StrokeNCT05609461

Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients

An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

The aim of this study is to examine the effect of using foot-ankle orthosis at different angles on hyperextension control in stroke patients. The hypotheses of the study are: Hypothesis 1: Ho: The foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in… Read more about this study

Who is it for?: Ages 40 to 65 years
Conditions the study is for: Stroke
How many people: 0 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 25 Oct 2022to Aug 2023
Phase: Observational
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 40 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Stroke Patients with Knee Hyperextension

Who may be able to join

Between the ages of 40 and 65
Six months must have passed since the stroke.
Ambulation regardless of the use of a walking aid (walker, cane, or tripod)
Obtaining between 0 and 3 Modified Rankin Score points
A score of 24 or higher on the Mini Mental Test is required to pass.
Hyperextension during the stance phase of gait.
Participating voluntarily in the study

Who cannot join

Having a history of more than one stroke
Dementia is known to exist
Having a diagnosed orthopedic, mental, or neurological condition
Having a circumstance that impedes communication
Having a history of lower extremity and gait-related surgeries

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Hacettepe University
Altındağ, Ankara, 06100

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients by Kinematic Analysis

The aim of this study is to examine the effect of using foot-ankle orthosis at different angles on hyperextension control in stroke patients.

The hypotheses of the study are:

Hypothesis 1:

Ho: The foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has no effect on the control of knee hyperextension.

H1: Foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has an effect on the control of knee hyperextension.

Conditions: Stroke
Keywords: Gait Analysis, Foot-Ankle Orthosis, Knee Hyperextension, Kinematic Analysis
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05609461
Study group	Role	What they receive
Chronic stroke patients with knee hyperextension		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Kinematic Analysis
At the specified anatomical sites of the participants, reflective signs will be placed. The participants will be required to walk 5 meters. The three-dimensional positions of these reflective marks will be captured by the 8-camera Vicon motion capture system. Using the blade software, it will be moved to the computer environment and kinematic data will be collected.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Oct 2022Aug 2023

First posted8 Nov 2022
Study start25 Oct 2022
Primary completionJun 2023 (estimated)
Study completionAug 2023 (estimated)

Why it stopped: Necessary equipment could not be provided.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
More trials run by Hacettepe UniversityThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05609461
Sponsor's protocol ID: E-59394181-604.01.02-47710
Status last verified: Jun 2023
First submitted: 1 Nov 2022
Last updated: 22 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Geerars M, Minnaar-van der Feen N, Huisstede BMA. Treatment of knee hyperextension in post-stroke gait. A systematic review. Gait Posture. 2022 Jan;91:137-148. doi: 10.1016/j.gaitpost.2021.08.016. Epub 2021 Aug 24.
PubMed 34695721
Bae DY, Shin JH, Kim JS. Effects of dorsiflexor functional electrical stimulation compared to an ankle/foot orthosis on stroke-related genu recurvatum gait. J Phys Ther Sci. 2019 Nov;31(11):865-868. doi: 10.1589/jpts.31.865. Epub 2019 Nov 26.
PubMed 31871367
Kobayashi T, Orendurff MS, Singer ML, Gao F, Daly WK, Foreman KB. Reduction of genu recurvatum through adjustment of plantarflexion resistance of an articulated ankle-foot orthosis in individuals post-stroke. Clin Biomech (Bristol). 2016 Jun;35:81-5. doi: 10.1016/j.clinbiomech.2016.04.011. Epub 2016 Apr 23.
PubMed 27136122

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients by Kinematic Analysis
ClinicalTrials.gov ID: NCT05609461
Acronym / sponsor ID: E-59394181-604.01.02-47710
Conditions: Stroke
Keywords: Gait Analysis, Foot-Ankle Orthosis, Knee Hyperextension, Kinematic Analysis
Study type: Observational
Recruitment status: WithdrawnReason stopped: Necessary equipment could not be provided.
Enrolment: 0 participants (actual)
Lead sponsor: Hacettepe UniversityUniversity, hospital or other
Collaborators: Atılım University
Study start: 25 Oct 2022 (actual)
Primary completion: Jun 2023 (estimated)
Study completion: Aug 2023 (estimated)
First posted: 8 Nov 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.

The aim of this study is to examine the effect of using foot-ankle orthosis at different angles on hyperextension control in stroke patients.

The hypotheses of the study are:

Hypothesis 1:

Ho: The foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has no effect on the control of knee hyperextension.

H1: Foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has an effect on the control of knee hyperextension.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Chronic stroke patients with knee hyperextension	–	–

Who may qualify

Ages: 40 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Stroke Patients with Knee Hyperextension

Key inclusion criteria (7 listed)

Between the ages of 40 and 65
Six months must have passed since the stroke.
Ambulation regardless of the use of a walking aid (walker, cane, or tripod)
Obtaining between 0 and 3 Modified Rankin Score points
A score of 24 or higher on the Mini Mental Test is required to pass.

Key exclusion criteria (5 listed)

Having a history of more than one stroke
Dementia is known to exist
Having a diagnosed orthopedic, mental, or neurological condition
Having a circumstance that impedes communication
Having a history of lower extremity and gait-related surgeries

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Kinematic Analysis
Time frame: Baseline
At the specified anatomical sites of the participants, reflective signs will be placed. The participants will be required to walk 5 meters. The three-dimensional positions of these reflective marks will be captured by the 8-camera Vicon motion capture system. Using the blade software, it will be moved to the computer environment and kinematic data will be collected.

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 22 Jun 2023.
Background: PubMed 34695721Geerars M, Minnaar-van der Feen N, Huisstede BMA. Treatment of knee hyperextension in post-stroke gait. A systematic review. Gait Posture. 2022 Jan;91:137-148. doi: 10.1016/j.gaitpost.2021.08.016. Epub 2021 Aug 24.
Background: PubMed 31871367Bae DY, Shin JH, Kim JS. Effects of dorsiflexor functional electrical stimulation compared to an ankle/foot orthosis on stroke-related genu recurvatum gait. J Phys Ther Sci. 2019 Nov;31(11):865-868. doi: 10.1589/jpts.31.865. Epub 2019 Nov 26.
Background: PubMed 27136122Kobayashi T, Orendurff MS, Singer ML, Gao F, Daly WK, Foreman KB. Reduction of genu recurvatum through adjustment of plantarflexion resistance of an articulated ankle-foot orthosis in individuals post-stroke. Clin Biomech (Bristol). 2016 Jun;35:81-5. doi: 10.1016/j.clinbiomech.2016.04.011. Epub 2016 Apr 23.
Individual participant dataSharing planned: No

Related trials for Stroke

Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion

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.

Kadriye Armutlu, Prof. Dr. study chair

Hacettepe University

Süleyman Korkusuz, MSc principal investigator

Hacettepe University

Sibel Kibar, Assoc. Prof. study chair

Atılım University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).

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 7 inclusion and 5 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 22 Jun 2023. 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 Turkey (Türkiye). 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?

Kinematic Analysis (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609461, which also lists 3 linked publications.

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 22 Jun 2023.