Completed

Ankle Foot Orthosis for Stroke Rehabilitation

What is being tested

Exercise

Procedure

Who is being recruted

Brain Diseases+4

+ Cardiovascular Diseases

+ Central Nervous System Diseases

Over 18 Years

+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: February 2020

See protocol details

Summary

Principal SponsorAnkara Medipol University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: February 2, 2020

Actual date on which the first participant was enrolled.

This study investigates the effect of Ankle Foot Orthosis (AFO) on task-oriented treatment for individuals who have suffered a stroke. AFO is a device used to support the ankle and foot, which can help improve mobility and stability in people who have difficulty walking due to stroke. The study aims to determine if using this device can enhance the effectiveness of task-oriented therapy, which focuses on improving specific tasks and activities that patients struggle with post-stroke. Understanding the impact of AFO could lead to better rehabilitation strategies for stroke survivors, potentially improving their quality of life and independence. Participants in the study will use the Ankle Foot Orthosis device as part of their treatment. The study will observe how well participants perform specific tasks and activities that are typically challenging for stroke survivors. By measuring improvements in these tasks, researchers aim to evaluate the effectiveness of the AFO in combination with task-oriented therapy. This approach allows for a detailed assessment of how the device may contribute to recovery and rehabilitation, though the study does not mention specific risks or benefits associated with participation.

Official TitleThe Effect of Ankle Foot Orthesis on Task-oriented Treatment in Stroke

NCT06840132

Principal SponsorAnkara Medipol University

Last updated: January 28, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

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

Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesCerebrovascular DisordersNervous System DiseasesVascular DiseasesStroke

Criteria

6 inclusion criteria required to participate

Aged 18 and older,

Who had experienced their first stroke,

Brunnstrom lower extremity score of ≥3,

Functional Ambulation Classification score of ≥2,

Show More Criteria

2 exclusion criteria prevent from participating

Under 18 age,

Having an another neurologic disorder

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

patients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. For GoPT, a 7-station exercise protocol was designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Each station aimed to gradually improve the patient's motor abilities. Patients were allowed to rest between tasks, and the difficulty of the tasks progressively increased based on each patient's capacity. This 7-station protocol was designed for the first time by our own research team, and the details of the GoPT program

Group II

Active Comparator

patients participated in an intensive physical therapy program for 1 hour per day, 5 days a week, over a period of 4 weeks. group using plastic static ankle-foot orthoses (GoPT+AFO) performed the same 7-station exercise protocol as the GoPT group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises. Both the patients and their families were educated on the proper use of the orthosis and encouraged to wear it in daily life as well.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Ankara Medipol University

Ankara, Turkey (Türkiye)Open Ankara Medipol University in Google Maps

CompletedOne Study Center