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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YiYing Tsai, PhD | Department of Physical Therapy, National Cheng Kung University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department Physical therapy National Cheng Kung University | Tainan | 704 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28615042 | Background | 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. | |
| 25856154 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 29, 2024 |
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Single group, repeated measure
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| 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. |
|
| 35753183 | Background | 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. |
| 18058946 | Background | 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. |
| 28949119 | Background | 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. |
| 23416220 | 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. |
| 35525151 | 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. |
| 30463576 | 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. |
| 32865134 | 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. |
| 32630216 | Background | 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. |
| 28924563 | Background | 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. |
| 36779973 | 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. |
| 33063635 | 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. |
| 16934470 | 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. |
| 33013625 | 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. |
| 32432905 | 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. |
| 15370732 | 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. |
| 34354172 | 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. |
| 22050974 | Background | 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. |
| 17635208 | Background | 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. |
| 25254140 | Background | 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. |
| 34128859 | 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. |
| Mar 18, 2026 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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