Objective: The aims of this study are to explore the effects of foot and ankle surgery on the equinovarus foot deformity of patients after stroke in terms of foot function, walking abilities and social participation. Furthermore, the relationships…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters includes the effect of surgery on restoring foot and
ankle kinematics (motion).
Secondary outcome
Furthermore, the effects of surgery on walking ability such as walking speed
and endurance and fall risk, as well as daily participation measures is
assessed.
Background summary
Rationale: Equinovarus is the most frequently seen foot deformity in the
affected leg after stroke and compromises the patient*s walking ability and
participation in daily life. Surgical intervention is a promising therapy since
it enables the patient to walk more independently, barefoot, without the need
of an orthosis. However, the effects of the foot and ankle surgery on restoring
foot and ankle kinematics and kinetics, walking ability and on quality of life
are not or not extensively studied.
Study objective
Objective: The aims of this study are to explore the effects of foot and ankle
surgery on the equinovarus foot deformity of patients after stroke in terms of
foot function, walking abilities and social participation. Furthermore, the
relationships between pre-surgical factors (function) and improvements in
activity and participation will be studied.
Study design
Study design: This study has an exploratory design with two measurement
sessions of one day each: one in the period before and the other 6 months after
foot and ankle surgery. If this is impossible for the participant, only the
questionnaires can be filled in at home. The intervention consists of standard
techniques applied in soft-tissue surgery of equinovarus foot deformities.
Study burden and risks
The risks for the subjects are limited, since the tasks represent functional
and familiar movements and are performed within a safe environment. When
fatigue occurs, the subjects are able to rest till recovered. Furthermore, a
therapist may walk along with the subject in cases necessary or requested. In
addition, most measurements used in this study are non-invasive and involve no
risks to the subjects in any way. The only invasive measure is performed
according to standard clinical procedures.
Participation of a subject in this experiment has no direct benefit for
him/her, other than expanding knowledge about the effects of foot and ankle
equinovarus surgery on restoring foot and ankle function and walking ability.
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Roessinghsbleekweg 33b
Enschede 7522 AH
NL
Listed location countries
Age
Inclusion criteria
1. Unilateral ischaemic or haemorrhagic hemiparetic stroke
2. Time since stroke > 6 months
3. Age 18 years or older
4. Walking disabilities and/or fall incidents and/or pressure sores on the foot
and/or unable to walk bare foot due to structural or dynamic equinovarus foot
deformity, including
a. problems with stability in stance
b. problems with foot clearance during swing
c. problems with foot prepositioning in early stance
5. Subject is selected for surgical correction of equinovarus foot only (so no
intervention to structures around knee that may influence gait)
6. Subject is able to participate in an 1.5 hour session, including several
stand and walking activities (walking aids allowed) with breaks in-between
Exclusion criteria
1. Complicating medical history such as cardiac, pulmonary, neurological or
orthopaedic disorders that could severely affect performance of the included
measurements
2. Neurolysis (fenol/alcohol) < 8 months
3. Motorpoint blockage (btx) < 5 months
4. Suffering from severe neglect
5. Severe comprehensive aphasia
6. Severe cognitive disorders
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 |
|---|---|
| Other | Nederlands trial register |
| CCMO | NL58628.044.16 |