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Zachycení pohybu v reálném čase a vizuální zpětná vazba pro amputaci tréninku

7. listopadu 2026 aktualizováno: Hui-Ting Shih, National Yang Ming Chiao Tung University

Účinek 2D pohybu v reálném čase a vizuální tréninkové systémy chůze na chůzi u lidí s jednostrannou transfemorální amputací

People with transfemoral amputation face challenges such as gait asymmetry, instability, and increased energy consumption due to loss of the knee joint. Because of the loss of proprioceptive feedback from their missing limbs, visual feedback is essential for gait correction. Additionally, current visual feedback systems lack portability, cost-effectiveness, and they fail to provide precise, intuitive feedback on spatiotemporal parameters, joint angles, and both frontal and sagittal plane information, limiting their effectiveness in correcting gait abnormalities.This study aims to investigate whether gait training using a real-time 2D motion capture and visual feedback gait training system (2DMV) can improve the gait biomechanics and psychosocial functions of people with unilateral transfemoral amputation (uTFA). The 2DMV system analyzes spatiotemporal parameters and joint kinematics during gait and displays the uTFA's image on a screen, providing visual feedback specifically targeting gait abnormalities. This allows individuals with uTFA to intuitively understand the feedback and make real-time gait adjustments. The biomechanical parameters include joint kinematics, gait symmetry, and walking performance.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

40

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

      • Taipei, Tchaj-wan, 112
        • Nábor
        • National Yang Ming Chiao Tung University
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 65 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Age between 18 and 65 years
  • Individuals with unilateral transfemoral amputation or knee disarticulation
  • Wear a prosthesis for at least 3 hours per day
  • Have been using a prosthesis for more than 6 months
  • Medicare Functional Classification Level (K-level) of 2 or above
  • Able to walk independently for 5 meters without assistive devices
  • No pain caused by poor prosthetic fit
  • Montreal Cognitive Assessment Taiwan Version (MoCA-T) score ≥ 26

Exclusion Criteria:

  • Uncontrolled systemic diseases (e.g., diabetes mellitus, hypertension)
  • Cardiopulmonary or cardiovascular diseases (e.g., heart failure, severe asthma)
  • History of neurological conditions that affect movement (e.g., stroke, spinal cord injury, cerebellar injury)
  • Vestibular disorders
  • Severe osteoporosis
  • Other musculoskeletal injuries or open wounds
  • Epilepsy
  • Uncorrected visual impairments
  • Congenital limb deficiency

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Real-time 2D motion capture and visual feedback system gait training group (VF)

The VF group, the 2D motion capture and visual feedback training group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of visual feedback gait training using the 2DMV system.

The difference between the VF group and the PT group lies in the use of real-time visual feedback during gait training; the VF group receives real-time visual feedback, while the PT group undergoes gait training without visual feedback.

Aktivní komparátor: Conventional physical therapy group (PT)

The PT group, the conventional physical therapy group, received an intervention consisting of 10 minutes of strength training followed by 30 minutes of gait training without the use of the 2DMV system for visual feedback. During gait training, the therapist provided standard gait correction feedback typically used in conventional physical therapy.

Ten minutes of strength training followed by thirty minutes of gait training, during which the 2DMV system is not used to provide visual feedback. During the gait training, the therapist provides gait correction feedback typically used in conventional physical therapy.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Step width ratio
Časové okno: The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Step width ratio is calculated by dividing step width by pelvis width (step width/pelvis width), and the normal range is between 0.4 to 1.1.

The step width ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Step length ratio
Časové okno: The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Step length ratio is calculated by dividing the step length of the amputated limb by the step length of the non-amputated limb (a value closer to 1 indicate more symmetry, the step length of amputated limb is calculated as the distance between the heel of the non-amputated limb when initial contact and the heel of the amputated limb when initial contact; the step length of non-amputated limb is calculated as the distance between the heel of the amputated limb when initial contact and the heel of the non-amputated limb when initial contact)

The step length ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Stride time ratio
Časové okno: The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Stride time ratio is calculated by dividing the stride time of the amputated limb by the stride time of the non-amputated limb (a value closer to 1 indicates more symmetry, the stride time of the amputated limb is calculated as the time from initial contact of the amputated limb to next initial contact of the same limb; the stride time of the non-amputated limb is calculated as the time from initial contact of the non-amputated limb to next initial contact of the same limb).

