1. To evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke in an RCT. 2. To identify patient characteristics…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Time needed to complete the modified Emory Functional Ambulation Profile
obstacle task
Time needed (+ penaly time for errors) to complete the Walking Adaptability
Ladder Task
Secondary outcome
- Gait metrics derived from wearable sensors during the WALT
- Foot placement errors during the Target Stepping Task
- Quantity (number of steps) of daily life gait performance
- Quality of daily life gait performance (activity intensity, dynamic stability)
- Gait stability assessed during treadmill walking with and without
perturbations
Background summary
After stroke, a major impairment is a decreased ability to adapt gait to meet
environmental demands. Rehabilitation programs targeting gait adaptability have
gained interest in clinical practice, yet evidence for the efficacy of these
interventions is limited to small, pilot trials. Moreover, it is unclear if and
how the retention of beneficial effects of the intensive, but short-duration
training programs can be maintained in the long run through booster sessions
(single training sessions every 3 months) or an unsupervised home exercise
program. We hypothesize that treadmill-based training with virtual and
augmented reality will improve gait adaptability in post-stroke patients when
compared to the standard care provided during a waiting-list control period. We
also hypothesize that providing booster sessions and/or unsupervised home-based
practice will yield better retention of training effects at 1 year follow-up as
compared to the control arm.
Study objective
1. To evaluate the efficacy of a gait training program using an instrumented
treadmill with virtual and augmented reality for improving gait adaptability in
people in the chronic phase after stroke in an RCT.
2. To identify patient characteristics that predict a favorable response to
training.
3. To evaluate if retention of training-induced gains in gait adaptability can
be fostered by providing booster sessions and/or by prescribing unsupervised
home-based training.
Study design
We will use a waitlist controlled trial in this study (Study 1), to evaluate
the short-term effect of gait adaptability training using augmented reality (on
the C-Mill) in individuals in the chronic phase after stroke. Following the
post-intervention assessment of Study 1 (S1-T1), all waitlist control
participants will enrol in the gait adaptability training. They will undergo an
additional assessment after completion of the training period (S1-T2). In the
second part of the study, to evaluate the long-term effects of gait
adaptability training, the patients who completed the gait adaptability
training will be randomized (1:1:1) to one of three arms: booster sessions,
home-based exercise program or a control arm. For the group randomized to gait
adaptability training in study 1, we will use the post-intervention assessment
of study 1 as baseline assessment for study 2 (S1-T1 = S2-T0) . For the
wait-list control group, the additional assessment after completion of the
training will be used as baseline assessment in study 2 (S1-T2 = S2-T0).
Follow-up assessment will be done at 6 (S2-T1) and 12 (S2-T2) months following
start of the intervention.
Intervention
Gait adaptability training with instrumented treadmill with augmented reality
(C-Mill)
Study burden and risks
Health risks are minimal.
Burden will consist of the effort to do the assessments, training sessions and
travel to the Sint Maartenskliniek
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
* >6 months after first unilateral supratentorial stroke (chonic phase)
* No contractures or spasticity requiring other treatments within the duration
of the training period of study 1
Exclusion criteria
* any other neurological or musculoskeletal disease affecting gait or balance
(e.g. Parkinson*s disease, knee osteoarthritis)
* unable to walk 10min without walking aid
* Has received multiple training sessions on C-Mill of GRAIL in the past 12
months
* severe cognitive or visuo-spatial impairments limiting comprehension of
instructions or correct perception of the environments
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 | NL80178.091.21 |