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Motor Imagery for Prosthetic Gait Training in Transtibial Amputees

11 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

10

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Raanana, Israele
        • Loewenstein Rehabilitation Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Immagini mentali
  • Motor Imagery Practice
Sperimentale: 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.
Altri nomi:
  • Immagini mentali
  • Motor Imagery Practice

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility: Participants' Recruitement
Lasso di tempo: Within 72 hours post-intervention
The actual number of participants successfully recruited for each group
Within 72 hours post-intervention
Feasiblity: Safety
Lasso di tempo: Within 72 hours post-intervention
The lack of adverse events or negative effects throughout the intervention.
Within 72 hours post-intervention
Feasibility: Compliance
Lasso di tempo: Within 72 hours post-intervention
The percentage of MI sessions successfully complated by participants
Within 72 hours post-intervention
Feasibility: Participants' Feedback
Lasso di tempo: Within 72 hours post-intervention
Opinions and insights expressed by the participants about the intervention.
Within 72 hours post-intervention
Amputee Mobility Predictor
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Prosthesis Embodiment Scale of Lower Limb Amputees
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Direttore dello studio: Amir Haim, MD, Loewenstein Rehabilitation Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

10 gennaio 2023

Completamento primario (Effettivo)

20 ottobre 2023

Completamento dello studio (Effettivo)

20 ottobre 2023

Date di iscrizione allo studio

Primo inviato

1 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 giugno 2026

Primo Inserito (Effettivo)

17 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

17 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 0017-22-LOE

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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

Periodo di condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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