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Window of Trainability in Relation to Surgical Correction of Foot Deformity

Primary Purpose

Stroke

Status
Withdrawn
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Gait adaptability training
Sponsored by
Sint Maartenskliniek
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Netherlands

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

gait training

Arm Description

Outcomes

Primary Outcome Measures

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.
Margin of Stability (MoS) (cm)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Timed-Up-And-Go test (TUG) score (s)
Measure for gait capacity.

Secondary Outcome Measures

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.
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.
Lyapunov exponent (-)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Foot placement estimator (cm)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
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.
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.
Step width variability (cm)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Step time variability (s)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Activities-specific Balance Confidence Scale (ABC Scale)
Measure for dynamic balance.
Walking speed (m/s)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Hip-knee-ankle-foot kinematics (degrees)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Peak ankle moment (Nm)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Peak ankle power (W)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Mini-BESTest score
Measure for gait capacity.
Activity during the training sessions (minutes)
Measured by the Polar A360 activity tracker.
Logbook training sessions (training excercises)
In the logbook, the therapist describes the exact tasks that are performed during the training sessions.
Step length (m)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Cadence (steps/minute)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.

Full Information

First Posted
February 4, 2022
Last Updated
October 25, 2022
Sponsor
Sint Maartenskliniek
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1. Study Identification

Unique Protocol Identification Number
NCT05279222
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled in the study within an inclusion period of 8 months
Study Start Date
April 1, 2022 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sint Maartenskliniek

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gait training
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Gait adaptability training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emory Functional Ambulation Profile score
Description
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.
Time Frame
20 minutes
Title
Margin of Stability (MoS) (cm)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Timed-Up-And-Go test (TUG) score (s)
Description
Measure for gait capacity.
Time Frame
1 minute
Secondary Outcome Measure Information:
Title
Walking Adaptability Ladder Test score
Description
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.
Time Frame
5 minutes
Title
Modified Dynamic Gait Index score
Description
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.
Time Frame
20 minutes
Title
Lyapunov exponent (-)
Description
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Foot placement estimator (cm)
Description
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Distance between extrapolated center of mass (XCoM) and center of pressure (CoP) in anterior-posterior (AP) and medio-lateral (ML) direction (cm)
Description
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Center of mass (CoM) - center of pressure (CoP) inclination angles (degrees)
Description
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Step width variability (cm)
Description
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Step time variability (s)
Description
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Activities-specific Balance Confidence Scale (ABC Scale)
Description
Measure for dynamic balance.
Time Frame
10 minutes
Title
Walking speed (m/s)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Hip-knee-ankle-foot kinematics (degrees)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Peak ankle moment (Nm)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Peak ankle power (W)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Mini-BESTest score
Description
Measure for gait capacity.
Time Frame
20 minutes
Title
Activity during the training sessions (minutes)
Description
Measured by the Polar A360 activity tracker.
Time Frame
1 minute
Title
Logbook training sessions (training excercises)
Description
In the logbook, the therapist describes the exact tasks that are performed during the training sessions.
Time Frame
15 minutes
Title
Step length (m)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Title
Cadence (steps/minute)
Description
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Time Frame
30 minutes
Other Pre-specified Outcome Measures:
Title
Sex (man/ woman)
Time Frame
0 minutes
Title
Age (years)
Time Frame
0 minutes
Title
Height (cm)
Time Frame
1 minute
Title
Weight (kg)
Time Frame
1 minute
Title
Body Mass Index (BMI)
Description
Calculated with the weight and height
Time Frame
0 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Netherlands
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6574NA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Window of Trainability in Relation to Surgical Correction of Foot Deformity

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