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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05609461
• Other study ID #: E-59394181-604.01.02-47710
• Status: Withdrawn
• Start date: October 25, 2022
• Est. completion date: August 2023

Study information

• Verified date: June 2023
• Source: Hacettepe University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
Turkey	Hacettepe University	Altindag	Ankara

Sponsors (2)

Lead Sponsor	Collaborator
Hacettepe University	Atilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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, Avon). 2016 Jun;35:81-5. doi: 10.1016/j.clinbiomech.2016.04.011. Epub 2016 Apr 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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