Skip to main content
Clinical Trials/NCT05279222
NCT05279222
Withdrawn
Not Applicable

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

Sint Maartenskliniek1 site in 1 countryApril 1, 2022
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Sint Maartenskliniek
Locations
1
Primary Endpoint
Emory Functional Ambulation Profile score
Status
Withdrawn
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
May 1, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Emory Functional Ambulation Profile score

Time Frame: 20 minutes

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)

Time Frame: 30 minutes

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)

Time Frame: 1 minute

Measure for gait capacity.

Secondary Outcomes

  • Walking Adaptability Ladder Test score(5 minutes)
  • Modified Dynamic Gait Index score(20 minutes)
  • Lyapunov exponent (-)(30 minutes)
  • Foot placement estimator (cm)(30 minutes)
  • Distance between extrapolated center of mass (XCoM) and center of pressure (CoP) in anterior-posterior (AP) and medio-lateral (ML) direction (cm)(30 minutes)
  • Center of mass (CoM) - center of pressure (CoP) inclination angles (degrees)(30 minutes)
  • Step width variability (cm)(30 minutes)
  • Step time variability (s)(30 minutes)
  • Activities-specific Balance Confidence Scale (ABC Scale)(10 minutes)
  • Walking speed (m/s)(30 minutes)
  • Hip-knee-ankle-foot kinematics (degrees)(30 minutes)
  • Peak ankle moment (Nm)(30 minutes)
  • Peak ankle power (W)(30 minutes)
  • Mini-BESTest score(20 minutes)
  • Activity during the training sessions (minutes)(1 minute)
  • Logbook training sessions (training excercises)(15 minutes)
  • Step length (m)(30 minutes)
  • Cadence (steps/minute)(30 minutes)

Study Sites (1)

Loading locations...

Similar Trials