StrokeNCT05279222
Window of Trainability in Relation to Surgical Correction of Foot Deformity
A study testing Gait adaptability training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Gait adaptability training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Apr 2022to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- suffers from any other disorder that seriously affects gait capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Surgical Correction of Foot Deformity on the Effect of Gait Training on Gait Capacity in Chronic Stroke Patients
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.
Read more
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
- Being tested
- Gait adaptability training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gait adaptability trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| gait training | Experimental | Not described Receives: Other: Gait adaptability training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 minutes
Timed-Up-And-Go test (TUG) score (s)
Measure for gait capacity.
Measured: 1 minute
Secondary outcomes (18)
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.
Measured: 5 minutes
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.
Measured: 20 minutes
Lyapunov exponent (-)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Foot placement estimator (cm)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
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.
Measured: 30 minutes
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.
Measured: 30 minutes
Step width variability (cm)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Step time variability (s)
Measure for dynamic balance. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Activities-specific Balance Confidence Scale (ABC Scale)
Measure for dynamic balance.
Measured: 10 minutes
Walking speed (m/s)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Hip-knee-ankle-foot kinematics (degrees)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Peak ankle moment (Nm)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Peak ankle power (W)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Mini-BESTest score
Measure for gait capacity.
Measured: 20 minutes
Activity during the training sessions (minutes)
Measured by the Polar A360 activity tracker.
Measured: 1 minute
Logbook training sessions (training excercises)
In the logbook, the therapist describes the exact tasks that are performed during the training sessions.
Measured: 15 minutes
Step length (m)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Cadence (steps/minute)
Measure for gait capacity. Measured by using the Gait Real Time Analysis Interactive Lab as a measurement device.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: No participants were enrolled in the study within an inclusion period of 8 months
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sint Maartenskliniek
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279222
- Sponsor's protocol ID
- 993_Pes_equinovarus_training
- Status last verified
- Oct 2022
- First submitted
- 4 Feb 2022
- Last updated
- 28 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Surgical Correction of Foot Deformity on the Effect of Gait Training on Gait Capacity in Chronic Stroke Patients
- ClinicalTrials.gov ID
- NCT05279222
- Acronym / sponsor ID
- 993_Pes_equinovarus_training
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled in the study within an inclusion period of 8 months
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sint MaartenskliniekUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gait training | Experimental | Other: Gait adaptability training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 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
Key exclusion criteria (1 listed)
- suffers from any other disorder that seriously affects gait capacity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gait adaptability trainingAll 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. | Other | gait training |
Primary outcome
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.
18 secondary outcomes
Walking Adaptability Ladder Test score
Time frame: 5 minutes
Modified Dynamic Gait Index score
Time frame: 20 minutes
Lyapunov exponent (-)
Time frame: 30 minutes
Foot placement estimator (cm)
Time frame: 30 minutes
Distance between extrapolated center of mass (XCoM) and center of pressure (CoP) in anterior-posterior (AP) and medio-lateral (ML) direction (cm)
Time frame: 30 minutes
Center of mass (CoM) - center of pressure (CoP) inclination angles (degrees)
Time frame: 30 minutes
Step width variability (cm)
Time frame: 30 minutes
Step time variability (s)
Time frame: 30 minutes
Activities-specific Balance Confidence Scale (ABC Scale)
Time frame: 10 minutes
Walking speed (m/s)
Time frame: 30 minutes
Hip-knee-ankle-foot kinematics (degrees)
Time frame: 30 minutes
Peak ankle moment (Nm)
Time frame: 30 minutes
Peak ankle power (W)
Time frame: 30 minutes
Mini-BESTest score
Time frame: 20 minutes
Activity during the training sessions (minutes)
Time frame: 1 minute
Logbook training sessions (training excercises)
Time frame: 15 minutes
Step length (m)
Time frame: 30 minutes
Cadence (steps/minute)
Time frame: 30 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait adaptability training in people with Stroke, run by Sint Maartenskliniek at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emory Functional Ambulation Profile score (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2022.