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

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.

Completed

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Key information

Conditions

Chronic Stroke

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, Turkey (Türkiye)

About this study

Kinematic evaluation of the gaits of stroke patients in 3 different situations will be made in the motion analysis system. Patients will be asked to walk at a normal walking pace for a distance of only 5 meters. Patients will walk the 5-meter distance first without the Ankle-Foot Orthosis, then with the Ankle-Foot Orthosis adjusted at 3 degrees of dorsiflexion, and then with the Ankle-Foot Orthosis adjusted at 5 degrees of dorsiflexion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

Movement Analysis

Time frame: Baseline

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.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Investigation of the Effect of Using Plantar Flexion Resistant Ankle-Foot Orthosis in Stroke Patients With Genurecurvatum Gait

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: May 1, 2024
Registry last updated: Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed