Use of Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait

NCT06394635 | Completed

• 1 other identifier: 349c6c25d7a64a22
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

Stroke Patients with Genurecurvatum Gait

Stroke patients with genurecurvatum gait will be included.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stroke Patients with Genurecurvatum Gait

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27136122 BACKGROUND

• 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.

  PMID: 31871367 BACKGROUND

• 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.

  PMID: 34695721 BACKGROUND

Study Officials

• Süleyman Korkusuz, PhD

  Atılım University

  PRINCIPAL INVESTIGATOR

• Büşra Seçkinoğulları Korkusuz, MSc

  Hacettepe University

  STUDY CHAIR

• Ayşenur Özcan, MSc

  Çankırı Karatekin University

  STUDY CHAIR

• Ferdi Yavuz, Assoc.Prof.

  European University of Lefke

  STUDY CHAIR

• Nihat Özgören, PhD

  Hacettepe University

  STUDY CHAIR

• Serdar Arıtan, Assisst.Prof

  Hacettepe University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 1, 2024
• Study Start: May 15, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 20, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)