Window of Trainability in Relation to Surgical Correction of Foot Deformity

Stroke Clinical Trial

Official title:

The Influence of Surgical Correction of Foot Deformity on the Effect of Gait Training on Gait Capacity in Chronic Stroke Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05279222
• Other study ID #: 993_Pes_equinovarus_training
• Status: Withdrawn
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2022
• Source: Sint Maartenskliniek
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Foot Deformities
• Stroke

Intervention

Other:
• Gait adaptability training
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.

Locations

Country	Name	City	State
Netherlands	Netherlands	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Sint Maartenskliniek

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex (man/ woman)		0 minutes
Other	Age (years)		0 minutes
Other	Height (cm)		1 minute
Other	Weight (kg)		1 minute
Other	Body Mass Index (BMI)	Calculated with the weight and height	0 minutes
Primary	Emory Functional Ambulation Profile score	Measure for gait adaptability. The E-FAP consists of five subtasks: a 5-meter walk test on a hard-surfaced floor, a 5-meter walk test on a carpeted floor, an up and go task, an obstacle course, and ascent and descent of four stairs. The subtasks will be completed according to the sequence above and the time it takes to complete each subtask will be recorded. A standardized E-FAP protocol will be used to assess the subtasks of the E-FAP.	20 minutes
Primary	Margin of Stability (MoS) (cm)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Primary	Timed-Up-And-Go test (TUG) score (s)	Measure for gait capacity.	1 minute
Secondary	Walking Adaptability Ladder Test score	Measure for gait adaptability. For this test, a standardized ladder is placed on the floor. It consists of 17 rectangular stepping targets that gradually decrease 2 cm in length (range 64-32 cm). Participants start stepping in the largest target and walk as fast as possible to the other side, turn and hit the targets in reverse order while avoiding the ladder rungs. The instructions are to perform the test as fast as possible, without making foot placement errors. The test is timed: a faster time is indicative of a better gait adaptability. Participants perform the test four times, first twice with one foot per target and, thereafter, twice with both feet in one target. A time penalty of 0.5 s is added each time a participant makes a foot placement mistake.	5 minutes
Secondary	Modified Dynamic Gait Index score	Measure for gait adaptability. The modified Dynamic Gait Index consists of 8 subtasks: usual pace, change pace, horizontal head turns, vertical head turns, pivot turn, stepping over obstacles, stepping around obstacles and stairs. The subtasks will be performed according to the mDIG protocol. The time to complete each subtask will be recorded and used as outcome measure.	20 minutes
Secondary	Lyapunov exponent (-)	Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Foot placement estimator (cm)	Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Distance between extrapolated center of mass (XCoM) and center of pressure (CoP) in anterior-posterior (AP) and medio-lateral (ML) direction (cm)	Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Center of mass (CoM) - center of pressure (CoP) inclination angles (degrees)	Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Step width variability (cm)	Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Step time variability (s)	Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Activities-specific Balance Confidence Scale (ABC Scale)	Measure for dynamic balance.	10 minutes
Secondary	Walking speed (m/s)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Hip-knee-ankle-foot kinematics (degrees)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Peak ankle moment (Nm)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Peak ankle power (W)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Mini-BESTest score	Measure for gait capacity.	20 minutes
Secondary	Activity during the training sessions (minutes)	Measured by the Polar A360 activity tracker.	1 minute
Secondary	Logbook training sessions (training excercises)	In the logbook, the therapist describes the exact tasks that are performed during the training sessions.	15 minutes
Secondary	Step length (m)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes
Secondary	Cadence (steps/minute)	Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.	30 minutes