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Ankle Foot Orthosis (AFO)NCT07500662

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

A study testing Wear an off the shelf carbon fiber ankle foot orthosis(AFO). and Perfrom single and dual task walking. in people with Ankle Foot Orthosis (AFO) and Dual Task Walking, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ankle Foot Orthosis (AFO), Dual Task Walking
What is being tested?
Wear an off the shelf carbon fiber ankle foot orthosis(AFO). and Perfrom single and dual task walking.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteTaiwan
Study dates
14 Oct 2024to 30 Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Department Physical therapy National Cheng Kung University

    Tainan, 704

Other trials in Taiwan

About this study

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:

Read more

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.

Being tested
Wear an off the shelf carbon fiber ankle foot orthosis(AFO)., Perfrom single and dual task walking.
Keywords
stroke, dual task walking, AFO, FNIRs
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Wear an off the shelf carbon fiber ankle foot orthosis(AFO).Device

    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.

  • Perfrom single and dual task walking.Procedure or surgery

    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.

Study groups in NCT07500662
Study groupRoleWhat they receive
StrokeExperimentalParticipants 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.
Receives: Device: Wear an off the shelf carbon fiber ankle foot orthosis(AFO).; Procedure: Perfrom single and dual task walking.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. walking speed

    calculated over a 13-m walking pathway (m/s)

    Measured: a single experimental session (Day 1)

  2. Stride time

    calculated over a 13-m walking pathway (s)

    Measured: a single experimental session (Day 1)

  3. Step length

    calculated over a 13-m walking pathway. (m)

    Measured: a single experimental session (Day 1)

  4. Reaction time

    time required to response during concurrent cognitive test (s)

    Measured: a single experimental session (Day 1)

  5. Correct response rate

    Represent the correct response rate of concurrent cognitive performance

    Measured: a single experimental session (Day 1)

  6. Sway size of holding tray

    The amount of sway size of holding tray during motor dual walk condition

    Measured: a single experimental session (Day 1)

  7. Functional near-infrared spectroscopy (fNIRS)

    oxygenated hemoglobin (HbO) concentration alternation over prefrontal area

    Measured: a single experimental session (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2026
  2. Study start14 Oct 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Single group, repeated measure
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07500662
Sponsor's protocol ID
B-ER-113-100
Status last verified
Mar 2026
First submitted
13 Mar 2026
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Darekar A, Lamontagne A, Fung J. Locomotor circumvention strategies are altered by stroke: I. Obstacle clearance. J Neuroeng Rehabil. 2017 Jun 15;14(1):56. doi: 10.1186/s12984-017-0264-8.

    PubMed 28615042

  • Zou D, He T, Dailey M, Smith KE, Silva MJ, Sinacore DR, Mueller MJ, Hastings MK. Experimental and computational analysis of composite ankle-foot orthosis. J Rehabil Res Dev. 2014;51(10):1525-36. doi: 10.1682/JRRD.2014-02-0046.

    PubMed 25856154

  • Zhuang C, Meidenbauer KL, Kardan O, Stier AJ, Choe KW, Cardenas-Iniguez C, Huppert TJ, Berman MG. Scale invariance in fNIRS as a measurement of cognitive load. Cortex. 2022 Sep;154:62-76. doi: 10.1016/j.cortex.2022.05.009. Epub 2022 May 31.

    PubMed 35753183

  • Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720.

    PubMed 18058946

  • Yang L, Lam FM, Huang M, He C, Pang MY. Dual-task mobility among individuals with chronic stroke: changes in cognitive-motor interference patterns and relationship to difficulty level of mobility and cognitive tasks. Eur J Phys Rehabil Med. 2018 Aug;54(4):526-535. doi: 10.23736/S1973-9087.17.04773-6. Epub 2017 Sep 25.

