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

NCT07500662 | Completed

• 1 other identifier: B-ER-113-100
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Ankle Foot Orthosis (AFO); Dual Task Walking

Keywords

stroke; dual task walking; AFO; FNIRs

Outcome Measures

Primary Outcomes (7)

• walking speed

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

  a single experimental session (Day 1)

• Stride time

  calculated over a 13-m walking pathway (s)

  a single experimental session (Day 1)

• Step length

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

  a single experimental session (Day 1)

• Reaction time

  time required to response during concurrent cognitive test (s)

  a single experimental session (Day 1)

• Correct response rate

  Represent the correct response rate of concurrent cognitive performance

  a single experimental session (Day 1)

• Sway size of holding tray

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

  a single experimental session (Day 1)

• Functional near-infrared spectroscopy (fNIRS)

  oxygenated hemoglobin (HbO) concentration alternation over prefrontal area

  a single experimental session (Day 1)

Study Arms (1)

Stroke

EXPERIMENTAL

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).; Procedure: Perfrom single and dual task walking.

Interventions

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.

Stroke

Perfrom single and dual task walking. PROCEDURE

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.

Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Department Physical therapy National Cheng Kung University

Tainan, 704, Taiwan

Location

Related Publications (22)

• Darekar A,Lamontagne A,Fung J

  BACKGROUND

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  PMID: 25856154 BACKGROUND

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  PMID: 28949119 BACKGROUND

• 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.

  PMID: 23416220 BACKGROUND

• 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.

  PMID: 35525151 BACKGROUND

• 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.

  PMID: 30463576 BACKGROUND

• 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.

  PMID: 32865134 BACKGROUND

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  PMID: 28924563 BACKGROUND

• 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.

  PMID: 36779973 BACKGROUND

• 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.

  PMID: 33063635 BACKGROUND

• 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.

  PMID: 16934470 BACKGROUND

• 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.

  PMID: 33013625 BACKGROUND

• Daryabor A, Yamamoto S, Orendurff M, Kobayashi T. Effect of types of ankle-foot orthoses on energy expenditure metrics during walking in individuals with stroke: a systematic review. Disabil Rehabil. 2022 Jan;44(2):166-176. doi: 10.1080/09638288.2020.1762767. Epub 2020 May 20.

  PMID: 32432905 BACKGROUND

• Danielsson A, Sunnerhagen KS. Energy expenditure in stroke subjects walking with a carbon composite ankle foot orthosis. J Rehabil Med. 2004 Jul;36(4):165-8. doi: 10.1080/16501970410025126.

  PMID: 15370732 BACKGROUND

• Choo YJ, Chang MC. Effectiveness of an ankle-foot orthosis on walking in patients with stroke: a systematic review and meta-analysis. Sci Rep. 2021 Aug 5;11(1):15879. doi: 10.1038/s41598-021-95449-x.

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• Bregman DJ, Harlaar J, Meskers CG, de Groot V. Spring-like Ankle Foot Orthoses reduce the energy cost of walking by taking over ankle work. Gait Posture. 2012 Jan;35(1):148-53. doi: 10.1016/j.gaitpost.2011.08.026. Epub 2011 Nov 1.

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• Bartonek A, Eriksson M, Gutierrez-Farewik EM. Effects of carbon fibre spring orthoses on gait in ambulatory children with motor disorders and plantarflexor weakness. Dev Med Child Neurol. 2007 Aug;49(8):615-20. doi: 10.1111/j.1469-8749.2007.00615.x.

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• Balasubramanian CK, Clark DJ, Fox EJ. Walking adaptability after a stroke and its assessment in clinical settings. Stroke Res Treat. 2014;2014:591013. doi: 10.1155/2014/591013. Epub 2014 Aug 28.

  PMID: 25254140 BACKGROUND

• Baek CY, Yoon HS, Kim HD, Kang KY. The effect of the degree of dual-task interference on gait, dual-task cost, cognitive ability, balance, and fall efficacy in people with stroke: A cross-sectional study. Medicine (Baltimore). 2021 Jun 18;100(24):e26275. doi: 10.1097/MD.0000000000026275.

  PMID: 34128859 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• YiYing Tsai, PhD

  Department of Physical Therapy, National Cheng Kung University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisitant Professor

Model Details: Single group, repeated measure

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 30, 2026
• Study Start: October 14, 2024
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)