|- candidate number||26637|
|- NTR Number||NTR6215|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-feb-2017|
|- Secondary IDs||NL59737.048.16 P1668 METC Slotervaartziekenhuis en Reade|
|- Public Title||Does virtual reality gait training improve participation in patients after stroke?|
|- Scientific Title||Does virtual reality gait training improve participation after a stroke?|
|- hypothesis||The objective of the 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.|
|- Healt Condition(s) or Problem(s) studied||Stroke, Gait pattern|
|- Inclusion criteria||Participants should comply to the following inclusion criteria:|
- Diagnosed with stroke according to the definition of the WHO
- Time since stroke between 2 weeks and 6 months
- Independently living
- Minimal Functional Ambulation Category score of 3
- Experiencing constrains with walking
- Age older than 18 and younger than 80
|- Exclusion criteria||Potential participants who meet one of the following exclusion criteria are excluded:|
- Insufficient cognitive skills or understanding of the Dutch language 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
- Epileptic seizures
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-mrt-2017|
|- planned closingdate||1-mrt-2019|
|- Target number of participants||56|
|- Interventions||The intervention group (28 persons) receives 2 virtual reality training sessions of 30 minutes per week for 6 weeks. The virtual reality training is performed on the Gait Real-time Analysis Interactive Lab (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 degrees semi-cylindrical screen. Participants can practice walking ability in combination with extra cognitive tasks or tasks using the upper extremity within the virtual environment of the GRAIL.
Patients assigned to the control group (28 persons) receive functional gait training of 30 minutes 2 times per week for 6 weeks. The functional gait training will take place on a conventional treadmill for half of the training. The other half of a training session functional gait exercises are performed.
|- Primary outcome||Participation assessed with the Utrecht Scale for Evaluation of Rehabilitation Participation (USER-P)|
|- Secondary outcome||- 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) and the 6 minute 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 a training session with the Borg RPE Scale
|- Timepoints||Baseline, after the 6-week training intervention and after 3 months of follow-up|
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc Ilona de Rooij|
|- CONTACT for SCIENTIFIC QUERIES||dr. Ingrid Port, van de|
|- Sponsor/Initiator ||Revant medisch specialistische revalidatie|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale:|
Many patients after stroke experience limitations in walking and physical functioning in daily life,
mainly because of difficulties with performing dual tasks and walking on unlevel surfaces, walking up-
or downhill and walking on stairs. These limitations in walking provoke a reduced activity and
participation level. 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
the home environment.
The primary 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. Secondary research questions are: What is the effect of virtual gait training on walking
ability in patients between 2 weeks and 6 months after stroke? What is the difference in intensity
between virtual treadmill training and conventional functional gait training? Does gait training on a
treadmill in a virtual environment lead to improved quality of life?
A randomized controlled trial will be conducted to compare virtual gait training (experimental group)
with functional gait training (control group).
Patients with stroke between 2 weeks and 6 months after stroke who are living independently.
Participants are experiencing constraints with walking and are minimally able to walk without manual
support (FAC 3).
Patients in the experimental group will receive virtual gait training on the Gait Real-time Analysis
Interactive Lab (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.
Participants will train 2 times per week for 6 weeks.
The primary outcome measure is participation assessed with the Utrecht Scale for Evaluation of
Rehabilitation Participation (USER-P). Secondary outcome measures are: subjective physical
functioning (SIS-16), functional gait ability (TUG, 6 minutes walking test), fatigue (FSS), anxiety and
depression (HADS), falls efficacy (FES-I), quality of life (SS-QOL) and daily life activity level measured
with an accelerometer.
|- Main changes (audit trail)|
|- RECORD||3-feb-2017 - 8-mei-2017|