    PubMed 28949119

  • Tyson SF, Kent RM. Effects of an ankle-foot orthosis on balance and walking after stroke: a systematic review and pooled meta-analysis. Arch Phys Med Rehabil. 2013 Jul;94(7):1377-85. doi: 10.1016/j.apmr.2012.12.025. Epub 2013 Feb 12.

    PubMed 23416220

  • St George RJ, Jayakody O, Healey R, Breslin M, Hinder MR, Callisaya ML. Cognitive inhibition tasks interfere with dual-task walking and increase prefrontal cortical activity more than working memory tasks in young and older adults. Gait Posture. 2022 Jun;95:186-191. doi: 10.1016/j.gaitpost.2022.04.021. Epub 2022 Apr 26.

    PubMed 35525151

  • Russell Esposito E, Schmidtbauer KA, Wilken JM. Experimental comparisons of passive and powered ankle-foot orthoses in individuals with limb reconstruction. J Neuroeng Rehabil. 2018 Nov 21;15(1):111. doi: 10.1186/s12984-018-0455-y.

    PubMed 30463576

  • Nobrega-Sousa P, Gobbi LTB, Orcioli-Silva D, Conceicao NRD, Beretta VS, Vitorio R. Prefrontal Cortex Activity During Walking: Effects of Aging and Associations With Gait and Executive Function. Neurorehabil Neural Repair. 2020 Oct;34(10):915-924. doi: 10.1177/1545968320953824. Epub 2020 Aug 31.

    PubMed 32865134

  • Holtzer R, Izzetoglu M. Mild Cognitive Impairments Attenuate Prefrontal Cortex Activations during Walking in Older Adults. Brain Sci. 2020 Jul 1;10(7):415. doi: 10.3390/brainsci10070415.

    PubMed 32630216

  • Herold F, Wiegel P, Scholkmann F, Thiers A, Hamacher D, Schega L. Functional near-infrared spectroscopy in movement science: a systematic review on cortical activity in postural and walking tasks. Neurophotonics. 2017 Oct;4(4):041403. doi: 10.1117/1.NPh.4.4.041403. Epub 2017 Aug 1.

    PubMed 28924563

  • Grunst MM, Wiederien RC, Wilken JM. Carbon fiber ankle-foot orthoses in impaired populations: A systematic review. Prosthet Orthot Int. 2023 Oct 1;47(5):457-465. doi: 10.1097/PXR.0000000000000217. Epub 2023 Feb 10.

    PubMed 36779973

  • Drake R, Parker K, Clifton KL, Allen S, Adderson J, Mountain A, Eskes GA. Ankle-foot orthoses improve walking but do not reduce dual-task costs after stroke. Top Stroke Rehabil. 2021 Sep;28(6):463-473. doi: 10.1080/10749357.2020.1834271. Epub 2020 Oct 16.

    PubMed 33063635

  • Desloovere K, Molenaers G, Van Gestel L, Huenaerts C, Van Campenhout A, Callewaert B, Van de Walle P, Seyler J. How can push-off be preserved during use of an ankle foot orthosis in children with hemiplegia? A prospective controlled study. Gait Posture. 2006 Oct;24(2):142-51. doi: 10.1016/j.gaitpost.2006.08.003. Epub 2006 Aug 24.

    PubMed 16934470

  • Deblock-Bellamy A, Lamontagne A, Blanchette AK. Cognitive-Locomotor Dual-Task Interference in Stroke Survivors and the Influence of the Tasks: A Systematic Review. Front Neurol. 2020 Aug 18;11:882. doi: 10.3389/fneur.2020.00882. eCollection 2020.

    PubMed 33013625

Questions about this trial

What is this clinical trial studying?

A study testing Wear an off the shelf carbon fiber ankle foot orthosis(AFO). and Perfrom single and dual task walking. in people with Ankle Foot Orthosis (AFO) and Dual Task Walking, run by National Cheng-Kung University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

walking speed (time frame: a single experimental session (Day 1)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07500662, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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