- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01607736
Pilot Study of Virtual Gait Training in Older Adults
May 29, 2012 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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BS
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Basel, BS, Switzerland, 4031
- Mobility Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- older than 65 years of age
- fall within last 6 months
Exclusion Criteria:
- cognitive deficits
- physical disability
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Inactive Comparator
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|
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EXPERIMENTAL: Virtual Gait Training
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
gait speed
Time Frame: Change from baseline in gait speed at 3 weeks
|
gait speed measure with GAITRite® electronic walkway system
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Change from baseline in gait speed at 3 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
fear of falling
Time Frame: change from baseline at end of week 3
|
total score on Falls Efficacy Scale-International version
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change from baseline at end of week 3
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Reto W Kressig, MD, Dept. of Geriatrics, University Hospital Basel, Basel, Switzerland
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (ACTUAL)
August 1, 2011
Study Completion (ACTUAL)
August 1, 2011
Study Registration Dates
First Submitted
May 16, 2012
First Submitted That Met QC Criteria
May 29, 2012
First Posted (ESTIMATE)
May 30, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
May 30, 2012
Last Update Submitted That Met QC Criteria
May 29, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Other Study ID Numbers
- JBMP-VGTinOA-pilot
- EK:113/11 (OTHER_GRANT: Velux Foundation Grant Project Number 727)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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