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Motor Imagery for Prosthetic Gait Training in Transtibial Amputees

11. června 2026 aktualizováno: Ariel University

Motor Imagery Prior to or Alongside Initial Prosthetic Gait Training in Acute Transtibial Amputees: A Feasibility Pilot Study

This study included the development of motor imagery (i.e., the cognitive process of mentally reheasing a motor task) protocol for improving prosthetic gait among acute transtibial amputees. Further, the researchers investigated whether praciticng motor imagery before or alongside initial temporary prosthetic training (aka VESSA) would affect measures of functional status, pain, prosthethis embodiement and motor imagery ability.

Přehled studie

Detailní popis

Background: People undergoing transtibial amputation (TTA) face impairments in gait, balance, confidence, pain, and prosthesis embodiment. Motor imagery (MI) is a cognitive approach for addressing motor and cognitive performance. The current study aimed to (1) explore the feasibility of MI for individuals with acute TTA and (2) investigate the preliminary effects of MI on participants' functional status, gait, pain, prosthesis embodiment and imagery ability.

Methods: Ten participants (age range: 46-68 years, eight males) with acute unilateral TTA were randomly allocated into two groups based on delivery timing of MI in relation to temporary prosthesis (Vessa) training: prior to (pre-Vessa) or alongside (w-Vessa), both concurrently with conventional physical therapy. Participants underwent eight individualized MI sessions over two weeks. Data were collected at four timepoints: before and after MI, first independent prosthesis gait, and discharge from the hospital. Outcome measures included intervention feasibility, functional status, pain, prosthesis embodiment and imagery ability.

Typ studie

Intervenční

Zápis (Aktuální)

10

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 místa

      • Raanana, Izrael
        • Loewenstein Rehabilitation Hospital

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

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Unilateral transtibial amputation
  • No experience with VESSA training

Exclusion Criteria:

  • Vestibular and/or cerebellar disorders
  • Cognitive impairments (e.g., mental retardation)
  • Hearing and/or visual impairment
  • Bilateral amputation
  • Acute medical exacerbation in the past two weeks

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: Jiný
  • Přidělení: Randomizované
  • Intervenční model: Sekvenční přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Pre VESSA
Participants attended the motor imagery training prior to beginning actual temporary prosthetic (VESSA) training

The motor imagery intervention aimed to: (1) introduce rationale, mechanisms of action, and advantages of MI; (2) facilitate kinesthetic and functional familiarization with the prosthesis; and (3) enhance prosthetic gait, weight-bearing, balance and turning.

The protocol followed MI paradigms and methodologies (e.g., combining visual and kinesthetic modalities), including the PETTLEP model that was previously used in amputees. The MI contents addressed movement range of motion, quality, timing, and lower extremity and whole-body intersegmental coordination with motor tasks serving as outcome measures not being explicitly practiced.

The following components were included:

  1. Introduction to MI- definition, mechanisms of effect, advantages, modalities, and perspectives.
  2. Acquaintance with and embodiment of the stump, MI of the prosthesis and MI of the stump-prosthesis interaction (e.g., contact area, pressure).
  3. Weight bearing and shifting during sit-to-stand, standing and gait.
Ostatní jména:
  • Mentální představivost
  • Motor Imagery Practice
Experimentální: With VESSA
Participants attended the motor imagery training alongside actual temporary prosthetic (VESSA) training

The motor imagery intervention aimed to: (1) introduce rationale, mechanisms of action, and advantages of MI; (2) facilitate kinesthetic and functional familiarization with the prosthesis; and (3) enhance prosthetic gait, weight-bearing, balance and turning.

The protocol followed MI paradigms and methodologies (e.g., combining visual and kinesthetic modalities), including the PETTLEP model that was previously used in amputees. The MI contents addressed movement range of motion, quality, timing, and lower extremity and whole-body intersegmental coordination with motor tasks serving as outcome measures not being explicitly practiced.

