Window of Trainability in Relation to Surgical Correction of Foot Deformity

NCT05279222 | Withdrawn DMC

• 1 other identifier: 993_Pes_equinovarus_training
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• Timed-Up-And-Go test (TUG) score (s)

  Measure for gait capacity.

  1 minute

Secondary Outcomes (18)

• 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

Other Outcomes (5)

• Sex (man/ woman)

  0 minutes

• Age (years)

  0 minutes

• Height (cm)

  1 minute

Study Arms (1)

gait training

EXPERIMENTAL

Other: Gait adaptability training

Interventions

Gait adaptability training 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.

gait training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 6 months post onset
• 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

You may not qualify if:

• suffers from any other disorder that seriously affects gait capacity

Sponsors & Collaborators

• Sint Maartenskliniek: lead

Study Sites (1)

Netherlands

Nijmegen, Gelderland, 6574NA, Netherlands

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: March 15, 2022
• Study Start: April 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

NL (1)