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Completed

NCT Number: NCT07500662

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

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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Key information

Conditions

Ankle Foot Orthosis (AFO) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dual Task Walking Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department Physical therapy National Cheng Kung University

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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.

Primary outcomes

  1. walking speed

    Time frame: a single experimental session (Day 1)

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

  2. Stride time

    Time frame: a single experimental session (Day 1)

    calculated over a 13-m walking pathway (s)

  3. Step length

    Time frame: a single experimental session (Day 1)

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

  4. Reaction time

    Time frame: a single experimental session (Day 1)

    time required to response during concurrent cognitive test (s)

  5. Correct response rate

    Time frame: a single experimental session (Day 1)

    Represent the correct response rate of concurrent cognitive performance

  6. 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

  7. Functional near-infrared spectroscopy (fNIRS)

    Time frame: a single experimental session (Day 1)

    oxygenated hemoglobin (HbO) concentration alternation over prefrontal area

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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