The Effect of Ankle Foot Orthosis Influences the Prefrontal Load in Stroke Patients During Dual Task Walking

March 25, 2026 updated by: Yi-Ying Tsai, National Cheng-Kung University Hospital

The goal of this clinical trial is to learn the effect of carbon fiber ankle foot rothosis (AFO) on dual-task walking perfromance and cognitive load for stroke patients.

The main questions it aims to answer are:

Does wearing carbon fiber AFO can improve gait and secondary task during dual task walking for individual with stroke ? Does wearing carbon fiber AFO can reduce the prefrontal load during dual task walking for individuals with stroke?

Researchers will compare gait, concurrent task performance, and FNIRs activation over prefrontal area under different test conditions (with/without AFO, single walk, cognitive dual walk, motor dual walk)

Participants will:

execute all different conditions repeatedly in a randomized order. require to visit the lab once, about 2 hours period to complete the whole experimental protocol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

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

  • Taiwan
      • Tainan, Taiwan, 704
        • Department Physical therapy National Cheng Kung 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:

  • age over 18 years old
  • diagnosed with stroke hemoplegia
  • Mini Mental State Examination (MMSE) equal or over 24
  • able to walk independently for 15 meters without any assistive device
  • able to follow instruction

Exclusion Criteria:

  • aphasia that could not comprehend or verbally response
  • orthopedic disease of lower extremity caused discomft during walking
  • neurological disease besides stroke

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stroke
Participants with subacute or chronic stroke who could walk independently without an assistive device, demonstrated normal cognitive function (Mini-Mental State Examination (MMSE) > or equal 24), and were able to comprehend instructions and respond verbally were included.
Device: Wear an off the shelf carbon fiber ankle foot orthosis(AFO).
Participants wore an appropriately sized off-the-shelf carbon fiber ankle-foot orthosis (AFO) during the AFO-on condition, compared with not wearing an AFO during the AFO-off condition.
Procedure: Perfrom single and dual task walking.
Single-task walking was defined as walking along a 13-m pathway at a self-selected comfortable speed. Dual-task walking was defined as walking along the same pathway while concurrently performing an auditory Stroop test or holding a tray with three wooden blocks stacked on top of each other.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
walking speed
Time Frame: a single experimental session (Day 1)
calculated over a 13-m walking pathway (m/s)
a single experimental session (Day 1)
Stride time
Time Frame: a single experimental session (Day 1)
calculated over a 13-m walking pathway (s)
a single experimental session (Day 1)
Step length
Time Frame: a single experimental session (Day 1)
calculated over a 13-m walking pathway. (m)
a single experimental session (Day 1)
Reaction time
Time Frame: a single experimental session (Day 1)
time required to response during concurrent cognitive test (s)
a single experimental session (Day 1)
Correct response rate
Time Frame: a single experimental session (Day 1)
Represent the correct response rate of concurrent cognitive performance
a single experimental session (Day 1)
Sway size of holding tray
Time Frame: a single experimental session (Day 1)
The amount of sway size of holding tray during motor dual walk condition
a single experimental session (Day 1)
Functional near-infrared spectroscopy (fNIRS)
Time Frame: a single experimental session (Day 1)
oxygenated hemoglobin (HbO) concentration alternation over prefrontal area
a single experimental session (Day 1)

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

Investigators

  • Principal Investigator: YiYing Tsai, PhD, Department of Physical Therapy, National Cheng Kung 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 14, 2024

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 30, 2026

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-ER-113-100

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.

Clinical Trials on Ankle Foot Orthosis (AFO)

Clinical Trials on Wear an off the shelf carbon fiber ankle foot orthosis(AFO).

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe