The objective of this study is to investigate the effect of virtual reality training, given between 2 weeks and 6 months after stroke, on participation and subjective physical functioning in independently living patients .Primary research question:…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is participation assessed with the Utrecht Scale
for Evaluation of Rehabilitation Participation (USER-P).
Secondary outcome
The following secundary outcome measures are assessed:
- Subjective physical functioning with the Stroke Impact Scale-16 (SIS-16)
- Activity level measured with an accelerometer
- Functional gait ability with the Timed-Up & Go Test (TUG), Mini Balance
Evaluation Systems Test (Mini-BESTest) and the 6 minutes walking test.
- Fatigue with the Fatigue Severity Scale (FSS)
- Anxiety and depression with the Hospital Anxiety and Depression Scale (HADS)
- Falls efficacy with the Falls Efficacy Scale International (FES-I)
- Quality of life with the Stroke Specific Quality of Life Scale (SS-QOL)
- Intensity of the training sessions with a pedometer
- Perceived exertion at the end of the training sessions with the Borg RPE
Scale.
Background summary
Many patients after stroke experience limitations in walking and physical
functioning in the home environment, mainly because of difficulties with
walking on unlevel surfaces, walking up- or downhill and walking on stairs. In
addition, patients after stroke experience difficulties with performing dual
tasks for example when they need to navigate thru a busy environment while
walking. These limitations in walking provoke a reduced activity and
participation level. Recently virtual reality is introduced in the
rehabilitation of stroke survivors. While using virtual reality training
patients can be challenged more when compared to other forms of gait training,
for example by adding visual input and feedback, perturbations and dual tasks
during walking. It has been demonstrated that virtual reality training improves
functional outcome measures in people after stroke. However, there is a lack of
measuring follow-up and research on the effect of virtual reality training on
activity and participation level is missing. Therefore, it is unclear whether
the effects of virtual training are translated in improved daily life activity
and participation in their home environment. Revant Rehabilitation Centres has
the opportunity to provide patients virtual reality training with the Gait
Real-time Analysis Interactive Lab (GRAIL). To study the effect of virtual
reality training on walking ability, participation and subjective physical
functioning, virtual gait training will be compared to functional gait training
in patients within 2 weeks and 6 months after stroke. It is hypothesised that
gait training using virtual reality will have a greater effect on walking
ability, participation and subjective physical functioning than functional gait
training in patients after stroke.
Study objective
The objective of this study is to investigate the effect of virtual reality
training, given between 2 weeks and 6 months after stroke, on participation and
subjective physical functioning in independently living patients .
Primary research question:
What is the effect of virtual gait training on the GRAIL, given between 2 weeks
and 6 months after stroke, on participation and subjective physical functioning
in independently living patients .
Secondary research questions:
1) What is the effect of virtual gait training on the GRAIL on walking ability
in patients between 2 weeks and 6 months after stroke?
2) What is the difference in intensity between virtual treadmill training and
conventional functional gait training?
3) Does gait training on a treadmill in a virtual environment lead to improved
quality of life?
Study design
A randomised controlled trial will be conducted to compare virtual gait
training (experimental group) with functional gait training (control group).
Both groups receive 2 training sessions per week during 6 weeks. Virtual gait
training is performed on the treadmill of the GRAIL.
Intervention
The virtual gait training is performed on the GRAIL. The GRAIL comprises a
dual-belt treadmill with force platform, a motion-capture system (Vicon) and
speed-matched virtual environments projected on a 180° semi-cylindrical screen.
Participants can practise balance and walking ability in combination with extra
cognitive tasks or tasks using the upper extremity within the virtual
environment of the GRAIL.
Training in the control group will take place on a conventional treadmill for
half of the training. The other half of a training session functional gait
exercises are performed. Both the experimental and control group will train 2
times per week for 6 weeks.
Study burden and risks
Participants who are willing to participate receive 30 minutes of training for
2 times per week during 6 weeks. This is 6 hours in total. Besides, three
measurements of 1 hour and 15 minutes will take place before the intervention,
after the intervention and after 3 months of follow-up. In addition,
participants wear an accelerometer on the lower back for 3 times over a period
of 5 days. This requires effort of the participants in both the experimental
group and control group. In return patients may benefit from the training.
Risks of participating in this study are limited. Training in the control group
will be performed by physiotherapists who are experienced with the patient
population and the use of conventional treadmills. Training in the experimental
group is performed by physiotherapists who are certified for using the system.
In addition, the training sessions will start at the preferred speed of the
participants and will be increased with small steps. Also, short rest periods
can be inserted during the training sessions.
Brabantlaan 1
Breda 4817JW
NL
Brabantlaan 1
Breda 4817JW
NL
Listed location countries
Age
Inclusion criteria
- Diagnosed with stroke according to the definition of the WHO
- Time since stroke between 2 weeks and 6 months
- Independent living
- Minimal Functional Ambulation Category (FAC) score of 3
- Experiencing constrains with walking
- Age from 18 to 80 years
Exclusion criteria
- Insufficient cognitive skills or understanding of the Dutch langue to reliably answer simple questions, based on the clinical impression of the researcher
- Severe visual deficits
- Severe forms of ataxia
- Orthopedic disorders and other co-morbidities that may limit walking ability
- Poorly controlled epilepsy
Design
Recruitment
Medical products/devices used
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 | NL59737.048.16 |
OMON | NL-OMON26087 |