The primary objective is to study the effects of 12 weeks of treadmill training with virtual reality on neural plasticity in comparison to the effects of treadmill training without virtual reality.Secondary objectives are to investigate the role of…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the change in blood oxygenation level dependent
(ΔBOLD) signal in the bilateral anterior putamen during performance of a dual
task containing a lower limb motor task and a cognitive task (pre-training vs.
post-training assessment).
Secondary outcome
Secondary study parameters include the change in blood oxygenation level
dependent (ΔBOLD) signal in the bilateral caudate nucleus, the anterior
cingulate cortex and the prefrontal cortex, during performance of a dual task
containing a lower limb motor task and a cognitive task (pre-training vs.
post-training assessment). Other secondary study parameters are prefrontal
cortex activation (concentration of oxygenated and deoxygenated heamoglobin)
during training and more general walking tasks (dual task walking, obstacle
negotiation, walking at preferred speed). Also, magnetic resonance imaging will
be used to obtain brain oxygenation levels during ankle movements and a
cognitive task, resting state functional connectivity, grey matter volume and
white matter integrity. Other secondary study parameters are measures of gait,
fall frequency, balance and mobility, community ambulation, cognitive
functioning, health related quality of life, fear of falling and user
satisfaction of the intervention. A pre-training vs. post training assessment
will be used for all secondary study parameters.
Background summary
Falls are a major public health concern, especially in patients with
Parkinson*s disease. Since gait and balance control are related to cognitive
function, fall-prevention should focus on both cognitive and motor aspects.
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. 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 intervention. Recent pilot studies in elderly
fallers and patients with Parkinson*s disease showed promising results. This
randomized controlled trial aims to confirm these results and to identify
neural mechanisms that underlie training effects.
Study objective
The primary objective is to study the effects of 12 weeks of treadmill training
with virtual reality on neural plasticity in comparison to the effects of
treadmill training without virtual reality.
Secondary objectives are to investigate the role of the prefrontal cortex in
treadmill training with and without virtual reality, to determine transfer of
training effects to prefrontal cortex activation during more general walking
tasks, to relate neural changes to behavioural effects, to compare the effect
of different training durations and to investigate long term training effects.
Study design
A prospective, single-blind randomized controlled trial, with 12 weeks of
training and four assessments: i.e. pre-training, post-training, at one month
follow-up, and six months follow-up period. Two centres will be involved:
Radboud University Nijmegen Medical Centre (RUNMC; 50 PD) and Tel Aviv Sourasky
Medical Centre (TASMC; 40 PD, for which ethical approval will be obtained at
their own site).
Intervention
After consent, participants will be randomized to one of two arms of the study:
1. Treadmill Training with Virtual Reality (TT+VR); 2. Active control
comparison of Treadmill Training alone (TT). To ensure comparable
representation of men and women, randomization allocation will take place
within gender.
Study burden and risks
The outcome of this study may have important consequences for fall prevention
in patients with Parkinson*s disease, reducing serious consequences of falling
for the patient, but also their family and the society. As falling has an
enormous economic burden, a new effective fall prevention intervention could
reduce health care costs substantially. Besides, neural mechanisms underneath
intervention effects will be identified. This might be used as target for
future interventions. The tests consisting of questionnaires, gait and
cognition assessment and brain imaging are non-invasive and safe. However,
participants may be burdened by the time-investment for the training and
measurements, which are time-consuming.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
Patients are eligible for participation if they meet all of the following inclusion criteria:
- >=2 falls within the 6 months prior to the study
- Age range: 60-85 years
- Diagnosis of PD (UKBB criteria)
- Hoehn and Yahr stage II-III (on medication)
- Stable medication for at least one month and anticipated for the next 6 months
- Able to walk at least 5 minutes unassisted
- Adequate hearing and vision
Exclusion criteria
Patients 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
- Severe freezing precluding safe participation (>15 on New Freezing of Gait Questionnaire)
- Metal objects or fragments in/on body
- Active implant (e.g. pacemaker, neurostimulator, insulin pump)
- Epilepsy
- Claustrophobia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41661.091.12 |
| OMON | NL-OMON23705 |