Clinical trial NCT06394635: Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait
Official title: Investigation of the Effect of Using Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Stroke
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 34
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 Genurecurvatum Gait

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Movement Analysis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacettepe University
Study officials:
affiliation: Atılım University
name: Süleyman Korkusuz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Büşra Seçkinoğulları Korkusuz, MSc
role: STUDY_CHAIR
affiliation: Çankırı Karatekin University
name: Ayşenur Özcan, MSc
role: STUDY_CHAIR
affiliation: European University of Lefke
name: Ferdi Yavuz, Assoc.Prof.
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Nihat Özgören, PhD
role: STUDY_CHAIR
affiliation: Hacettepe University
name: Serdar Arıtan, Assisst.Prof
role: STUDY_CHAIR
References:
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.
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: 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.