The aim of the study is to investigate the effect of vibrotactile feedback on exoskeleton use in people with complete spinal cord injury.
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 measure is the walking distance covered.
Secondary outcome
The secondary outcome measures are:
- Crutch loading
- Center of mass movement smoothness
- User experience
Background summary
People with complete spinal cord injury (SCI) lack motor function below the
lesion level and are, thus, wheelchair-dependent. In recent years, wearable
exoskeletons have emerged as potential mobility devices for this population.
Although exoskeletons generate the basic motions for ambulation, postural
stability must be maintained by the user. People with complete SCI miss
essential somatosensory perception, which affects their ability to maintain
postural stability. Hence, walking in an exoskeleton is demanding, and crutches
are necessary.
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 people missing
essential sensory information, such sensory substitution may also be
effectively incorporated in people with complete SCI using an exoskeleton.
Study objective
The aim of the study is to investigate the effect of vibrotactile feedback on
exoskeleton use in people with complete spinal cord injury.
Study design
The proposed study is an experimental study.
Study burden and risks
The study protocol includes six two-hour sessions spread over three weeks.
Sessions 1 to 5 are training sessions, and session 6 is an evaluation session.
The training sessions are similar to the sessions of the clinical exoskeleton
training program of the Sint Maartenskliniek. The study provides opportunities
for people with complete SCI to use an exoskeleton without reimbursing it
themselves. The exoskeleton we use in the study is the ABLE Exoskeleton.
Previous research has shown that the ABLE Exoskeleton is safe and feasible for
gait training. Reported medium-level risks of the ABLE Exoskeleton could
potentially lead to falls or skin injuries. However, these risks are well-known
for the use of all exoskeletons, and we took mitigation measures to address the
potential risks.
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 being able to walk in this
exoskeleton without a therapist
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82999.091.22 |