training on walking performance and fear of falling in older adults, and to evaluate the feasibility of the virtual gait training program. The investigators hypothesize that virtual gait training in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.
Detailed description
The objectives of this study are to determine the effectiveness of virtual gait training on walking performance and fear of falling in older adults and to evaluate the feasibility of the virtual gait training. This prospective interventional study plans to include twelve residents of senior assisted living facilities in Basel, Switzerland, aged 65 years or older with no severe physical or cognitive disabilities, and who had fallen at least once in the preceding 12 months. Each participant will complete 14 12-minute virtual gait training sessions within a three-week period. Gait parameters will be quantified with the GAITRite® electronic walkway system, and fear of falling evaluated with the Falls Efficacy Scale-International version. The investigators hypothesize that 14 virtual gait training sessions in older adults over a three week period will both improve gait parameters as measured by a GAITRite® electronic walkway system, and reduce their fear of falling as measured by the Falls Efficacy Scale-International version.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inactive Comparator | No intervention | – |
| Virtual Gait Training | Experimental | Behavioral: Virtual Gait Training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- older than 65 years of age
- fall within last 6 months
Key exclusion criteria (2 listed)
- cognitive deficits
- physical disability
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 Gait TrainingThe intervention consisted of 12-minute virtual gait training sessions once daily for a total of 14 weekdays within a three-week period. The intervention video showed walking legs of a 30-year-old woman for female and a 46-year-old man for male participants. The video screen was adjusted in height such that it corresponded to the legs of the standing participant, with a mirror placed above it. Participants began the training session with a circa one minute of concentration on the upcoming intervention. Afterwards, the video was started. Participants were instructed to stand (when necessary, to sit) and observe the video and mirror, and to imagine themselves walking. Training sessions were supervised by a physical therapist who gave additional instructions and comments regarding participants' visual/kinesthetic imagination of themselves performing the observed movement. Verbal and physical reactions during training sessions were documented in written form and sometimes videotaped. | Behavioural | Virtual Gait Training |
Primary outcome
gait speed
Time frame: Change from baseline in gait speed at 3 weeks
gait speed measure with GAITRite® electronic walkway system
1 secondary outcome
fear of falling
Time frame: change from baseline at end of week 3
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 30 May 2012.
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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.
Reto W Kressig, MD principal investigator
Dept. of Geriatrics, University Hospital Basel, Basel, Switzerland
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 Gait Training in people with Frail Elderly, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 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 30 May 2012. 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 Switzerland. 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?
gait speed (time frame: Change from baseline in gait speed at 3 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 30 May 2012.