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

NCT05609461 | Withdrawn

• 1 other identifier: E-59394181-604.01.02-47710
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Gait Analysis; Foot-Ankle Orthosis; Knee Hyperextension; Kinematic Analysis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

Chronic stroke patients with knee hyperextension

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 Knee Hyperextension

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hacettepe University: lead
• Atılım University: collaborator

Study Sites (1)

Hacettepe University

Altındağ, Ankara, 06100, Turkey (Türkiye)

Location

Related Publications (3)

• 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

• 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

• 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kadriye Armutlu, Prof. Dr.

  Hacettepe University

  STUDY CHAIR

• Süleyman Korkusuz, MSc

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Sibel Kibar, Assoc. Prof.

  Atılım University

  STUDY CHAIR

• Serdar Arıtan, Asst.Prof

  Hacettepe University

  STUDY CHAIR

• Nihat Özgören, MSc

  Hacettepe University

  STUDY CHAIR

• Büşra Seçkinoğulları, Msc

  Hacettepe University

  STUDY CHAIR

• Ayla Fil Balkan, Assoc.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: November 1, 2022
• First Posted: November 8, 2022
• Study Start: October 25, 2022
• Primary Completion: June 1, 2023
• Study Completion: August 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)