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

NCT ID: NCT05609461

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Chronic stroke patients with knee hyperextension

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atılım University

OTHER

Sponsor Role collaborator

Hacettepe University

OTHER

Sponsor Role lead

Responsible Party

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Suleyman Korkusuz

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kadriye Armutlu, Prof. Dr.

Role: STUDY_CHAIR

Hacettepe University

Süleyman Korkusuz, MSc

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Sibel Kibar, Assoc. Prof.

Role: STUDY_CHAIR

Atılım University

Serdar Arıtan, Asst.Prof

Role: STUDY_CHAIR

Hacettepe University

Nihat Özgören, MSc

Role: STUDY_CHAIR

Hacettepe University

Büşra Seçkinoğulları, Msc

Role: STUDY_CHAIR

Hacettepe University

Ayla Fil Balkan, Assoc.Prof

Role: STUDY_CHAIR

Hacettepe University

Locations

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Hacettepe University

Altındağ, Ankara, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 34695721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31871367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27136122 (View on PubMed)

Other Identifiers

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E-59394181-604.01.02-47710

Identifier Type: -

Identifier Source: org_study_id

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