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

June 18, 2023 updated by: Suleyman Korkusuz, Hacettepe University

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

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.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
    • Ankara
      • Altındağ, Ankara, Turkey, 06100
        • Hacettepe University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Stroke Patients with Knee Hyperextension

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Chronic stroke patients with knee hyperextension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Kinematic Analysis
Time Frame: Baseline
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Collaborators

Atılım University

Investigators

  • Study Chair: Kadriye Armutlu, Prof. Dr., Hacettepe University
  • Study Chair: Büşra Seçkinoğulları, MSc, Hacettepe University
  • Study Chair: Sibel Kibar, Assoc. Prof., Atılım University
  • Study Chair: Serdar Arıtan, Asst.Prof, Hacettepe University
  • Study Chair: Nihat Özgören, MSc, Hacettepe University
  • Principal Investigator: Süleyman Korkusuz, MSc, Hacettepe University
  • Study Chair: Ayla Fil Balkan, Assoc.Prof, Hacettepe University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Estimated)

June 1, 2023

Study Completion (Estimated)

August 1, 2023

Study Registration Dates

First Submitted

November 1, 2022

First Submitted That Met QC Criteria

November 1, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 18, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-59394181-604.01.02-47710

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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