The primary objective of this study is to evaluate the effect of surgical correction of pes equinovarus deformity compared to conservative treatment on personalized goal attainment. In addition, we will evaluate the effect of surgical correction of…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Health condition
Stroke patients with pes equinovarus deformity
Research involving
Sponsors and support
Intervention
- Surigical procedure
Outcome measures
Primary outcome
Concerning personalized goal attainment: - Canadian Occupational Performance Measure (COPM) Concerning gait capacity: - Timed-Up-And-Go test Concerning daily life gait performance: - Quantity: activity duration
Secondary outcome
Concerning gait capacity: - Self-selected gait speed - Cadence - Step length - Step-length symmetry - Single-support time - Single-support time symmetry - Hip-knee-ankle-foot kinematics - Peak ankle moment - Peak ankle power - Plantar pressure patterns - Mini-BESTest - Margin of Stability - Stepping error precision stepping Concerning daily life gait performance: - Quality: gait velocity - Quality: step length - Quality: cadence Other: - Surgical complications
Background summary
Acquired brain injury is the leading cause of disability in the western world. In patients with acquired brain injury, balance and gait impairments due to pes equinovarus deformity are common and disabling. It predisposes to hindfoot instability, reduced gait speed and distance, dependence on walking aids, pain while walking, and ultimately reduced functional mobility.
In the chronic phase after acquired brain injury, training does not improve pes equinovarus. Therefore, the emphasis of management should be on medical-technical interventions. Both nationally and internationally, however, there is relative underuse of surgical treatment options, although in our clinical experience this often has the best outcome.
In 2019, our group published a pilot observational study reporting a 30% increase in gait speed after surgical interventions. These preliminary results suggest surgical interventions for pes equinovarus deformity improve gait capacity in chronic stroke patients, and that the degree of improvement is of great clinical relevance. Further substantiation using clinical trials and a better understanding of the underlying mechanism is now needed.
Study objective
The primary objective of this study is to evaluate the effect of surgical correction of pes equinovarus deformity compared to conservative treatment on personalized goal attainment. In addition, we will evaluate the effect of surgical correction of pes equinovarus deformity on gait capacity and daily life gait performance.
Study design
Observational intervention study with repeated-measures. Additionally, a database that contains the measurements of people who have visited the Sint Maartenskliniek for routine clinical care will be analyzed in this study.
Intervention
Surgical correction of pes equinovarus deformity
Study burden and risks
There are no serious risks associated with participation in this study. Many measurements that will be performed in this study are already part of routine clinical care within the LEC. The additional measurements do not lead to increased risk, since appropriate safety measures will be taken such as wearing a safety harness to prevent falling during the regular walking task and while performing precision stepping and small perturbations in the Gait Real-time Analysis Interactive Lab (GRAIL).
The subjects will visit the clinic three times for performing measurements. Two visits are already part of routine clinical care. It is estimated that the measurements will take 5 hours in total in addition to the regular clinical treatment trajectory.
Age
Inclusion criteria
- > 6 Months post onset - 18 Years or older
Exclusion criteria
- Suffers from any other disorder that seriously affects gait capacity - Underwent a surgical intervention of the ankle/foot in the past two years
Design
Recruitment
IPD sharing statement
p/a Radboudumc, huispost 628,
Postbus 9101
6500 HB Nijmegen
024 361 3154
commissiemensgebondenonderzoek@radboudumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9696 |
CCMO | NL77992.091.21 |
OMON | NL-OMON54441 |