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

March 4, 2025 updated by: Sezen Dincer, Ankara Medipol University

A stroke is a neurological condition and a major cause of disability in adults. It occurs suddenly and causes specific brain function problems, leading to noticeable symptoms that last for more than 24 hours.Stroke commonly causes impairments in sensory, motor, and cognitive functions. Approximately 80% of patients experience motor deficits in the lower extremities, often accompanied by balance disturbance (3). Traditionally, neurodevelopmental treatments aimed at restoring normal movement patterns have been used in stroke rehabilitation. However, research on both animals and humans has shown that this approach alone is insufficient. These studies have shown that task-oriented functional exercise training can induce changes in activation patterns in a large portion of the damaged brain areas, leading to restoration of function (4, 5). Engaging in meaningful and repetitive goal-directed functional tasks can effectively enhance neuroplasticity and facilitate recovery.

Task-oriented training is an exercise therapy designed for stroke patients, based on motor learning theory, which emphasizes the repetition of motor skills and aims to enhance performance through meaningful tasks . Lord et al. were the first researchers to conceptually apply task-oriented training, using a total of 19 different functional exercises in their study. They found that both deficiency-based and task-oriented training showed similar results in terms of improving walking and balance skills. However, more recent studies have shown that task-specific, task-oriented treatment programs are superior to traditional facilitation-based therapeutic approaches. Another study comparing conventional physiotherapy, task-oriented group training, and individual task-oriented training, with the aim of assessing the effects of exercises, demonstrated that task-oriented group training led to better outcomes in tasks such as sitting, standing, overcoming obstacles, circular walking, and carrying objects.

Two others found that the foot was more dorsiflexed at higher stiffnesses during initial contact in patients post- stroke An Ankle-Foot Orthosis (AFO) plays a crucial role in individuals with paralysis during walking, particularly in the heel strike and loading phases, by restraining plantar flexion and assisting the impaired function of the dorsiflexors. In individuals with paralysis, dorsiflexion, the upward movement of the ankle, is often weakened or lost. The AFO helps address this issue by maintaining the desired position of the ankle joint, contributing to the preservation of normal gait during walking.

Additionally, during the swing phase (when the leg moves forward), the AFO helps maintain the ankle joint position, supporting toe-off. This enhances walking efficiency and provides stability during the step. Thus, the AFO not only offers support but also significantly contributes to functional improvement, greatly enhancing the walking ability of individuals with paralysis.

Combined use of task-oriented training and orthoses are typically focused on the upper extremity functions rather than the lower extremity functions in patients with stroke. Therefore, in this study, it was aimed to investigate the effects of task-oriented training with and without an ankle-foot orthosis (AFO) on lower extremity function in individuals with stroke. It was hypothesized that task-oriented training with an AFO would lead to greater improvements in lower extremity function such as balance, walking, and stability and quality of life in stroke patients.

The study included 40 individuals with stroke. The inclusion criteria of the study were as follows: aged 18 and older, who had experienced their first stroke, Brunnstrom lower extremity score of ≥3, a Functional Ambulation Classification score of ≥2, at least 3 months post-stroke, and having no other neurological disorders. The individuals will be diagnosed at the Physical Therapy and Rehabilitation outpatient clinic of Balıkesir Atatürk City Hospital by the same neurologist and received treatment at the hospital's rehabilitation department.All 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 designed, consisting of motor activities progressing from easy to difficult, with the goal of transforming these activities into permanent skills through meaningful tasks. Participants randomly divided into two groups: the task-oriented physical therapy group (GoPT) (n=19), the task-oriented program plus plastic static ankle-foot orthosis group (GoPT+AFO) (n=20). All participants in the groups were evaluated by a physiotherapist before treatment and after the 4-week intervention period.Six-Minute Walk Test, 10-Meter Walk Test,Timed Up and Go Test,Berg Balance Scale, Functional Reach Test,Stroke Impact Scale were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Before starting the study, an application was made to Balıkesir University Non-Interventional Clinical Research Ethics Committee. Usage started with the permission of the ethics committee, decision dated 13.12.2017 and 2017/156.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Turkey
      • Ankara, Turkey, 06100
        • Ankara Medipol 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18 and older,
  • Who had experienced their first stroke,
  • Brunnstrom lower extremity score of ≥3,
  • Functional Ambulation Classification score of ≥2,
  • At least 3 months post-stroke,
  • Having no other neurological disorders

Exclusion Criteria:

  • Under 18 age,
  • Having an another neurologic disorder

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the task-oriented training
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
Procedure: Exercise
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
Other Names:
  • task oriented exercise therapy
Procedure: Exercise
In addition to the task-oriented training program, the group using plastic static ankle-foot orthoses performed the same 7-station exercise protocol as the task oriented training group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises.
Other Names:
  • task oriented training + orthoses
Active Comparator: the task-oriented training plus plastic static ankle-foot orthosis group
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.
Procedure: Exercise
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
Other Names:
  • task oriented exercise therapy
Procedure: Exercise
In addition to the task-oriented training program, the group using plastic static ankle-foot orthoses performed the same 7-station exercise protocol as the task oriented training group. However, participants in this group were required to wear custom-made plastic static ankle-foot orthoses while completing the exercises.
Other Names:
  • task oriented training + orthoses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
six meter walk
Time Frame: from enrollement to the end of four weeks
endurance test. It is assessed by having the person walk continuously for 6 minutes at the maximum speed they can walk in a 30-meter area. The distance walked during this time is recorded. Increased walking distance is perceived positively
from enrollement to the end of four weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
berg balance scale
Time Frame: from enrollement to the end of 4 weeks
balance evaluation. Each activity is given a score between 0-4. The best score is 56. 0-20 is interpreted as poor balance, 21-40 as acceptable balance, and 41-56 as advanced balance skills.
from enrollement to the end of 4 weeks

Collaborators and Investigators

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

Sponsor

Ankara Medipol University

Collaborators

Balikesir Ataturk City Hospital

Investigators

  • Principal Investigator: sezen dincer, asst prof, ankara medipol univercity

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)

February 2, 2020

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 18, 2025

First Submitted That Met QC Criteria

February 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Balıkesir Atatürk CityHospital

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

product manufactured in and exported from the U.S.

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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