To demonstrate the extent to which an intervention that combines treadmill training augmented by virtual reality (TT+VR) reduces fall risk, improves mobility and enhances cognitive function in a diverse group of older adults, compared to a treadmill…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is fall incidence rate during the 6 month
post-training follow-up period, as assessed with a falls calendar.
Secondary outcome
Secondary outcome measures include gait, cognition, mobility, health related
quality of life and prefrontal activation during walking.
Background summary
Falls are a major public health concern. Recent work has demonstrated that fall
risk can be attributed to cognitive as well as motor deficits. Indeed, everyday
walking in complex environments utilizes executive function, dual tasking,
planning and scanning, all while walking forward. To reduce fall risk,
fall-prevention should thus focus on both cognitive and motor aspects. These
additional training goals that aim to enhance the cognitive aspects of mobility
have not yet been integrated into common practice and are one of the important
added features of the proposed V-TIME training.
Study objective
To demonstrate the extent to which an intervention that combines treadmill
training augmented by virtual reality (TT+VR) reduces fall risk, improves
mobility and enhances cognitive function in a diverse group of older adults,
compared to a treadmill training (TT).
Study design
An international multi-centre, prospective, single-blind randomized controlled
trial, with 6 weeks of training and four assessments: i.e. pre-training,
post-training, at 1 month follow-up, and 6 months follow-up period. Five
centres will be involved: University of New Castle (UNEW), United Kingdom;
University of Leuven (KULeuven), Belgium; Tel Aviv Sourasky Medical Centre
(TASMC), Israel; University of Genoa (UNIGE), Italy; Radboud University
Nijmegen Medical Centre (RUNMC), the Netherlands. Each centre will obtain
ethical approval at their own site.
Intervention
After consent, participants will be randomized to either *Treadmill Training
with Virtual Reality* (TT+VR) or *Active control comparison of Treadmill
Training alone* (TT). The training will be provided 3 times a week for 6 weeks,
for a total of 18 sessions. V-TIME is a multi-modal intervention centred around
treadmill training, promoting motor control, usual-walking abilities and
physical fitness, and addressing cognitive issues that are key to falls.
Addition of the virtual reality environment implicitly challenges, teaches, and
enhances visual scanning, planning, dual tasking abilities and obstacle
negotiation.
Study burden and risks
Fall risk may be decreased and fitness may be improved, which substantially
lowers burden on patients, family and economy. In addition, the comparison to
the active control group will provide evidence about the added value of
addressing motor-cognitive interactions as integrated unit.
The tests are non-invasive and safe. During training, participants wear a
harness to protect them from falling. Participants may be burdened by the
time-investment for the training and measurements, which are time-consuming. At
any time during the study the participant may stop and or request to rest. If
he/she decides they do not wish to continue they may drop out of the study with
no consequences to them. There will be no expenses or costs for participating
in the study.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Older fallers and patients with MCI are eligible for participation if they meet all of the following inclusion criteria: ;• >=2 falls within the 6 months prior to the study
• Aged 60-85 years
• Able to walk at least 5 minutes unassisted
• Adequate hearing and vision
• Stable medication for >=1 month and anticipated for the next 6 months;The following criteria are specific for either the older fallers or the MCI group.;Specific for the older fallers:
• Clinical Dementia Rating (CDR) score = 0.0;Specific for the patients with MCI:
• Diagnosis of MCI; CDR score = 0.5
Exclusion criteria
Older fallers and patients with MCI will be excluded from the study if they meet any of the following criteria: ;• Psychiatric co-morbidities (e.g., major depression - DSM IV criteria)
• Clinical diagnosis of dementia (e.g., Alzheimer*s, vascular, etc.)
• History of stroke, traumatic brain injury, brain tumour or other neurological disorders
• Acute lower back or lower extremity pain, musculoskeletal injuries, peripheral neuropathy which restricts gait
• Unstable medical condition including cardiovascular instability in past 6 months
• Unable to comply with training
• Cognitively impaired (< 24 on Mini-Mental State Examination)
• Interfering therapy, or fall clinic visit <1 month ago
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41735.091.12 |