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The Role of Visual Attention and Environmental Complexity in Real-world Mobility for People With Lower Limb Amputation

2026. szeptember 17. frissítette: Virginia Commonwealth University

Despite high medical expenses (>$500K/patient), mobility improvements achieved during rehabilitation for people with lower limb amputation (LLA) fail to translate into improved real-world outcomes. Even with advances in prosthesis technology enabling faster gait speed, greater walking endurance, and improved mobility confidence, people with LLA report persistent dissatisfaction with real-world mobility, limited ability to walk in the community, and difficulty achieving recommended physical activity levels.

Real-world walking requires thinking and moving simultaneously (e.g., cognitive-motor dual-tasking), visually attending to the environment, and navigating varying terrain. In contrast, clinical mobility assessments are usually performed without additional visual or cognitive demands, in controlled environments, and on level surfaces. Current clinical tools used to assess ambulation progression during rehabilitation do not adequately assess these changes in people who have experienced LLA.

A tanulmány áttekintése

Részletes leírás

A step toward rectifying a critical gap in care for those with LLA by quantifying the effect of vision-based and non-vision-based cognitive-motor dual-tasking and high and low complexity terrain on gait speed and gaze behavior. Cognitive-motor dual-task assessment paradigms are well-established in other populations and often used to better approximate real-world walking demands. However, the type of cognitive task used is an important factor. The most common methods for dual-task assessment in people with LLA are limited to cognitive tasks lacking overt visual attention (e.g., serial subtraction - performing repeated subtractions from a given starting number).Although walking while performing non-vision-based cognitive tasks results in slower gait speed than single-task walking, this type of task has limited ecological validity and the observed dual-task performances have not been associated with real-world walking outcomes.

Performing vision-based cognitive-motor dual-tasks is particularly important for people with LLA. Due to lost somatosensory input from the amputated limb, the central nervous system increases dependence on visual input for sensorimotor integration. As a result, people with LLA report needing to "concentrate on every step", and affix their gaze on each subsequent step compared to 3 steps ahead like adults without LLA.

Current clinical assessments fail to detect impairments during mobility tasks requiring visual attention in complex environments. The lack of understanding of the interaction between visual attention and complex environment precludes a comprehensive mobility assessment, allows undetected impairments to persist, and limits translation of rehabilitation gains into improved real-world mobility outcomes.

Tanulmány típusa

Megfigyelő

Beiratkozás (Becsült)

30

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

    • Virginia
      • Richmond, Virginia, Egyesült Államok, 23239
        • Toborzás
        • Virginia Commonwealth University
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Paul Kline

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év és régebbi (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Összes

Mintavételi módszer

Valószínűségi minta

Tanulmányi populáció

We will compare gait speed (Aim1) and gaze behavior with eye-tracking glasses (Aim 2) during vision-based (visual puzzles) and non-vision-based (serial subtraction) cognitive-motor dual-tasking while walking on low and high complexity terrain in people with LLA (n=20) and matched controls (n=10).

Leírás

Inclusion Criteria:

  • unilateral transtibial LLA of either dysvascular (diabetes, peripheral vascular disease, and/or infection) or traumatic etiology
  • 18 years old minimum
  • able to ambulate 2 minutes without rest
  • 9 months since LLA
  • fitted with terminal prosthesis
  • 20/60 vision or better (with or without glasses/contacts)

Exclusion Criteria:

  • congenital or cancer-related LLA
  • ankle-level or above LLA on the contralateral limb
  • residual limb wound or contralateral foot ulcer
  • unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)
  • acute systemic infection
  • prisoner
  • inability to follow a 3-step command
  • concussion/brain injury in the past 12 months
  • active cancer treatment
  • preexisting neurological condition (i.e., multiple sclerosis, Parkinson's disease)
  • participating in prosthetic rehabilitation
  • color-blindness
  • history of seizure(s)
  • inability to read and communicate in English.

Participants in the control group must meet the non-amputation-related criteria noted above, be within ±2 years and the same biological sex as their paired participants with LLA.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Megfigyelési modellek: COHORT
  • Időperspektívák: PROSPECTIVE

Kohorszok és beavatkozások

Csoport / Kohorsz
Beavatkozás / kezelés
Subjects with Lower Limb Amputation (LLA)

20 participants with below knee amputation.

Assessment of accelerometry: Daily duration (minutes) of sitting, standing, stepping, Daily step count, Daily walking bouts stepping cadence, Timed Up and Go and Two-minute Walk Test

Comprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations

The following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.

Matched Control

10 sex- and age-matched control participants.

Assessment of accelerometry: Daily duration (minutes) of sitting, standing, stepping, Daily step count, Daily walking bouts stepping cadence, Timed Up and Go and Two-minute Walk Test

Comprehensive assessment of eye movements during walking including Target Fixation Time (seconds; %) and Number of fixations

The following assessments will be completed: World health organization disability assessment schedule 2.0 (WHODAS), and Activities Specific Balance Confidence Scale.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Gait Analysis-Walking Speed
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Measure walking speed meters/second. Captured during dual-task and single-task walking, it is used to measure motor performance. Normal Speed: Healthy adults usually walk at 1.2 to 1.4 meters per second.Fall Risk: A speed below 1.0 meter per second shows a higher risk for falls.Frailty Warning: A speed below 0.6 to 0.8 meters per second suggests a high risk of functional decline or disability.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Gait Analysis-Stride Length
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Measure the stride length in meters. stride length is the total distance covered during one full cycle of walking or running with the same foot. It measures the space from where one foot touches the ground to when that exact same foot touches the ground again.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Gait Analysis-Stride length asymmetry
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Assess Stride length asymmetry is an imbalance where the distance covered by the right and left steps differs. Symmetry Index (SI): Compares spatial step metrics or temporal single-limb support times between limbs.Percentage difference: Calculated by contrasting mean left and right step values; values exceeding 10% typically indicate notable dysfunction.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Cognitive Task Performance Cognitive Task Performance
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Accuracy (percentage correct) of each cognitive task. This reflects cognitive performance and is measured in both dual-task and single-task conditions.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Cognitive Task Performance
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Measure Response time (milliseconds)

