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Motor Imagery for Prosthetic Gait Training in Transtibial Amputees

2026年6月11日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (実際)

10

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Raanana、イスラエル
        • Loewenstein Rehabilitation Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:他の
  • 割り当て:ランダム化
  • 介入モデル:順次割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の名前:
  • 心的イメージ
  • Motor Imagery Practice
実験的: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.
他の名前:
  • 心的イメージ
  • Motor Imagery Practice

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Feasibility: Participants' Recruitement
時間枠:Within 72 hours post-intervention
The actual number of participants successfully recruited for each group
Within 72 hours post-intervention
Feasiblity: Safety
時間枠:Within 72 hours post-intervention
The lack of adverse events or negative effects throughout the intervention.
Within 72 hours post-intervention
Feasibility: Compliance
時間枠:Within 72 hours post-intervention
The percentage of MI sessions successfully complated by participants
Within 72 hours post-intervention
Feasibility: Participants' Feedback
時間枠:Within 72 hours post-intervention
Opinions and insights expressed by the participants about the intervention.
Within 72 hours post-intervention
Amputee Mobility Predictor
時間枠: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
時間枠: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
時間枠: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
時間枠: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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Prosthesis Embodiment Scale of Lower Limb Amputees
時間枠: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
時間枠: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
時間枠: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).

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • スタディディレクター:Amir Haim, MD、Loewenstein Rehabilitation Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年1月10日

一次修了 (実際)

2023年10月20日

研究の完了 (実際)

2023年10月20日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月11日

最初の投稿 (実際)

2026年6月17日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月17日

QC基準を満たした最後の更新が送信されました

2026年6月11日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

IPD 共有時間枠

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

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

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