The stride time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Stance time ratio
Časové okno: The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Stance time ratio is calculated by dividing the stance time of the amputated limb by the stance time of the non-amputated limb (a value closer to 1 indicates more symmetry, the stance time is calculated from initial contact to toe off of the same limb).

The stance time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Swing time ratio
Časové okno: The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Swing time ratio is calculated by dividing the swing time of the amputated limb by the swing time of the non-amputated limb (a value closer to 1 indicates more symmetry, the swing time is calculated from toe off to initial contact of the same limb).

The swing time ratio will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Hip extension angle
Časové okno: The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The hip extension angle is measured in the sagittal plane during terminal stance.

The hip extension angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Hip flexion angle
Časové okno: The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The hip flexion angle is measured in the sagittal plane at the maximum angle of hip flexion during the swing phase.

The hip flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Trunk extension and flexion angle
Časové okno: The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The trunk extension and flexion angle is measured in the sagittal plane at the initial contact and terminal stance.

The trunk extension and flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Hip adduction and abduction angle
Časové okno: The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The hip adduction and abduction angle is measured in the coronal plane at the maximum angle of hip adduction or abduction angle during the swing phase.

The hip adduction and abduction angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Horizontal pelvis tilt angle
Časové okno: The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The horizontal pelvis tilt angle is measured in the coronal plane at the maximum pelvis tilt angle during single-leg stance.

The horizontal pelvis tilt angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Trunk lateral flexion angle
Časové okno: The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The trunk lateral flexion angle is measured in the coronal plane during midstance.

The trunk lateral flexion angle will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
The Component Timed-Up-and-Go test, cTUG
Časové okno: The Component Timed-Up-and-Go test will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The participant will first be instructed to sit on a chair with a backrest. When the assessor says 'go,' the participant will stand up, walk forward, circle around a cone, return to the chair, and sit down, all at a self-selected speed. The assessor will time the duration of the entire process. The timing of the Component Timed-Up-and-Go test will be divided into five components: standing up, walking forward, circling around the cone, walking back to the chair, and sitting down. Time will be measured in seconds.

The Component Timed-Up-and-Go test will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
Gait speed
Časové okno: The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

Gait speed will be measured by the assessor with a timer. The participant will be instructed to walk 5 meters at a self-selected speed. The first and last 1 meter will serve as the acceleration and deceleration phases, while the gait speed in middle 3 meters will be measured. Time will be measured in seconds.

The gait speed will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The Activities-specific Balance Confidence Scale, ABC scale
Časové okno: The Activities-specific Balance Confidence Scale will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.

The Activities-specific Balance Confidence Scale is a self-reported questionnaire used to assess balance confidence. Scores range from 0% to 100%, with higher scores indicating greater confidence. The scale consists of 16 items in total.

The Activities-specific Balance Confidence Scale will be measured at Day 1, before the 1st intervention session, and after the 12th intervention session.
The National Aeronautics and Space Administration Task Load Index, NASA-TLX
Časové okno: The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.

The National Aeronautics and Space Administration Task Load Index is a self-repoted scale, totally has 6 items, including mental demand, physical demand, temporal demand, performance, effort, and frustration. The score will recorded as 0 to 100, with the higher score indicating higher work load.

The National Aeronautics and Space Administration Task Load Index will be measured after the 12th intervention session.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

20. srpna 2025

Primární dokončení (Odhadovaný)

10. července 2027

Dokončení studie (Odhadovaný)

31. července 2027

Termíny zápisu do studia

První předloženo

13. května 2025

První předloženo, které splnilo kritéria kontroly kvality

1. července 2025

První zveřejněno (Aktuální)

3. července 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • NYCU114067AE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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