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Functional Mobility (Two-minute Walk Test)
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Two-minute Walk Test measures the total distance a person can walk on a flat, hard surface within two minutes. It evaluates functional mobility, submaximal endurance, and self-paced walking capacity in adults. Recorded to the nearest meter or foot using a measuring wheel, and lap count.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Functional Mobility (Timed Up and Go)
Időkeret: Visit 1

Timed Up and Go (TUG) test measures functional mobility, dynamic balance, and fall risk by timing how fast a person stands from a chair, walks 3 meters (10 feet), turns around, walks back, and sits down. Under 10-12 seconds: Normal, independent mobility with low fall risk.12-20 seconds: Moderate risk of falling or subtle mobility issues; requires further evaluation.Over 14-20 seconds: High risk for falls; often indicates difficulty moving outside alone or a need for assistive devices.

Visit 1
Eye Tracking (Target Fixation Time)
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Target Fixation Time (seconds; %), The length of time the eye remains relatively still on a target to process detail, reflecting visual attention.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Eye Tracking (Number of fixations)
Időkeret: Visit 1 and visit 2 (which will take place 10-14 days after visit 1)

Number of fixations is a core metric measuring how many times a person's eyes pause and focus on a specific area or object. High Fixation Count: indicates frequent attention on an area or element. Low Fixation Count: Means an element was quickly passed over, easily understood, or ignored.

Visit 1 and visit 2 (which will take place 10-14 days after visit 1)
Patient Reported Outcomes (Houghton Scale)
Időkeret: Visit 1

The Houghton Scale assesses a person's confidence and ability in using their prosthesis safely and effectively during everyday mobility tasks. The Houghton Scale is a self-administered, 4-item questionnaire used to assess the functional use of a prosthesis by individuals with lower-limb amputations.It measures how often a patient wears their prosthesis, the types of activities they perform with it, and their perceived stability in various outdoor environments. Total scores range from 0 to 12, with higher scores indicating greater prosthesis use and independence

Visit 1
Patient Reported Outcomes (PEQ - Mobility subscale)
Időkeret: Visit 1

PEQ - Mobility subscale is the The Prosthesis Evaluation Questionnaire - Mobility subscale, captures a person's self reported ability to move and perform daily activities while using their prosthesis. It uses a 5-point ordinal scale (0-4). 0: Not able or hardly able to 4: No problem or almost fully able. The total scale ranges from 0 to 48. A higher score indicates greater mobility.

Visit 1
Patient Reported Outcomes (WHODAS)
Időkeret: Visit 1

WHODAS The World health organization disability assessment schedule 2.0 (WHODAS) evaluates how health conditions impact a person's functioning and participation across major life domains over the past 30 days. Items are rated on a 5-point Likert scale: None (0), Mild (1), Moderate (2), Severe (3), and Extreme or Cannot Do (4). While no universal "cut-off" exists, scores placing a patient in the top 10% of the population distribution-roughly >10 for the 12-item simple score or >41 for the 36-item version-likely indicate significant impairment.

Visit 1
Patient Reported Outcomes (Activities Specific Balance Confidence Scale)
Időkeret: Visit 1

Activities Specific Balance Confidence Scale is a self-report instrument used to measure an individual's confidence in maintaining balance while performing 16 various daily activities. Unlike performance-based tests, it captures the patient's perceived ability to avoid falling or becoming unsteady.Patients rate their confidence for each item on a scale from 0% (no confidence) to 100% (complete confidence). The higher the score,the higher the function and physical activity (range > 80% high function, 50% - 80% moderate function and < 50% low function.

Visit 1
Accelerometry (Daily duration of sitting, standing, stepping)
Időkeret: Between Visit 1 and 2 (which is 10-14 days after visit 1)

Daily duration (minutes) of sitting, standing, and stepping reported as an aggregate mean.

Between Visit 1 and 2 (which is 10-14 days after visit 1)
Accelerometry (Daily step count)
Időkeret: Between Visit 1 and 2 (which is 10-14 days after visit 1)

Daily step count will be measured and reported as an aggregate mean.

Between Visit 1 and 2 (which is 10-14 days after visit 1)
Accelerometry (Daily walking bouts stepping cadence)
Időkeret: Between Visit 1 and 2 (which is 10-14 days after visit 1)

Daily walking bouts stepping cadence will be reported as an aggregate mean

Between Visit 1 and 2 (which is 10-14 days after visit 1)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Nyomozók

  • Kutatásvezető: Paul Kline, Virginia Commonwealth University

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2025. október 25.

Elsődleges befejezés (Becsült)

2027. május 31.

A tanulmány befejezése (Becsült)

2027. május 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. szeptember 14.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 17.

Első közzététel (Tényleges)

2026. szeptember 21.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. szeptember 21.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. szeptember 17.

Utolsó ellenőrzés

2026. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Egyéb vizsgálati azonosító számok

  • HM20030568

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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