Chronic StrokeNCT06394635
Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait
An observational study of Chronic Stroke, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
Hypothesis 1: Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Chronic Stroke
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 20 Jul 2024
- 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 Genurecurvatum Gait
Who may be able to join
- At least 6 months have passed since the stroke incident
- Ambulating with or without a walking aid (walker, cane or tripod)
- Being between 0-3 points according to the Modified Rankin Scoring
- Getting a score of 24 or above from the Mini Mental Test
- Presence of hyperextension in the stance phase of gait
- Volunteering to participate in the study
Who cannot join
- Having a history of more than one stroke
- Known presence of dementia
- Having a known orthopedic, psychiatric or other neurological disease
- There is a situation that prevents communication
- Having a history of surgery involving the lower extremities and gait
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Using Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait
Hypothesis 1:
Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait.
Read more
H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on knee hyperextension control in stroke patients with genurecurvatum gait.
Hypothesis 2:
Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on pelvic movements in stroke patients with genurecurvatum gait.
H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on pelvic movements in stroke patients with genurecurvatum gait.
Read the detailed description
Kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. Patients will be asked to walk at a normal walking pace for a distance of only 5 meters. Patients will walk the 5-meter distance first without the Ankle-Foot Orthosis, then with the Ankle-Foot Orthosis adjusted at 3 degrees of dorsiflexion, and then with the Ankle-Foot Orthosis adjusted at 5 degrees of dorsiflexion.
- Conditions
- Chronic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Patients with Genurecurvatum Gait | Stroke patients with genurecurvatum gait will be included. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Analysis
Reflective signs will be placed on certain anatomical points on the participants and the participants will be asked to walk at a distance of 5 meters. The three-dimensional positions of these reflective signs will be captured with the 8-camera Vicon motion capture system and recorded on the computer using Blade software.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start15 May 2024
- Primary completion1 Jul 2024
- Study completion20 Jul 2024
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 Chronic 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suleyman Korkusuz, Hacettepe University
- Investigators
- Süleyman Korkusuz, PhD, Principal investigator, Atılım UniversityBüşra Seçkinoğulları Korkusuz, MSc, Study chair, Hacettepe UniversityAyşenur Özcan, MSc, Study chair, Çankırı Karatekin UniversityFerdi Yavuz, Assoc.Prof., Study chair, European University of LefkeNihat Özgören, PhD, Study chair, Hacettepe UniversitySerdar Arıtan, Assisst.Prof, Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394635
- Sponsor's protocol ID
- 349c6c25d7a64a22
- Status last verified
- Apr 2025
- First submitted
- 28 Apr 2024
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 27136122Bae 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 31871367Geerars 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Using Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait
- ClinicalTrials.gov ID
- NCT06394635
- Acronym / sponsor ID
- 349c6c25d7a64a22
- Conditions
- Chronic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 1 May 2024 (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.
Hypothesis 1:
Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on knee hyperextension control in stroke patients with genurecurvatum gait.
H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on knee hyperextension control in stroke patients with genurecurvatum gait.
Hypothesis 2:
Ho: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has no effect on pelvic movements in stroke patients with genurecurvatum gait.
H1: Ankle-foot orthosis, which fixes the ankle at different angles (3 degrees dorsiflexion - 5 degrees dorsiflexion), has an effect on pelvic movements in stroke patients with genurecurvatum gait.
Detailed description
Kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. Patients will be asked to walk at a normal walking pace for a distance of only 5 meters. Patients will walk the 5-meter distance first without the Ankle-Foot Orthosis, then with the Ankle-Foot Orthosis adjusted at 3 degrees of dorsiflexion, and then with the Ankle-Foot Orthosis adjusted at 5 degrees of dorsiflexion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Patients with Genurecurvatum Gait | – | –Stroke patients with genurecurvatum gait will be included. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke Patients with Genurecurvatum Gait
Key inclusion criteria (6 listed)
- At least 6 months have passed since the stroke incident
- Ambulating with or without a walking aid (walker, cane or tripod)
- Being between 0-3 points according to the Modified Rankin Scoring
- Getting a score of 24 or above from the Mini Mental Test
- Presence of hyperextension in the stance phase of gait
Key exclusion criteria (5 listed)
- Having a history of more than one stroke
- Known presence of dementia
- Having a known orthopedic, psychiatric or other neurological disease
- There is a situation that prevents communication
- Having a history of surgery involving the lower extremities and gait
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
Movement Analysis
Time frame: Baseline
Reflective signs will be placed on certain anatomical points on the participants and the participants will be asked to walk at a distance of 5 meters. The three-dimensional positions of these reflective signs will be captured with the 8-camera Vicon motion capture system and recorded on the computer using Blade software.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
- 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.
- 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 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.
- Individual participant dataSharing planned: No
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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.
Süleyman Korkusuz, PhD principal investigator
Atılım University
Büşra Seçkinoğulları Korkusuz, MSc study chair
Hacettepe University
Ayşenur Özcan, MSc study chair
Çankırı Karatekin 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 Chronic 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 6 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: finished, as of the sponsor's last update on 4 Apr 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Movement 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 NCT06394635, 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 4 Apr 2025.