The primary objective of this study is to compare the effect of gait training on gait capacity (stepping performance, gait adaptability and dynamic balance) before and after surgical correction of post-stroke foot deformity.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes will be gait adaptability as measured with the Emory Function
Ambulation Profile (E-FAP), stepping performance as measured with the
Timed-Up-And-Go test (TUG) and dynamic balance as measured with the Margin of
Stability (MoS).
Secondary outcome
Concerning gait adaptability:
- Walking Adaptability Ladder Test (WALT)
- Modified Dynamic Gait Index (mDIG)
Concerning dynamic balance:
- Lyapunov exponent
- Foot placement estimator
- Distance between extrapolated center of mass (XCoM) and center of pressure
(CoP) in anterior-posterior (AP) and medio-lateral (ML) direction
- Center of mass (CoM) - center of pressure (CoP) inclination angles
- Step width variability
- Step time variability
- Activities-specific Balance Confidence Scale (ABC Scale)
Concerning stepping performance:
- Spatiotemporal gait parameters
- Hip-knee-ankle-foot kinematics
- Peak ankle moment
- Peak ankle power
- Mini-BESTest
Other
- Activity during the training sessions
- Logbook training sessions
Background summary
Stroke is the leading cause of disability in the western world. In chronic
stroke patients, foot deformity such as pes equinovarus is among the most
important underlying motor deficits, due to imbalance of muscle strength and
activity around the ankle and tarsal joints.
Both nationally and internationally, there is relative underuse of surgical
treatment options, although in our clinical experience this often has the best
outcome. In addition to positive clinical experiences with surgical
interventions, we have experienced that before surgery, there is limited effect
of gait training on gait capacity. However, we have experienced that after
surgery, the restored normal ankle-foot position creates a new window for
training opportunities to further improve gait capacity. Therefore, in this
exploratory proof of principle study we aim to investigate the effect of
surgical correction of post-stroke foot deformity on the (potential)
improvement of gait capacity after gait training. Based on clinical
experiences, we expect that after surgery, gait training results in a larger
improvement in gait capacity compared to before the surgical intervention due
to the increased possibilities to improve balance control.
Study objective
The primary objective of this study is to compare the effect of gait training
on gait capacity (stepping performance, gait adaptability and dynamic balance)
before and after surgical correction of post-stroke foot deformity.
Study design
Exploratory proof of principle study with repeated-measures.
Intervention
All patients will receive two gait training interventions, each consisting of
twelve one hour training sessions. The training sessions will be focussed on
improving gait capacity.
Study burden and risks
There are no serious risks associated with participating in this study. All
training sessions will be given by experienced physiotherapists and the
difficulty of the training sessions will be adjusted based on the patient*s
capacity and performance. Furthermore, appropriate safety precautions will be
taken during the training sessions when needed. For the measurement in the Gait
Real-time Analysis Interactive Lab (GRAIL), the risk is also estimated as
negligible, since the measurements will be performed by experienced and
certified GRAIL operators. Moreover, patients will wear a safety harness to
prevent falling. The assessment of the overground gait capacity outcomes will
also be performed by experienced therapists and researchers. In addition,
appropriate safety measures will be taken when necessary, such as therapists
that are walking next to the patient to prevent falling.
The gait capacity training program will take place at the Sint Maartenskliniek
in Nijmegen and consists of twelve training sessions of one hour per training
session. Each patient will participate twice in the training program. Before
and after each training program, measurements will be performed. The
measurements will take approximately two hours. Hence, it will take the
participants approximately 32 hours to participate in this study, excluding
travel time.
Niek Engelschmanlaan 128
Nijmegen 6532CT
NL
Niek Engelschmanlaan 128
Nijmegen 6532CT
NL
Listed location countries
Age
Inclusion criteria
- Stroke patients with ankle-foot deformity
- > 6 months post onset
- 18 years or older
- Functional Ambulation Classification (FAC) => 3: the patient is able to walk
without physical support
Exclusion criteria
- suffers from any other disorder that seriously affects gait capacity
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 | NL78999.091.21 |