The goal of this research is to discover if there is an improvement in the walking ability when someone walks with the Foot-up compared to the plastic AFO and walking without an AFO. The Timed up-and-go test will be used to look for this improvement…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
walking ability (TUG test and walking speed)
ankle Range of Motion
ground reaction force (push-off and impact force)
Secondary outcome
toe clearance
spatio temporal parameters
experience about ease of walking, comfort and safety
Background summary
Earlier scientific research proved that plastic anklefoot-ortheses (AFO's)
improved walking ability in people with dropfoot after stroke. A disadvantage
of the current AFO's is the lack of flexibility during standing phase and
during push off. This obstructs a proper leg rotation in stance and a dynamic
push off. In addition, some users of the plastic AFO's notice a disability in
the range of motion (ROM) after some time. This could be due to the constant
position in which the AFO pushes the ankle, leading to jont contracture. The
Foot-up is a recently developed AFO who uses the own ankle joint and gives
dynamic support. This could lead to a bigger ROM. We also expect the walking
ability to improve when walking with the Foot-up compared with walking with the
plastic AFO.
Study objective
The goal of this research is to discover if there is an improvement in the
walking ability when someone walks with the Foot-up compared to the plastic AFO
and walking without an AFO. The Timed up-and-go test will be used to look for
this improvement. Also the ROM of the ankle and the toe-clearance as well the
pushoff- (ipsilateral) and impact force (contralateral) and some
spatio-temporal parameters will be investigated. The subjective experience of
the subjects will also be investigated.
Study design
During the walk over the floor, where the footscan and forceplate are placed,
the groundreaction force and footpressure will be recorded. Also a high-speed
camera will make recordings of the foot and leg with reflecting markers on it.
All measurements will be done with a comfortable walking speed and subjects get
enough time to rest between the repeated masures. After every condition three
statements will be given and the TUG will be peformed two times . The subjects
must answer the statements with a nine points Likert scale. 1 will be "totally
disagree with that" and 9 will be "totally agree with that".
Intervention
Non-invasive gait analysis
Study burden and risks
Burden on the subjct will consist of 12 trials of walking on a walkway (20
meter) and 6 times performing the Timed Up-and-Go test with different AFO's on
an even surface at comfortable speed.
Subjects will have sufficient time for rest and practice.
Risk is very limited
van der Boechorststraat 9
1081 BT Amsterdam
Nederland
van der Boechorststraat 9
1081 BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
-Persons after stroke, walking on a conventional plastic anklefoot orthosis (AFO) without hinge to prevent a dropfoot
-minimal 6 months post-stroke
-age older than 18 years
-participants must be able to walk with shoes with shoe-laces
-The ability to walk at least four times a distance of 20 meters without EVO, four times with their plastic AFO and four times with the Foot-up, without the use of any other helps
-The ability to perform at least two times the Timed up-and-go test without EVO, two times with their plastic AFO and two times with the Foot-up, without the use of any other helps
Exclusion criteria
-Disabilities at the lower extremities (other than a dropfoot) or neurological disabilities, except a stroke, who can influence the gait pattern.
-Cognitive or mental disabilities who can influence the implementation of the task.
-Language disorders who can influence the understanding and answering of the quentionnaire.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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In other registers
Register | ID |
---|---|
CCMO | NL16790.029.07 |