Clinical trial NCT05279222: Window of Trainability in Relation to Surgical Correction of Foot Deformity
Official title: The Influence of Surgical Correction of Foot Deformity on the Effect of Gait Training on Gait Capacity in Chronic Stroke Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: Sint Maartenskliniek
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: 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.

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. Study population: Fifteen stroke patients with disabling foot deformity will be recruited from the Gait Expertise Center (LEC) of the Sint Maartenskliniek and Radboudumc.

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.

Main study parameters/endpoints: 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).


Eligibility criteria: Inclusion Criteria:

* \> 6 months post onset
* 18 years or older
* Functional Ambulation Classification (FAC) =\> 3: the patient is able to walk without physical support
* Will undergo a surgical correction of foot deformity

Exclusion Criteria:

* suffers from any other disorder that seriously affects gait capacity

Primary outcomes:
measure: Emory Functional Ambulation Profile score
timeFrame: 20 minutes
measure: Margin of Stability (MoS) (cm)
timeFrame: 30 minutes
measure: Timed-Up-And-Go test (TUG) score (s)
timeFrame: 1 minute
Secondary outcomes:
measure: Walking Adaptability Ladder Test score
timeFrame: 5 minutes
measure: Modified Dynamic Gait Index score
timeFrame: 20 minutes
measure: Lyapunov exponent (-)
timeFrame: 30 minutes
measure: Foot placement estimator (cm)
timeFrame: 30 minutes
measure: Distance between extrapolated center of mass (XCoM) and center of pressure (CoP) in anterior-posterior (AP) and medio-lateral (ML) direction (cm)
timeFrame: 30 minutes
measure: Center of mass (CoM) - center of pressure (CoP) inclination angles (degrees)
timeFrame: 30 minutes
measure: Step width variability (cm)
timeFrame: 30 minutes
measure: Step time variability (s)
timeFrame: 30 minutes
measure: Activities-specific Balance Confidence Scale (ABC Scale)
timeFrame: 10 minutes
measure: Walking speed (m/s)
timeFrame: 30 minutes
measure: Hip-knee-ankle-foot kinematics (degrees)
timeFrame: 30 minutes
measure: Peak ankle moment (Nm)
timeFrame: 30 minutes
measure: Peak ankle power (W)
timeFrame: 30 minutes
measure: Mini-BESTest score
timeFrame: 20 minutes
measure: Activity during the training sessions (minutes)
timeFrame: 1 minute
measure: Logbook training sessions (training excercises)
timeFrame: 15 minutes
measure: Step length (m)
timeFrame: 30 minutes
measure: Cadence (steps/minute)
timeFrame: 30 minutes
Other outcomes:
measure: Sex (man/ woman)
timeFrame: 0 minutes
measure: Age (years)
timeFrame: 0 minutes
measure: Height (cm)
timeFrame: 1 minute
measure: Weight (kg)
timeFrame: 1 minute
measure: Body Mass Index (BMI)
timeFrame: 0 minutes
Locations:
city: Nijmegen
country: Netherlands
facility: Netherlands
state: Gelderland
Study officials:
References: