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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07500662
Enrollment
26
Registered
2026-03-30
Start date
2024-10-14
Completion date
2025-09-30
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Foot Orthosis (AFO), Dual Task Walking

Keywords

stroke, dual task walking, AFO, FNIRs

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.

Interventions

DEVICEWear 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.

PROCEDUREPerfrom 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.

Sponsors

National Cheng-Kung University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Single group, repeated measure

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
walking speeda single experimental session (Day 1)calculated over a 13-m walking pathway (m/s)
Stride timea single experimental session (Day 1)calculated over a 13-m walking pathway (s)
Step lengtha single experimental session (Day 1)calculated over a 13-m walking pathway. (m)
Reaction timea single experimental session (Day 1)time required to response during concurrent cognitive test (s)
Correct response ratea single experimental session (Day 1)Represent the correct response rate of concurrent cognitive performance
Sway size of holding traya single experimental session (Day 1)The amount of sway size of holding tray during motor dual walk condition
Functional near-infrared spectroscopy (fNIRS)a single experimental session (Day 1)oxygenated hemoglobin (HbO) concentration alternation over prefrontal area

Countries

Taiwan

Contacts

PRINCIPAL_INVESTIGATORYiYing Tsai, PhD

Department of Physical Therapy, National Cheng Kung University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026