Determine if the ABLE-S exoskeleton can provide subject-specific assistance (in terms of type, level and timing of the assistance) to increase forward propulsion, foot clearance and/or knee stability, in hemiplegic stroke patients.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main outcome parameters are joint angle of ankle and knee, to assess the
ankle and knee movement. In other words, the dorsiflexion and plantarflexion of
the ankle and the flexion and extension of the knee.
Secondary outcome
Secondary study parameters related to the gait analysis are spatiotemporal and
kinematic parameters, ground reaction force and muscle activity. Next to these
gait related parameters, the BORG rating scale will be administerd after each
condition and questionnaires to evaluate the usability and experience of the
patient.
Background summary
Stroke is one of the leading causes of disability of adults in the European
Union. Around 80% of stroke survivors experience deficits in motor control,
which results in gait and balance problems. The extent and amount of deficits
differ per individual Frequently occurring motor impairments are spasticity of
the plantar flexor muscles, muscle weakness of dorsiflexors and/or knee
instability. An ankle foot orthoses (AFO) is frequently used to ensure stable
and safe walking. However, a passive AFO does not support push-off, which is
frequently injured in post-stroke patients. In the current study a powered
lower extremity exoskeleton (ABLE-S) will be assessed. It should provide
assistance during the push-off to increase forward propulsion and foot
clearance and improve knee stability.
Study objective
Determine if the ABLE-S exoskeleton can provide subject-specific assistance (in
terms of type, level and timing of the assistance) to increase forward
propulsion, foot clearance and/or knee stability, in hemiplegic stroke
patients.
Study design
The current study is a cross-sectional observational study.
Study burden and risks
The current study consists of two visits to the lab of Roessingh Research and
Development. During these visits several tests will be performed with ABLE-S
and Vicon markers. There is no direct advantage for the participants and there
are no negative effects of the planned measurements because the study load is
low and there is enough room for rest between the different trials. The ABLE-S
exoskeleton is not CE-certified and the main risk is a fall risk, this will be
handled carefully by close supervision and familiarization with ZeroG.
Roessinghbleekweg 33b
Enschede 7522AH
NL
Roessinghbleekweg 33b
Enschede 7522AH
NL
Listed location countries
Age
Inclusion criteria
* Age above 18 years
* Left unilateral ischemic or haemorrhagic chronic (> 6 months) stroke
* Hemiparetic right leg
* Problems with stability in stance, insufficient push-off, problems with foot
clearance during swing and/or problems with foot prepositioning in early stance.
* Functional Ambulation Categories (FAC) score * 3, participants are able to
walk without manual assistance on a flat surface.
* Able to walk without walking aids (such as crutch, four-wheeled walker)
* Able to read and understand questionnaires and able to understand and execute
commands, both in Dutch.
Exclusion criteria
* High levels of spasticity of muscle tone (resistance to passive movement), as
represented by modified Ashworth scale scores of 3 or higher
* Premorbid disability of lower extremity
* Progressive neurological diseases like, dementia or Parkinson
* Skin lesions or severely impaired sensation at the hemiparetic leg
* Contraindication for mobilization, like lower limb fracture
* Pregnancy
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 | NL77959.000.21 |
| Other | NL9428 |