The following components were included:

  1. Introduction to MI- definition, mechanisms of effect, advantages, modalities, and perspectives.
  2. Acquaintance with and embodiment of the stump, MI of the prosthesis and MI of the stump-prosthesis interaction (e.g., contact area, pressure).
  3. Weight bearing and shifting during sit-to-stand, standing and gait.
Ostatní jména:
  • Mentální představivost
  • Motor Imagery Practice

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Feasibility: Participants' Recruitement
Časové okno: Within 72 hours post-intervention
The actual number of participants successfully recruited for each group
Within 72 hours post-intervention
Feasiblity: Safety
Časové okno: Within 72 hours post-intervention
The lack of adverse events or negative effects throughout the intervention.
Within 72 hours post-intervention
Feasibility: Compliance
Časové okno: Within 72 hours post-intervention
The percentage of MI sessions successfully complated by participants
Within 72 hours post-intervention
Feasibility: Participants' Feedback
Časové okno: Within 72 hours post-intervention
Opinions and insights expressed by the participants about the intervention.
Within 72 hours post-intervention
Amputee Mobility Predictor
Časové okno: Within 72 hours prior to initial VESSA training
A functional assessment of mobility level for determining the appropriate prosthetic prescription. The test consists of 21 daily living functional motor tasks (e.g., turning, sitting down, and walking over an obstacle). Scores are "0" ('inability to perform the task'), "1" ('minimal level of achievement or that some assistance was required in completing the task'), or "2" ('complete independence or mastery of the task'). A higher score indicates a greater level of prosthesis function.
Within 72 hours prior to initial VESSA training
Daily Functioning Ability Test
Časové okno: Within 72 hours pre-intervention, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)
An 18-item test for assessing patients' daily functioning inside and outside the hospital ward. Each item is rated on a 7-point scale, with higher scores representing less assistance needed by the patient. Scoring categories are: fully independent (109-126), independent with assistance devices (91-108), requiring supervision (73-90), requiring assistance (37-72), and fully dependent (nursing care; 18-36). Higher scores mean a better outcome.
Within 72 hours pre-intervention, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)
Timed Up and Go
Časové okno: Once first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)
A functional test for quantifying functional mobility. The participants are asked to rise from a chair, walk 3 meters, turn around an obstacle, and return to take a seat as quickly and safely as possible. The average time (in seconds) of two trials was recorded using a stopwatch. Lower scores mean a better outcome.
Once first independent gait is possible (up to 72 hours) and at discharge from the rehabilitation center (up to 72 hours)
Ten-meter Walk Test
Časové okno: Once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours)
A functional test for assessing early gait after amputation. The time (in seconds) for completing a ten-meter forward walk was recorded.
Once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Prosthesis Embodiment Scale of Lower Limb Amputees
Časové okno: Within 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).
A 10-item questionnaire for assessing perceptual correlates of successful body-prosthesis interaction (i.e., acceptance). Scores for each item are on a 7-point Likert scale ranging from "-3" ('strongly disagree') to "+3" ('strongly agree'). Higher scores mean better outcome (i.e., higher prosthesis embodiment).
Within 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).
McGill Pain Questionnaire-Short Form
Časové okno: Within 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).
A 17-item self-administered questionnaire for assessing pain, including post amputation pain. The questionnaire includes three sections: pain visual analog scale (VAS; 0-10 scale), pain intensity index (PPI; 0-5 scale), and total McGill score (0-45 scale). Higher scores mean worse outcome (i.e., higher levels of pain).
Within 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).
Kinesthetic Visual Imagery Questionnaire
Časové okno: Within 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).
A 5-item questionnaire for assessing MI clarity (visual subscale) and intensity (kinesthetic subscale) of motor tasks, including the amputated ('affected') and intact ('unaffected') . Scores range between "1" ('no image at all') and "5" ('image as clear as seeing'). Higher scores mean a better outcome.
Within 72 hours pre-internvetion, within 72 hours post-intervention, once first independent gait is possible (up to 72 hours), and at discharge from the rehabilitation center (up to 72 hours).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Ředitel studie: Amir Haim, MD, Loewenstein Rehabilitation Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

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)

10. ledna 2023

Primární dokončení (Aktuální)

20. října 2023

Dokončení studie (Aktuální)

20. října 2023

Termíny zápisu do studia

První předloženo

1. června 2026

První předloženo, které splnilo kritéria kontroly kvality

11. června 2026

První zveřejněno (Aktuální)

17. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

17. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 0017-22-LOE

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

Collected data (without identifiers) will be shared upon request submitted by email to the researchers.

Časový rámec sdílení IPD

Data will be available once the manuscript is published and for approximately 2 years.

Typ podpůrných informací pro sdílení IPD

  • PROTOKOL STUDY
  • ICF

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Klinické studie na Motor Imagery

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