The aim of this study is to investigate the effect of discrete vibrotactile feedback of mediolateral weight shift and step initiation for complete SCI patients on the use of an exoskeleton.
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the maximal weight transfer onto a single limb
during a standing lateral weight-shifting exercise, the mean velocity of the
centre of pressure during quiet stance and the walked distance during one
minute of straight walking.
Secondary outcome
The amount of weight exerted onto the crutches during quit stance, maximal
weight shift and at heel strike during gait. Furthermore, the patients
experience will be evaluated with the QUEST-score part I, the SUS-score and a
VAS-score.
Background summary
Complete Spinal Cord Injury (SCI) patients lack motor function below the level
of lesion and are wheelchair dependent. Exoskeletons give complete SCI patients
the ability to walk individually. Although exoskeletons generate the basic
motions for ambulation, postural stability has to be maintained by the user.
However, the ability of complete SCI patients to maintain postural stability is
affected. This is because complete SCI patients miss essential somatosensory
information from below their level of lesion. Hence, walking in an exoskeleton
is demanding and crutches are necessary to maintain balance. When sensory
information of a specific system is lost, the lack of sensory information can
be substituted by providing feedback to another sensory system. As sensory
feedback has shown to improve postural control in patients missing essential
sensory information, such sensory substitution may also be effectively
incorporated in complete SCI patients using an exoskeleton.
Study objective
The aim of this study is to investigate the effect of discrete vibrotactile
feedback of mediolateral weight shift and step initiation for complete SCI
patients on the use of an exoskeleton.
Study design
Experimental pilot study.
Study burden and risks
During the study, subject visit the clinic twice. During these visits of one
and a half hour, subjects have the opportunity to train and use an exoskeleton
again without reimbursing it themselves. Furthermore, subjects fill in three
questionnaires about their experiences. This will take approximately 10
minutes. There are no disadvantages to the research since the risks are similar
to the clinical training sessions provided during the exoskeleton training
program of the Sint Maartenskliniek. Besides, mitigation measuers have been
taken to address potential risks of the vibrotactile feedback system.
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Reinier Postlaan 4
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
- SCI classification ASIA A or B
- Level of SCI between T1 and L1
- Age >= 18
- Having experience with the ReWalk exoskeleton and able to walk without a
physiotherapist
Exclusion criteria
- Somatosensory problems prior to the complete SCI
- Visual or auditory problems that are not resolved with glasses or a hearing
device
- Insufficient mastery of the Dutch language
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 | NL74476.091.20 |
| OMON | NL-OMON26174 |