- What are the effects of different types of ankle foot orthoses on weight-bearing and static and dynamic balance contribution of the paretic and non-paretic leg in stroke patients? - What are the effects of different types of ankle foot orthoses on…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters are
1) static balance contribution of the paretic and non-paretic leg;
2) dynamic balance contribution of the paretic and non-paretic leg;
3) functional (balance) tests.
Secondary outcome
not applicable
Background summary
An impaired balance control is a major problem in stroke patients. Ankle Foot
Orthoses (AFO) are generally prescribed to provide stability, even though the
literature is inconclusive about the effects of AFOs. In rehabilitation
improvement of weight-bearing symmetry is traditionally an important goal to
improve motor functioning and ADL independence. However, in earlier research
was found that the contribution of the paretic leg to balance was smaller than
the contribution of the paretic leg to weight-bearing. This led to the
conclusion that the contribution of the paretic leg to balance is not a
reflection of the weight distribution. This conclusion was based on
measurements while some patients wore an AFO, which may have influenced
postural balance and thus the results of the study. To further investigate the
effects of AFOs on balance performance in stroke patients a new research will
be conducted. In this research the effects of different types of AFOs on
weight-bearing and balance contribution of the paretic and non-paretic leg and
the effects on functional (balance) tests will be studied.
Study objective
- What are the effects of different types of ankle foot orthoses on
weight-bearing and static and dynamic balance contribution of the paretic and
non-paretic leg in stroke patients?
- What are the effects of different types of ankle foot orthoses on functional
(balance) tests?
Study design
A cross-over design with randomisation for standing with and without wearing
their own AFO on the affected leg will be used. Three groups of subjects with
different types of AFOs will be measured.
Intervention
Stroke patients with three different types of AFO will be included in this
study. All subjects will perform static and dynamic balance measurements on a
movable force platform, both with and without wearing their AFO, while wearing
their own shoes. Dynamic balance measurements consist of random, multisine
movements of the force platform in the forward-backward direction (1 dimension)
of maximal 5 cm. Subjects will also perform functional (balance) tests with and
without wearing their AFO. To further categorise the three subject groups ankle
stiffness, ankle spasticity, selective muscle control and trunk movements will
be measured.
Study burden and risks
During the study subjects will be measured two times. The first time will be in
the VR lab to measure weight-bearing and static and dynamic balance
contribution of the paretic and non-paretic leg. The second time will be in the
gait lab for functional (balance) tests. Subjects might lose their equilibrium
during the measurements. Therefore a safety harness suspended from the ceiling
will be used when subjects stand on the force platform in the VR lab to prevent
falling. During all the measurements an experienced physiotherapist will
accompany the subjects.
Roessinghsbleekweg 33b
7522AH Enschede
Nederland
Roessinghsbleekweg 33b
7522AH Enschede
Nederland
Listed location countries
Age
Inclusion criteria
- single and first ever unilateral ischaemic or haemorrhagic hemiparetic stroke
- age 18 years or older
- wearing an AFO daily for at least six months of one of the three included types
- able to maintain independent unsupported stance with shoes on, with and without wearing an AFO on the affected side, for at least 90 seconds
- able to walk for 10 m with or without assisted device
- able to follow simple verbal command or instructions
Exclusion criteria
- medication or non-stroke related disorders that could affect balance
- suffering from comprehensive aphasia
- suffering from neglect
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 | NL16299.080.07 |