Window of Trainability in Relation to Surgical Correction of Foot Deformity

NCT ID: NCT05279222

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-05-01

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).

Conditions

Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

gait training

Group Type: EXPERIMENTAL

Gait adaptability training

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sint Maartenskliniek

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Netherlands

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

993_Pes_equinovarus_training

Identifier Type: -

Identifier Source: org_study_id