Clinical trial NCT05609461: Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients
Official title: Investigation of the Effect of Orthosis Use for Control of Knee Hyperextension in Chronic Stroke Patients by Kinematic Analysis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Stroke
Keywords: Gait Analysis
Foot-Ankle Orthosis
Knee Hyperextension
Kinematic Analysis
Lead sponsor: Hacettepe University
Sponsor class: OTHER
Collaborators: name: Atılım University
First posted: 2022-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stroke Patients with Knee Hyperextension

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Kinematic Analysis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Altındağ
country: Turkey
facility: Hacettepe University
state: Ankara
Study officials:
affiliation: Hacettepe University
name: Kadriye Armutlu, Prof. Dr.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Süleyman Korkusuz, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Atılım University
name: Sibel Kibar, Assoc. Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Serdar Arıtan, Asst.Prof
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Nihat Özgören, MSc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Büşra Seçkinoğulları, Msc
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Ayla Fil Balkan, Assoc.Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.